Scholars@Duke
Hussein Rashid Al-Khalidi

Hussein Rashid Al-Khalidi

Professor of Biostatistics & Bioinformatics
Biostatistics & Bioinformatics, Division of Biostatistics
hussein.al-khalidi@duke.edu
Duke Box 3850, Durham, NC 27710
200 Morris Street, 6830 200 Morris Street, Durham, NC 27701

Selected Publications

RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial: Study rationale and design.

Journal Article Am Heart J · November 2024 Out-of-hospital cardiac arrest (OHCA) occurs in nearly 350,000 people each year in the United States (US). Despite advances in pre and in-hospital care, OHCA survival remains low and is highly variable across systems and regions. The critical barrier to im ... Full text Open Access Link to item Cite

Migraine May Represent an Independent Risk Factor for Retinal Stroke: A Population-Based Cohort Study.

Journal Article Clin Neurol Neurosurg · November 2024 INTRODUCTION: Migraine is an established risk factor for cerebral ischemic stroke, with an especially robust association in patients with migraine with aura. However, it is not known if migraine is a risk factor for retinal stroke (central or branch retina ... Full text Link to item Cite

Adjudication of Self-reported Symptomatic Stone Recurrence in the Prevention of Urinary Stones With Hydration Trial.

Journal Article Urology · September 4, 2024 OBJECTIVE: To assess accuracy of self-reported stone events in a large clinical trial by adjudication against the weight of documentation for spontaneous stone passage or surgical intervention. METHODS: Participants in the Prevention of Urinary Stones with ... Full text Link to item Cite

Effects of an Intervention to Improve Evidence-Based Care for People With Diabetes and Cardiovascular Disease Across Sex, Race, and Ethnicity Subgroups: Insights From the COORDINATE-Diabetes Trial.

Journal Article Circulation · July 16, 2024 BACKGROUND: Results from the COORDINATE-Diabetes trial (Coordinating Cardiology Clinics Randomized Trial of Interventions to Improve Outcomes - Diabetes) demonstrated that a multifaceted, clinic-based intervention increased prescription of evidence-based m ... Full text Link to item Cite

Using structured problem solving to promote fluid consumption in the prevention of urinary stones with hydration (PUSH) trial.

Journal Article BMC Nephrol · May 28, 2024 BACKGROUND: Structured Problem Solving (SPS) is a patient-centered approach to promoting behavior change that relies on productive collaboration between coaches and participants and reinforces participant autonomy. We aimed to describe the design, implemen ... Full text Link to item Cite

Depression following small vessel stroke is common and more prevalent in women.

Journal Article J Stroke Cerebrovasc Dis · May 2024 OBJECTIVES: We sought to examine the frequency of depression after small vessel-type stroke (SVS) and associated risk factors. MATERIALS AND METHODS: We conducted a retrospective analysis of a prospective cohort of patients enrolled in the American Stroke ... Full text Open Access Link to item Cite

Prognostic Impact of Sinus Rhythm in Atrial Fibrillation Patients: Separating Rhythm Outcomes From Randomized Strategy Findings From the CABANA Trial.

Journal Article Circ Arrhythm Electrophysiol · May 2024 BACKGROUND: Clinically detected atrial fibrillation (AF) is associated with a significant increase in mortality and other adverse cardiovascular events. Since the advent of effective methods for AF rhythm control, investigators have attempted to determine ... Full text Open Access Link to item Cite

Remote Follow-up in a Heart Failure Pragmatic Trial: Insights From the CONNECT-HF.

Journal Article J Card Fail · April 8, 2024 BACKGROUND: Randomized controlled trials typically require study-specific visits, which can burden participants and sites. Remote follow-up, such as centralized call centers for participant-reported or site-reported, holds promise for reducing costs and en ... Full text Link to item Cite

Regional differences in outcomes with ablation versus drug therapy for atrial fibrillation: Results from the CABANA trial.

Journal Article Am Heart J · April 2024 BACKGROUND: The finding of unexpected variations in treatment benefits by geographic region in international clinical trials raises complex questions about the interpretation and generalizability of trial findings. We observed such geographical variations ... Full text Open Access Link to item Cite

Contribution of Hypersensitivity to Postureteroscopy Ureteral Stent Pain: Findings From Study to Enhance Understanding of Stent-associated Symptoms.

Journal Article Urology · February 2024 OBJECTIVE: To examine the relationships between preoperative hypersensitivity to pain and central sensitization, and postoperative ureteral stent pain after ureteroscopy (URS) for urinary stones. METHODS: Adults enrolled in the STudy to Enhance uNderstandi ... Full text Link to item Cite

Detection of brain lesions after catheter ablation depends on imaging criteria: insights from AXAFA-AFNET 5 trial.

Journal Article Europace · December 6, 2023 AIMS: Left atrial catheter ablation is well established in patients with symptomatic atrial fibrillation (AF) but associated with risk of embolism to the brain. The present analysis aims to assess the impact of diffusion-weighted imaging (DWI) slice thickn ... Full text Link to item Cite

Comparison of an Initial Risk-Based Testing Strategy vs Usual Testing in Stable Symptomatic Patients With Suspected Coronary Artery Disease: The PRECISE Randomized Clinical Trial.

Journal Article JAMA Cardiol · October 1, 2023 IMPORTANCE: Trials showing equivalent or better outcomes with initial evaluation using coronary computed tomography angiography (cCTA) compared with stress testing in patients with stable chest pain have informed guidelines but raise questions about overte ... Full text Link to item Cite

Deferred Testing in Stable Outpatients With Suspected Coronary Artery Disease: A Prespecified Secondary Analysis of the PRECISE Randomized Clinical Trial.

Journal Article JAMA Cardiol · October 1, 2023 IMPORTANCE: Guidelines recommend deferral of testing for symptomatic people with suspected coronary artery disease (CAD) and low pretest probability. To our knowledge, no randomized trial has prospectively evaluated such a strategy. OBJECTIVE: To assess pr ... Full text Link to item Cite

Patients' Experiences With the Removal of a Ureteral Stent: Insights From In-depth Interviews With Participants in the USDRN STENTS Qualitative Cohort Study.

Journal Article Urology · August 2023 OBJECTIVE: To describe the experiences of patients undergoing stent removal in the USDRN Study to Enhance Understanding of Stent-Associated Symptoms (STENTS), a prospective, observational cohort study of patients with short-term ureteral stent placement po ... Full text Link to item Cite

Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 Pneumonia: A Randomized Clinical Trial.

Journal Article JAMA · July 25, 2023 IMPORTANCE: Immune dysregulation contributes to poorer outcomes in COVID-19. OBJECTIVE: To investigate whether abatacept, cenicriviroc, or infliximab provides benefit when added to standard care for COVID-19 pneumonia. DESIGN, SETTING, AND PARTICIPANTS: Ra ... Full text Open Access Link to item Cite

Clinical and cost implications of deferred testing in low-risk patients with stable chest pain: a simulation using the PROMISE trial.

Journal Article Am Heart J · July 2023 Current guidelines recommend a deferred testing approach in low-risk patients presenting with stable chest pain. After simulating a deferred testing approach using the PROMISE Minimal Risk Score to identify 915 minimal risk participants with cost data from ... Full text Link to item Cite

Apixaban or Warfarin in Patients with an On-X Mechanical Aortic Valve.

Journal Article NEJM Evid · July 2023 BACKGROUND: Vitamin K antagonists are the only oral anticoagulants approved to prevent valve thrombosis and valve-related thromboembolism in patients with mechanical heart valves. Whether patients with an On-X mechanical aortic valve can be safely anticoag ... Full text Link to item Cite

The Patient Voice: Stent Experiences After Ureteroscopy-Insights from In-Depth Interviews with Participants in the USDRN STENTS Nested Qualitative Cohort Study.

Journal Article J Endourol · June 2023 Purpose: Ureteral stents are commonly used after ureteroscopy and cause significant discomfort, yet qualitative perspectives on patients' stent experiences remain unknown. We describe psychological, functional, and interpersonal effects of post-ureteroscop ... Full text Link to item Cite

Risk Factors for Increased Stent-associated Symptoms Following Ureteroscopy for Urinary Stones: Results From STENTS.

Journal Article J Urol · May 2023 PURPOSE: The STudy to Enhance uNderstanding of sTent-associated Symptoms sought to identify risk factors for pain and urinary symptoms, as well as how these symptoms interfere with daily activities after ureteroscopy for stone treatment. MATERIALS AND METH ... Full text Link to item Cite

Coordinated Care to Optimize Cardiovascular Preventive Therapies in Type 2 Diabetes: A Randomized Clinical Trial.

Journal Article JAMA · April 18, 2023 IMPORTANCE: Evidence-based therapies to reduce atherosclerotic cardiovascular disease risk in adults with type 2 diabetes are underused in clinical practice. OBJECTIVE: To assess the effect of a coordinated, multifaceted intervention of assessment, educati ... Full text Link to item Cite

Association Between Hospital-Documented Atrial Fibrillation and Central Retinal Artery Occlusion.

Journal Article Stroke · April 2023 BACKGROUND: Carotid stenosis is thought to be the primary risk factor for central retinal artery occlusion (CRAO); however, it is not known whether atrial fibrillation (AF)-a cardiac arrhythmia that underlies over 25% of cerebral ischemic strokes-predispos ... Full text Link to item Cite

Effects of Ablation Versus Drug Therapy on Quality of Life by Sex in Atrial Fibrillation: Results From the CABANA Trial.

Journal Article J Am Heart Assoc · February 7, 2023 Background Women with atrial fibrillation (AF) demonstrate more AF-related symptoms and worse quality of life (QOL). Whether increased use of ablation in women reduces sex-related QOL differences is unknown. Sex-related outcomes for ablation versus drug th ... Full text Open Access Link to item Cite

Coordinating Cardiology clinics randomized trial of interventions to improve outcomes (COORDINATE) - Diabetes: rationale and design.

Journal Article Am Heart J · February 2023 Several medications that are proven to reduce cardiovascular events exist for individuals with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease, however they are substantially underused in clinical practice. Clinician, patient, an ... Full text Link to item Cite

Abstract 30: Association Between Hospital-ascertained Atrial Fibrillation And Central Retinal Artery Occlusion: A Study Of 12 Million Patients

Conference Stroke · February 2023 Introduction: Atrial fibrillation (AF) is a major risk factor for cerebral ischemic stroke. However, it is not known whether AF predicts the development of central retinal artery occlusion (CRAO), a f ... Full text Cite

Suitability of Automated Writing Measures for Clinical Trial Outcome in Writer's Cramp.

Journal Article Mov Disord · January 2023 BACKGROUND: Writer's cramp (WC) dystonia is a rare disease that causes abnormal postures during the writing task. Successful research studies for WC and other forms of dystonia are contingent on identifying sensitive and specific measures that relate to th ... Full text Open Access Link to item Cite

Apixaban for Patients With Atrial Fibrillation on Hemodialysis: A Multicenter Randomized Controlled Trial.

Journal Article Circulation · December 6, 2022 BACKGROUND: There are no randomized data evaluating the safety or efficacy of apixaban for stroke prevention in patients with end-stage kidney disease on hemodialysis and with atrial fibrillation (AF). METHODS: The RENAL-AF trial (Renal Hemodialysis Patien ... Full text Link to item Cite

Optimal medical therapy with or without surgical revascularization and long-term outcomes in ischemic cardiomyopathy.

Journal Article J Thorac Cardiovasc Surg · December 2022 OBJECTIVES: Optimal medical therapy in patients with heart failure and coronary artery disease is associated with improved outcomes. However, whether this association is influenced by the performance of coronary artery bypass grafting is less well establis ... Full text Link to item Cite

Influence of atrial fibrillation type on outcomes of ablation vs. drug therapy: results from CABANA.

Journal Article Europace · October 13, 2022 AIMS: Influence of atrial fibrillation (AF) type on outcomes seen with catheter ablation vs. drug therapy is incompletely understood. This study assesses the impact of AF type on treatment outcomes in the Catheter Ablation vs. Antiarrhythmic Drug Therapy f ... Full text Open Access Link to item Cite

The Association of Digital Health Application Use With Heart Failure Care and Outcomes: Insights From CONNECT-HF.

Journal Article J Card Fail · October 2022 BACKGROUND: It is unknown whether digital applications can improve guideline-directed medical therapy (GDMT) and outcomes in heart failure with reduced ejection fraction (HFrEF). METHODS AND RESULTS: Care Optimization Through Patient and Hospital Engagemen ... Full text Link to item Cite

Abatacept for Treatment of Adults Hospitalized with Moderate or Severe Covid-19.

Journal Article medRxiv · September 26, 2022 BACKGROUND: We investigated whether abatacept, a selective costimulation modulator, provides additional benefit when added to standard-of-care for patients hospitalized with Covid-19. METHODS: We conducted a master protocol to investigate immunomodulators ... Full text Link to item Cite

Cost-Effectiveness of Catheter Ablation Versus Antiarrhythmic Drug Therapy in Atrial Fibrillation: The CABANA Randomized Clinical Trial.

Journal Article Circulation · August 16, 2022 BACKGROUND: In the CABANA trial (Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation), catheter ablation did not significantly reduce the primary end point of death, disabling stroke, serious bleeding, or cardiac arrest compared with d ... Full text Link to item Cite

Health System-Level Performance in Prescribing Guideline-Directed Medical Therapy for Patients With Heart Failure With Reduced Ejection Fraction: Results From the CONNECT-HF Trial.

Journal Article J Card Fail · August 2022 BACKGROUND: Health system-level interventions to improve use of guideline-directed medical therapy (GDMT) often fail in the acute care setting. We sought to identify factors associated with high performance in adoption of GDMT among health systems in CONNE ... Full text Link to item Cite

Elevated Urinary Rab10 Phosphorylation in Idiopathic Parkinson Disease.

Journal Article Mov Disord · July 2022 BACKGROUND: Pathogenic leucine-rich repeat kinase 2 LRRK2 mutations may increase LRRK2 kinase activity and Rab substrate phosphorylation. Genetic association studies link variation in LRRK2 to idiopathic Parkinson disease (iPD) risk. OBJECTIVES: Through me ... Full text Link to item Cite

Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants: A Randomized Clinical Trial.

Journal Article JAMA Netw Open · May 2, 2022 IMPORTANCE: Only about half of patients with atrial fibrillation (AF) who are at increased risk for stroke are treated with an oral anticoagulant (OAC), despite guideline recommendations for their use. Educating patients with AF about prevention of stroke ... Full text Link to item Cite

Quality of life impact and recovery after ureteroscopy and stent insertion: insights from daily surveys in STENTS.

Journal Article BMC Urol · April 6, 2022 BACKGROUND: Our objective was to describe day-to-day evolution and variations in patient-reported stent-associated symptoms (SAS) in the STudy to Enhance uNderstanding of sTent-associated Symptoms (STENTS), a prospective multicenter observational cohort st ... Full text Link to item Cite

MRI-Detected Brain Lesions and Cognitive Function in Patients With Atrial Fibrillation Undergoing Left Atrial Catheter Ablation in the Randomized AXAFA-AFNET 5 Trial.

Journal Article Circulation · March 22, 2022 BACKGROUND: We aimed to assess the prevalence of ischemic brain lesions detected by magnetic resonance imaging and their association with cognitive function 3 months after first-time ablation using continuous oral anticoagulation in patients with paroxysma ... Full text Link to item Cite

Association Between Age and Outcomes of Catheter Ablation Versus Medical Therapy for Atrial Fibrillation: Results From the CABANA Trial.

Journal Article Circulation · March 15, 2022 BACKGROUND: Observational data suggest that catheter ablation may be safe and effective to treat younger and older patients with atrial fibrillation. No large, randomized trial has examined this issue. This report describes outcomes according to age at ent ... Full text Open Access Link to item Cite

Cost-Effectiveness of Coronary Artery Bypass Surgery Versus Medicine in Ischemic Cardiomyopathy: The STICH Randomized Clinical Trial.

Journal Article Circulation · March 15, 2022 BACKGROUND: The STICH Randomized Clinical Trial (Surgical Treatment for Ischemic Heart Failure) demonstrated that coronary artery bypass grafting (CABG) reduced all-cause mortality rates out to 10 years compared with medical therapy alone (MED) in patients ... Full text Link to item Cite

Perioperative Outcomes of Thymectomy in Myasthenia Gravis: A Thoracic Surgery Database Analysis.

Journal Article Ann Thorac Surg · March 2022 BACKGROUND: There is clinical equipoise regarding the perioperative and long-term outcomes of autoimmune myasthenia gravis (MG) patients undergoing open vs minimally invasive thymectomy, particularly for nonthymomatous MG. This analysis utilizes multicente ... Full text Link to item Cite

The prospective randomized trial of the optimal evaluation of cardiac symptoms and revascularization: Rationale and design of the PRECISE trial.

Journal Article Am Heart J · March 2022 BACKGROUND: Clinicians vary widely in their preferred diagnostic approach to patients with non-acute chest pain. Such variation exposes patients to potentially avoidable risks, as well as inefficient care with increased costs and unresolved patient concern ... Full text Link to item Cite

Renal function and coronary bypass surgery in patients with ischemic heart failure.

Journal Article J Thorac Cardiovasc Surg · February 2022 OBJECTIVE: Chronic kidney disease is a known risk factor in cardiovascular disease, but its influence on treatment effect of bypass surgery remains unclear. We assessed the influence of chronic kidney disease on 10-year mortality and cardiovascular outcome ... Full text Link to item Cite

Use of Lipid-, Blood Pressure-, and Glucose-Lowering Pharmacotherapy in Patients With Type 2 Diabetes and Atherosclerotic Cardiovascular Disease.

Journal Article JAMA Netw Open · February 1, 2022 IMPORTANCE: Based on contemporary estimates in the US, evidence-based therapies for cardiovascular risk reduction are generally underused among patients with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD). OBJECTIVE: To determine the us ... Full text Link to item Cite

Effect of a Hospital and Postdischarge Quality Improvement Intervention on Clinical Outcomes and Quality of Care for Patients With Heart Failure With Reduced Ejection Fraction: The CONNECT-HF Randomized Clinical Trial.

Journal Article JAMA · July 27, 2021 IMPORTANCE: Adoption of guideline-directed medical therapy for patients with heart failure is variable. Interventions to improve guideline-directed medical therapy have failed to consistently achieve target metrics, and limited data exist to inform efforts ... Full text Link to item Cite

Incorporating SGLT2i and GLP-1RA for Cardiovascular and Kidney Disease Risk Reduction: Call for Action to the Cardiology Community.

Journal Article Circulation · July 6, 2021 Multiple sodium glucose cotransporter-2 inhibitors (SGLT-2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA) have been shown to impart significant cardiovascular and kidney benefits, but are underused in clinical practice. Both SGLT-2i and GLP-1RA ... Full text Link to item Cite

Ablation Versus Drug Therapy for Atrial Fibrillation in Racial and Ethnic Minorities.

Journal Article Journal of the American College of Cardiology · July 2021 BackgroundRhythm control strategies for atrial fibrillation (AF), including catheter ablation, are substantially underused in racial/ethnic minorities in North America.ObjectivesThis study sought to describe outcomes in the CABANA trial a ... Full text Open Access Cite

Study to Enhance Understanding of Stent-Associated Symptoms: Rationale and Study Design.

Journal Article J Endourol · June 2021 Background: Ureteral stents are commonly employed after ureteroscopy to treat urinary stone disease, but the devices impose a substantial burden of stent-associated symptoms (SAS), including pain and urinary side effects. The NIDDK (National Institute of D ... Full text Link to item Cite

Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial.

Journal Article Am J Kidney Dis · June 2021 RATIONALE & OBJECTIVE: Although maintaining high fluid intake is an effective low-risk intervention for the secondary prevention of urinary stone disease, many patients with stones do not increase their fluid intake. STUDY DESIGN: We describe the rationale ... Full text Open Access Link to item Cite

Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results From the CABANA Trial.

Journal Article Circulation · April 6, 2021 BACKGROUND: In patients with heart failure and atrial fibrillation (AF), several clinical trials have reported improved outcomes, including freedom from AF recurrence, quality of life, and survival, with catheter ablation. This article describes the treatm ... Full text Open Access Link to item Cite

Association Between Sex and Treatment Outcomes of Atrial Fibrillation Ablation Versus Drug Therapy: Results From the CABANA Trial.

Journal Article Circulation · February 16, 2021 BACKGROUND: Among patients with atrial fibrillation (AF), women are less likely to receive catheter ablation and may have more complications and less durable results. Most information about sex-specific differences after ablation comes from observational d ... Full text Open Access Link to item Cite

Copula-frailty models for recurrent event data based on Monte Carlo EM algorithm

Journal Article Journal of Statistical Computation and Simulation · January 1, 2021 Multi-type recurrent events are often encountered in medical applications when two or more different event types could repeatedly occur over an observation period. For example, patients may experience recurrences of multi-type nonmelanoma skin cancers in a ... Full text Cite

Changes in quality of life, cognition and functional status following catheter ablation of atrial fibrillation.

Journal Article Heart · December 2020 OBJECTIVE: To investigate changes in quality of life (QoL), cognition and functional status according to arrhythmia recurrence after atrial fibrillation (AF) ablation. METHODS: We compared QoL, cognition and functional status in patients with recurrent atr ... Full text Link to item Cite

Underuse of oral anticoagulants in privately insured patients with atrial fibrillation: A population being targeted by the IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib).

Journal Article Am Heart J · November 2020 BACKGROUND: Many studies showing underuse of oral anticoagulants (OACs) in patients with atrial fibrillation (AF) predated the advent of the non-vitamin K antagonist OACs. We retrospectively examined use of OACs in a large commercially insured population. ... Full text Link to item Cite

Cause of Death Among Patients With Peripheral Artery Disease: Insights From the EUCLID Trial.

Journal Article Circ Cardiovasc Qual Outcomes · November 2020 BACKGROUND: Peripheral artery disease is common and associated with high mortality. There are limited data detailing causes of death among patients with peripheral artery disease. METHODS: EUCLID (Examining Use of Ticagrelor in Peripheral Artery Disease) w ... Full text Link to item Cite

Predictors of recurrence of atrial fibrillation within the first 3 months after ablation.

Journal Article Europace · September 1, 2020 AIMS: Freedom from atrial fibrillation (AF) at 1 year can be achieved in 50-70% of patients undergoing catheter ablation. Recurrent AF early after ablation most commonly terminates spontaneously without further interventional treatment but is associated wi ... Full text Link to item Cite

Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial.

Journal Article Clin Trials · August 2020 IMPACT-AFib was an 80,000-patient randomized clinical trial implemented by five US insurance companies (health plans) aimed at increasing the use of oral anticoagulants by individuals with atrial fibrillation who were at high risk of stroke and not on trea ... Full text Link to item Cite

Sex differences in catheter ablation of atrial fibrillation: results from AXAFA-AFNET 5.

Journal Article Europace · July 1, 2020 AIMS: Study sex-differences in efficacy and safety of atrial fibrillation (AF) ablation. METHODS AND RESULTS: We assessed first AF ablation outcomes on continuous anticoagulation in 633 patients [209 (33%) women and 424 (67%) men] in a pre-specified subgro ... Full text Link to item Cite

Catheterization Laboratory Activation Time in Patients Transferred With ST-Segment-Elevation Myocardial Infarction: Insights From the Mission: Lifeline STEMI Accelerator-2 Project.

Journal Article Circ Cardiovasc Qual Outcomes · July 2020 BACKGROUND: Catheterization laboratory (cath lab) activation time is a newly available process measure for patients with ST-segment-elevation myocardial infarction requiring inter-hospital transfers for primary percutaneous coronary intervention that refle ... Full text Link to item Cite

Recurrence of Atrial Fibrillation After Catheter Ablation or Antiarrhythmic Drug Therapy in the CABANA Trial.

Journal Article J Am Coll Cardiol · June 30, 2020 BACKGROUND: The CABANA (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) trial randomized 2,204 patients with atrial fibrillation (AF) to catheter ablation or drug therapy. Analysis by intention-to-treat showed a nonsignificant ... Full text Open Access Link to item Cite

Cardiac remodeling after large ST-elevation myocardial infarction in the current therapeutic era.

Journal Article Am Heart J · May 2020 BACKGROUND: The evolution and clinical impact of cardiac remodeling after large ST-elevation myocardial infarction (STEMI) is not well delineated in the current therapeutic era. METHODS: The PRESERVATION I trial longitudinally assessed cardiac structure an ... Full text Link to item Cite

Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure: Rationale and design of CONNECT-HF.

Journal Article Am Heart J · February 2020 Many therapies have been shown to improve outcomes for patients with heart failure (HF) in controlled settings, but there are limited data available to inform best practices for hospital and post-discharge quality improvement initiatives. The CONNECT-HF st ... Full text Link to item Cite

Opportunities for enhancing the care of older patients with ST-elevation myocardial infarction presenting for primary percutaneous coronary intervention: Rationale and design of the SAFE-STEMI for Seniors trial.

Journal Article Am Heart J · December 2019 Advanced age is directly related to worse outcomes following ST-elevation myocardial infarction (STEMI) and higher complication rates from antithrombotic therapies and primary percutaneous coronary intervention (PCI). Often excluded from clinical trials, s ... Full text Link to item Cite

CABG Improves Outcomes in Patients With Ischemic Cardiomyopathy: 10-Year Follow-Up of the STICH Trial.

Journal Article JACC Heart Fail · October 2019 OBJECTIVES: The authors investigated the impact of coronary artery bypass grafting (CABG) on first and recurrent hospitalization in this population. BACKGROUND: In the STICH (Surgical Treatment for Ischemic Heart Failure) trial, CABG reduced all-cause deat ... Full text Link to item Cite

Does prior coronary angioplasty affect outcomes of surgical coronary revascularization? Insights from the STICH trial.

Journal Article Int J Cardiol · September 15, 2019 BACKGROUND: The STICH trial showed superiority of coronary artery bypass plus medical treatment (CABG) over medical treatment alone (MED) in patients with left ventricular ejection fraction (LVEF) ≤35%. In previous publications, percutaneous coronary inter ... Full text Link to item Cite

Myocardial Viability and Long-Term Outcomes in Ischemic Cardiomyopathy.

Journal Article N Engl J Med · August 22, 2019 BACKGROUND: The role of assessment of myocardial viability in identifying patients with ischemic cardiomyopathy who might benefit from surgical revascularization remains controversial. Furthermore, although improvement in left ventricular function is one o ... Full text Link to item Cite

Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial.

Journal Article JAMA · April 2, 2019 IMPORTANCE: Catheter ablation is effective in restoring sinus rhythm in atrial fibrillation (AF), but its effects on long-term mortality and stroke risk are uncertain. OBJECTIVE: To determine whether catheter ablation is more effective than conventional me ... Full text Open Access Link to item Cite

Stress Testing Versus CT Angiography in Patients With Diabetes and Suspected Coronary Artery Disease.

Journal Article J Am Coll Cardiol · March 5, 2019 BACKGROUND: The optimal noninvasive test (NIT) for patients with diabetes and stable symptoms of coronary artery disease (CAD) is unknown. OBJECTIVES: The purpose of this study was to assess whether a diagnostic strategy based on coronary computed tomograp ... Full text Link to item Cite

Burden of medical co-morbidities and benefit from surgical revascularization in patients with ischaemic cardiomyopathy.

Journal Article Eur J Heart Fail · March 2019 AIMS: The landmark STICH trial found that surgical revascularization compared to medical therapy alone improved survival in patients with heart failure (HF) of ischaemic aetiology and an ejection fraction (EF) ≤ 35%. However, the interaction between the bu ... Full text Link to item Cite

FDA-Catalyst-Using FDA's Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial.

Journal Article Clin Trials · February 2019 BACKGROUND: The US Food and Drug Administration's Sentinel Initiative is well positioned to support pragmatic clinical trials. FDA-Catalyst combines direct contact with health plan members and/or providers with data in the Sentinel infrastructure. Here, we ... Full text Link to item Cite

Society of Thoracic Surgeons Risk Score and EuroSCORE-2 Appropriately Assess 30-Day Postoperative Mortality in the STICH Trial and a Contemporary Cohort of Patients With Left Ventricular Dysfunction Undergoing Surgical Revascularization.

Journal Article Circ Heart Fail · November 2018 BACKGROUND: The STICH trial (Surgical Treatment for Ischemic Heart Failure) demonstrated a survival benefit of coronary artery bypass grafting in patients with ischemic cardiomyopathy and left ventricular dysfunction. The Society of Thoracic Surgeons (STS) ... Full text Link to item Cite

Delays in Primary Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction Patients Presenting With Cardiogenic Shock.

Journal Article JACC Cardiovasc Interv · September 24, 2018 OBJECTIVES: This study sought to examine whether quality improvement initiatives across multiple ST-segment elevation myocardial infarction (STEMI) systems translated to faster first medical contact (FMC)-to-device times for patients presenting with cardio ... Full text Link to item Cite

Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation.

Journal Article Eur Heart J · August 21, 2018 AIMS: It is recommended to perform atrial fibrillation ablation with continuous anticoagulation. Continuous apixaban has not been tested. METHODS AND RESULTS: We compared continuous apixaban (5 mg b.i.d.) to vitamin K antagonists (VKA, international normal ... Full text Link to item Cite

Variability in Ejection Fraction Measured By Echocardiography, Gated Single-Photon Emission Computed Tomography, and Cardiac Magnetic Resonance in Patients With Coronary Artery Disease and Left Ventricular Dysfunction.

Journal Article JAMA Netw Open · August 3, 2018 IMPORTANCE: Clinical decisions are frequently based on measurement of left ventricular ejection fraction (LVEF). Limited information exists regarding inconsistencies in LVEF measurements when determined by various imaging modalities and the potential impac ... Full text Link to item Cite

Japan-United States of America Harmonized Assessment by Randomized Multicentre Study of OrbusNEich's Combo StEnt (Japan-USA HARMONEE) study: primary results of the pivotal registration study of combined endothelial progenitor cell capture and drug-eluting stent in patients with ischaemic coronary disease and non-ST-elevation acute coronary syndrome.

Journal Article Eur Heart J · July 7, 2018 AIMS: Harmonized Assessment by Randomized Multicentre Study of OrbusNEich's Combo StEnt (HARMONEE) (NCT02073565) was a randomized pivotal registration trial of the Combo stent, which combined sirolimus and an abluminal bioabsorbable polymer with a novel en ... Full text Link to item Cite

Impact of Intubation Time on Survival following Coronary Artery Bypass Grafting: Insights from the Surgical Treatment for Ischemic Heart Failure (STICH) Trial.

Journal Article J Cardiothorac Vasc Anesth · June 2018 OBJECTIVE: The authors aimed to assess determinants of intubation time and evaluate its impact on 30-day and 1-year postoperative survival in Surgical Treatment for Ischemic Heart Failure (STICH) trial patients. DESIGN, SETTING, PARTICIPANTS, AND INTERVENT ... Full text Link to item Cite

A genotype-directed comparative effectiveness trial of Bucindolol and metoprolol succinate for prevention of symptomatic atrial fibrillation/atrial flutter in patients with heart failure: Rationale and design of the GENETIC-AF trial.

Journal Article Am Heart J · May 2018 BACKGROUND: Few therapies are available for the safe and effective treatment of atrial fibrillation (AF) in patients with heart failure. Bucindolol is a non-selective beta-blocker with mild vasodilator activity previously found to have accentuated antiarrh ... Full text Link to item Cite

Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial: Study Rationale and Design.

Journal Article Am Heart J · May 2018 The Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA,NCT00911508)(1) trial is testing the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of eliminating atrial fibril ... Full text Link to item Cite

Impact of Regionalization of ST-Segment-Elevation Myocardial Infarction Care on Treatment Times and Outcomes for Emergency Medical Services-Transported Patients Presenting to Hospitals With Percutaneous Coronary Intervention: Mission: Lifeline Accelerator-2.

Journal Article Circulation · January 23, 2018 BACKGROUND: Regional variations in reperfusion times and mortality in patients with ST-segment-elevation myocardial infarction are influenced by differences in coordinating care between emergency medical services (EMS) and hospitals. Building on the Accele ... Full text Link to item Cite

Cardiac-Specific Conversion Factors to Estimate Radiation Effective Dose From Dose-Length Product in Computed Tomography.

Journal Article JACC Cardiovasc Imaging · January 2018 OBJECTIVES: This study sought to determine updated conversion factors (k-factors) that would enable accurate estimation of radiation effective dose (ED) for coronary computed tomography angiography (CTA) and calcium scoring performed on 12 contemporary sca ... Full text Link to item Cite

Six-minute walk distance after coronary artery bypass grafting compared with medical therapy in ischaemic cardiomyopathy.

Journal Article Open Heart · 2018 BACKGROUND: In patients with ischaemic left ventricular dysfunction, coronary artery bypass surgery (CABG) may decrease mortality, but it is not known whether CABG improves functional capacity. OBJECTIVE: To determine whether CABG compared with medical the ... Full text Open Access Link to item Cite

Impact of Diabetes Mellitus on the Evaluation of Stable Chest Pain Patients: Insights From the PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) Trial.

Journal Article J Am Heart Assoc · October 31, 2017 BACKGROUND: The impact of diabetes mellitus on the clinical presentation and noninvasive test (NIT) results among stable outpatients presenting with symptoms suggestive of coronary artery disease (CAD) has not been well described. METHODS AND RESULTS: The ... Full text Link to item Cite

Impact of Regional Systems of Care on Disparities in Care Among Female and Black Patients Presenting With ST-Segment-Elevation Myocardial Infarction.

Journal Article J Am Heart Assoc · October 24, 2017 BACKGROUND: The American Heart Association Mission: Lifeline STEMI (ST-segment-elevation myocardial infarction) Systems Accelerator program, conducted in 16 regions across the United States to improve key care processes, resulted in more patients being tre ... Full text Link to item Cite

A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial.

Journal Article Lancet · October 14, 2017 BACKGROUND: Oral anticoagulation is underused in patients with atrial fibrillation. We assessed the impact of a multifaceted educational intervention, versus usual care, on oral anticoagulant use in patients with atrial fibrillation. METHODS: This study wa ... Full text Link to item Cite

Improvement in Care and Outcomes for Emergency Medical Service-Transported Patients With ST-Elevation Myocardial Infarction (STEMI) With and Without Prehospital Cardiac Arrest: A Mission: Lifeline STEMI Accelerator Study.

Journal Article J Am Heart Assoc · October 11, 2017 BACKGROUND: Patients with ST-elevation myocardial infarction (STEMI) with out-of-hospital cardiac arrest (OHCA) may benefit from direct transport to a percutaneous cardiac intervention (PCI) hospital but have previously been less likely to bypass local non ... Full text Link to item Cite

Regional differences in presentation and antithrombotic treatment of patients with atrial fibrillation: Baseline characteristics from a clustered randomized trial to IMProve treatment with AntiCoagulanTs in patients with atrial fibrillation (IMPACT-AF).

Journal Article Am Heart J · October 2017 UNLABELLED: Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide. However, there are few contemporary comparative data on AF from middle-income countries. METHODS: Baseline characteristics of the IMPACT-AF trial were analyzed to asses ... Full text Link to item Cite

Regional left ventricular function does not predict survival in ischaemic cardiomyopathy after cardiac surgery.

Journal Article Heart · September 2017 OBJECTIVES: To define the prognostic contribution of global and regional left ventricular (LV) function measurements in patients with ischaemic cardiomyopathy randomised to coronary artery bypass graft surgery (CABG) with (n=501) or without (n=499) surgica ... Full text Link to item Cite

The Metabolic Syndrome and Risk of Sudden Cardiac Death: The Atherosclerosis Risk in Communities Study.

Journal Article J Am Heart Assoc · August 23, 2017 BACKGROUND: Prior studies have demonstrated a link between the metabolic syndrome and increased risk of cardiovascular mortality. Whether the metabolic syndrome is associated with sudden cardiac death is uncertain. METHODS AND RESULTS: We characterized the ... Full text Link to item Cite

Novel Genetic Triggers and Genotype-Phenotype Correlations in Patients With Left Ventricular Noncompaction.

Journal Article Circ Cardiovasc Genet · August 2017 BACKGROUND: Left ventricular noncompaction (LVNC) is a genetically and phenotypically heterogeneous disease and, although increasingly recognized in clinical practice, there is a lack of widely accepted diagnostic criteria. We sought to identify novel gene ... Full text Link to item Cite

Value of Cardiovascular Magnetic Resonance Imaging-Derived Baseline Left Ventricular Ejection Fraction and Volumes for Precise Risk Stratification of Patients With Ischemic Cardiomyopathy: Insights From the Surgical Treatment for Ischemic Heart Failure (STICH) Trial.

Journal Article JAMA Cardiol · May 1, 2017 This study tests the hypothesis that cardiovascular magnetic resonance–derived left ventricular ejection fraction and volumes would provide improved risk stratification in patients undergoing coronary artery bypass surgery for ischemic cardiomyopathy. ... Full text Link to item Cite

Rationale and design of the Japan-USA harmonized assessment by randomized, multicenter study of OrbusNEich's combo StEnt (Japan-USA HARMONEE): Assessment of a novel DES platform for percutaneous coronary revascularization in patients with ischemic coronary disease and non-ST-elevation acute coronary syndrome.

Journal Article Am Heart J · May 2017 Tissue trauma associated with stent implantation continues to generate early thrombosis rates of 0.9% to 1.3% for both bare-metal and drug-eluting stent platforms. The Combo sirolimus-eluting stent combines an abluminal, bioabsorbable polymer with a lumina ... Full text Link to item Cite

Identification of Patients With Stable Chest Pain Deriving Minimal Value From Noninvasive Testing: The PROMISE Minimal-Risk Tool, A Secondary Analysis of a Randomized Clinical Trial.

Journal Article JAMA Cardiol · April 1, 2017 IMPORTANCE: Guidelines recommend noninvasive testing for patients with stable chest pain, although many subsequently have normal test results and no adverse clinical events. OBJECTIVE: To describe a risk tool developed to use only pretest clinical data to ... Full text Link to item Cite

Association of Rapid Care Process Implementation on Reperfusion Times Across Multiple ST-Segment-Elevation Myocardial Infarction Networks.

Journal Article Circ Cardiovasc Interv · January 2017 BACKGROUND: The Mission: Lifeline STEMI Systems Accelerator program, implemented in 16 US metropolitan regions, resulted in more patients receiving timely reperfusion. We assessed whether implementing key care processes was associated with system performan ... Full text Link to item Cite

Rationale and design of AXAFA-AFNET 5: an investigator-initiated, randomized, open, blinded outcome assessment, multi-centre trial to comparing continuous apixaban to vitamin K antagonists in patients undergoing atrial fibrillation catheter ablation.

Journal Article Europace · January 2017 AIMS: Catheter ablation is the most efficacious rhythm control therapy in atrial fibrillation (AF) patients. There is growing evidence that catheter ablation procedures are best performed during continuous oral anticoagulation, but outcomes are variable de ... Full text Link to item Cite

Safety of coronary CT angiography and functional testing for stable chest pain in the PROMISE trial: A randomized comparison of test complications, incidental findings, and radiation dose.

Journal Article J Cardiovasc Comput Tomogr · 2017 BACKGROUND: Coronary computed tomography angiography (CTA) and functional testing strategies for stable chest pain yield similar outcomes; one aspect that may guide test choice is safety. METHODS: We compared test safety (test complications, incidental fin ... Full text Open Access Link to item Cite

Multivariate frailty models for multi-type recurrent event data and its application to cancer prevention trial

Journal Article Computational Statistics and Data Analysis · September 1, 2016 Multi-type recurrent event data arise in many situations when two or more different event types may occur repeatedly over an observation period. For example, in a randomized controlled clinical trial to study the efficacy of nutritional supplements for ski ... Full text Cite

Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction.

Journal Article J Am Coll Cardiol · August 16, 2016 BACKGROUND: Bioabsorbable cardiac matrix (BCM) is a novel device that attenuates adverse left ventricular (LV) remodeling after large myocardial infarctions in experimental models. OBJECTIVES: This study aimed to analyze whether BCM, compared with saline c ... Full text Link to item Cite

The RENEW Trial: Efficacy and Safety of Intramyocardial Autologous CD34(+) Cell Administration in Patients With Refractory Angina.

Journal Article JACC Cardiovasc Interv · August 8, 2016 OBJECTIVES: This study tested whether intramyocardial (IM) administration of mobilized, purified autologous CD34(+) cells would improve total exercise time (TET) and angina frequency in patients with refractory angina. BACKGROUND: IM administration of auto ... Full text Link to item Cite

Regional Systems of Care Demonstration Project: American Heart Association Mission: Lifeline STEMI Systems Accelerator.

Journal Article Circulation · August 2, 2016 BACKGROUND: Up to 50% of patients fail to meet ST-segment-elevation myocardial infarction (STEMI) guideline goals recommending a first medical contact-to-device time of <90 minutes for patients directly presenting to percutaneous coronary intervention-capa ... Full text Link to item Cite

Relationship of Right Ventricular Size and Function with Respiratory Status in Duchenne Muscular Dystrophy.

Journal Article Pediatr Cardiol · June 2016 The relationship between pulmonary function and right ventricle (RV) in Duchenne muscular dystrophy (DMD) has not been evaluated. Using cardiac magnetic resonance (CMR), we describe the relationship of RV size and function with spirometry in a DMD cohort. ... Full text Link to item Cite

A clustered randomized trial to IMProve treatment with AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AF): design and rationale.

Journal Article Am Heart J · June 2016 Atrial fibrillation (AF) is common, increasing as the population ages, and a major cause of embolic stroke. While oral anticoagulation (OAC) is highly effective at preventing stroke in patients with AF, it continues to be underused in eligible patients wor ... Full text Link to item Cite

Coronary-Artery Bypass Surgery in Patients with Ischemic Cardiomyopathy.

Journal Article N Engl J Med · April 21, 2016 BACKGROUND: The survival benefit of a strategy of coronary-artery bypass grafting (CABG) added to guideline-directed medical therapy, as compared with medical therapy alone, in patients with coronary artery disease, heart failure, and severe left ventricul ... Full text Link to item Cite

Clinical predictors and outcomes of patients with left ventricular thrombus following ST-segment elevation myocardial infarction.

Journal Article J Thromb Thrombolysis · April 2016 We aimed to characterize the independent predictors of LVT following STEMI and the association with outcomes. The clinical predictors of left ventricular thrombus (LVT) formation after ST-segment elevation myocardial infarction (STEMI) are not well-defined ... Full text Link to item Cite

Importance of angina in patients with coronary disease, heart failure, and left ventricular systolic dysfunction: insights from STICH.

Journal Article J Am Coll Cardiol · November 10, 2015 BACKGROUND: Patients with left ventricular (LV) systolic dysfunction, coronary artery disease (CAD), and angina are often thought to have a worse prognosis and a greater prognostic benefit from coronary artery bypass graft (CABG) surgery than those without ... Full text Link to item Cite

The MitraClip and survival in patients with mitral regurgitation at high risk for surgery: A propensity-matched comparison.

Journal Article Am Heart J · November 2015 BACKGROUND: We compared 30-day and 1-year survival among high-risk mitral regurgitation (MR) patients treated with the MitraClip (Abbott Vascular, Abbott Park, IL) with matched non-surgically treated patients from the Duke Echocardiography Laboratory Datab ... Full text Link to item Cite

A randomized, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of intracoronary application of a novel bioabsorbable cardiac matrix for the prevention of ventricular remodeling after large ST-segment elevation myocardial infarction: Rationale and design of the PRESERVATION I trial.

Journal Article Am Heart J · November 2015 Postinfarction left ventricular (LV) remodeling can result in chronic heart failure and functional impairment. Although pharmacological strategies for established heart failure can be beneficial, preventing remodeling remains a challenge. Injectable bioabs ... Full text Link to item Cite

Management and outcomes in patients with moderate or severe functional mitral regurgitation and severe left ventricular dysfunction.

Journal Article Eur Heart J · October 21, 2015 AIMS: The management and outcomes of patients with functional moderate/severe mitral regurgitation and severe left ventricular (LV) systolic dysfunction are not well defined. We sought to determine the characteristics, management strategies, and outcomes o ... Full text Link to item Cite

Comparison of right and left ventricular function and size in Duchenne muscular dystrophy.

Journal Article Eur J Radiol · October 2015 INTRODUCTION: Right ventricular (RV) size and function in Duchenne muscular dystrophy (DMD) have not been well described. Using cardiac magnetic resonance (CMR) imaging we describe the relationship of RV and left ventricular (LV) size and function in a lar ... Full text Link to item Cite

Influence of Baseline Characteristics, Operative Conduct, and Postoperative Course on 30-Day Outcomes of Coronary Artery Bypass Grafting Among Patients With Left Ventricular Dysfunction: Results From the Surgical Treatment for Ischemic Heart Failure (STICH) Trial.

Journal Article Circulation · August 25, 2015 BACKGROUND: Patients with severe left ventricular dysfunction, ischemic heart failure, and coronary artery disease suitable for coronary artery bypass grafting (CABG) are at higher risk for surgical morbidity and mortality. Paradoxically, those patients wi ... Full text Link to item Cite

Clinical outcomes and management associated with major bleeding in patients with atrial fibrillation treated with apixaban or warfarin: insights from the ARISTOTLE trial.

Journal Article Eur Heart J · May 21, 2015 AIM: In the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial, apixaban compared with warfarin reduced the risk of stroke, major bleed, and death in patients with atrial fibrillation. In this ancillar ... Full text Link to item Cite

Primary prevention implantable cardioverter defibrillators in end-stage kidney disease patients on dialysis: a matched cohort study.

Journal Article Nephrol Dial Transplant · May 2015 BACKGROUND: Sudden cardiac death is the leading cause of death among end-stage kidney disease patients (ESKD) on dialysis, but the benefit of primary prevention implantable cardioverter defibrillators (ICDs) in this population is uncertain. We conducted th ... Full text Link to item Cite

Clinical impact of stress dose steroids in patients with septic shock: insights from the PROWESS-Shock trial.

Journal Article Crit Care · April 28, 2015 INTRODUCTION: The aim of our study was to evaluate the clinical impact of the administration of intravenous steroids, alone or in conjunction with drotrecogin-alfa (activated) (DrotAA), on the outcomes in septic shock patients. METHODS: We performed a sub- ... Full text Link to item Cite

Outcomes of anatomical versus functional testing for coronary artery disease.

Journal Article N Engl J Med · April 2, 2015 BACKGROUND: Many patients have symptoms suggestive of coronary artery disease (CAD) and are often evaluated with the use of diagnostic testing, although there are limited data from randomized trials to guide care. METHODS: We randomly assigned 10,003 sympt ... Full text Link to item Cite

Primary prevention implantable cardioverter-defibrillators and survival in older women.

Journal Article JACC Heart Fail · February 2015 OBJECTIVES: The purpose of this study was to assess the benefit of primary prevention implantable cardioverter defibrillators (ICDs) in women. BACKGROUND: Clinical trials of primary prevention ICDs enrolled a limited number of women. METHODS: Using a prope ... Full text Link to item Cite

Primary prevention implantable cardioverter-defibrillators in older racial and ethnic minority patients.

Journal Article Circ Arrhythm Electrophysiol · February 2015 BACKGROUND: Racial and ethnic minorities are under-represented in clinical trials of primary prevention implantable cardioverter-defibrillators (ICDs). This analysis investigates the association between primary prevention ICDs and mortality among Medicare, ... Full text Link to item Cite

Regional circumferential strain is a biomarker for disease severity in duchenne muscular dystrophy heart disease: a cross-sectional study.

Journal Article Pediatr Cardiol · January 2015 The aim of this study is to determine the contribution of strain ε cc in mid left ventricular (LV) segments to the reduction of composite LV circumferential ε cc in assess severity of duchenne muscular dystrophy (DMD) heart disease as assessed by cardiac m ... Full text Link to item Cite

Clinical impact of stress dose steroids in patients with septic shock: Insights from the PROWESS-Shock trial

Journal Article Critical Care · 2015 © 2015 Póvoa et al.; licensee BioMed Central.Introduction: The aim of our study was to evaluate the clinical impact of the administration of intravenous steroids, alone or in conjunction with drotrecogin-alfa (activated) (DrotAA), on the outcomes in septic ... Full text Cite

Survival after primary prevention implantable cardioverter-defibrillator placement among patients with chronic kidney disease.

Journal Article Circ Arrhythm Electrophysiol · October 2014 BACKGROUND: Guidelines recommend that implantable cardioverter-defibrillator (ICD) candidates have an estimated longevity of ≥1 year. Longevity can be affected by chronic kidney disease (CKD). METHODS AND RESULTS: Using the National Cardiovascular Data Reg ... Full text Link to item Cite

Losmapimod, a novel p38 mitogen-activated protein kinase inhibitor, in non-ST-segment elevation myocardial infarction: a randomised phase 2 trial.

Journal Article Lancet · September 27, 2014 BACKGROUND: p38 MAPK inhibition has potential myocardial protective effects. We assessed losmapimod, a potent oral p38 MAPK inhibitor, in patients with non-ST-segment elevation myocardial infarction (NSTEMI) in a double-blind, randomised, placebo-controlle ... Full text Link to item Cite

Association between prophylactic implantable cardioverter-defibrillators and survival in patients with left ventricular ejection fraction between 30% and 35%.

Journal Article JAMA · June 4, 2014 IMPORTANCE: Clinical trials of prophylactic implantable cardioverter-defibrillators (ICDs) have included a minority of patients with a left ventricular ejection fraction (LVEF) between 30% and 35%. Because a large number of ICDs in the United States are im ... Full text Link to item Cite

PROspective Multicenter Imaging Study for Evaluation of chest pain: rationale and design of the PROMISE trial.

Journal Article Am Heart J · June 2014 BACKGROUND: Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic ... Full text Link to item Cite

Regional systems of care demonstration project: Mission: Lifeline STEMI Systems Accelerator: design and methodology.

Journal Article Am Heart J · January 2014 ST-segment elevation myocardial infarction (STEMI) systems of care have been associated with significant improvement in use and timeliness of reperfusion. Consequently, national guidelines recommend that each community should develop a regional STEMI care ... Full text Link to item Cite

Prevalence and distribution of late gadolinium enhancement in a large population of patients with Duchenne muscular dystrophy: effect of age and left ventricular systolic function.

Journal Article J Cardiovasc Magn Reson · December 21, 2013 BACKGROUND: Duchenne muscular dystrophy (DMD), an X-linked disorder affects approximately 1 in 5000 males, is universally associated with heart disease. We previously identified myocardial disease by late gadolinium enhancement (LGE) in DMD subjects at var ... Full text Link to item Cite

Insights from the STICH trial: change in left ventricular size after coronary artery bypass grafting with and without surgical ventricular reconstruction.

Journal Article J Thorac Cardiovasc Surg · November 2013 OBJECTIVE: The present analysis of the Surgical Treatment for Ischemic Heart Failure randomized trial data examined the left ventricular volumes at baseline and 4 months after surgery to determine whether any magnitude of postoperative reduction in end-sys ... Full text Link to item Cite

Bypassing the emergency department and time to reperfusion in patients with prehospital ST-segment-elevation: findings from the reperfusion in acute myocardial infarction in Carolina Emergency Departments project.

Journal Article Circ Cardiovasc Interv · August 2013 BACKGROUND: Among patients identified prehospital with ST-segment-elevation myocardial infarction, emergency medical service transport from the field directly to the catheterization laboratory, thereby bypassing the emergency department (ED), may shorten t ... Full text Link to item Cite

Survival of patients receiving a primary prevention implantable cardioverter-defibrillator in clinical practice vs clinical trials.

Journal Article JAMA · January 2, 2013 IMPORTANCE: Randomized clinical trials have shown that implantable cardioverter-defibrillator (ICD) therapy saves lives. Whether the survival of patients who received an ICD in primary prevention clinical trials differs from that of trial-eligible patients ... Full text Link to item Cite

Transport time and care processes for patients transferred with ST-segment-elevation myocardial infarction: the reperfusion in acute myocardial infarction in Carolina emergency rooms experience.

Journal Article Circ Cardiovasc Interv · August 1, 2012 BACKGROUND: For patients with ST-segment elevation myocardial infarction transferred for primary percutaneous coronary intervention, guidelines have called for device activation within 90 minutes of initial presentation. Fewer than 20% of transferred patie ... Full text Link to item Cite

Expansion of a regional ST-segment-elevation myocardial infarction system to an entire state.

Journal Article Circulation · July 10, 2012 BACKGROUND: Despite national guidelines calling for timely coronary artery reperfusion, treatment is often delayed, particularly for patients requiring interhospital transfer. METHODS AND RESULTS: One hundred nineteen North Carolina hospitals developed coo ... Full text Link to item Cite

Serious infection after acute myocardial infarction: incidence, clinical features, and outcomes.

Journal Article JACC Cardiovasc Interv · July 2012 OBJECTIVES: The aim of this study was to address the knowledge gap using the APEX-AMI (Assessment of Pexelizumab in Acute Myocardial Infarction) trial database. We also assessed the association between serious infections and 90-day death or death/myocardia ... Full text Link to item Cite

Drotrecogin alfa (activated) in adults with septic shock.

Journal Article N Engl J Med · May 31, 2012 BACKGROUND: There have been conflicting reports on the efficacy of recombinant human activated protein C, or drotrecogin alfa (activated) (DrotAA), for the treatment of patients with septic shock. METHODS: In this randomized, double-blind, placebo-controll ... Full text Link to item Cite

Trends in use of implantable cardioverter-defibrillator therapy among patients hospitalized for heart failure: have the previously observed sex and racial disparities changed over time?

Journal Article Circulation · March 6, 2012 BACKGROUND: Prior studies have demonstrated low use of implantable cardioverter defibrillators (ICDs) as primary prevention, particularly among women and blacks. The degree to which the overall use of ICD therapy and disparities in use have changed is uncl ... Full text Link to item Cite

Patterns of left ventricular remodeling in patients with Duchenne Muscular Dystrophy: a cardiac MRI study of ventricular geometry, global function, and strain.

Journal Article Int J Cardiovasc Imaging · January 2012 The cardiac disease ubiquitously associated in Duchenne Muscular Dystrophy (DMD) has traditionally been considered a progressive dilated cardiomyopathy (DCM). However, left ventricular (LV) dilatation as measured with cardiac MRI has not been a consistent ... Full text Link to item Cite

Insights on the robust variance estimator under recurrent-events model.

Journal Article Biometrics · December 2011 Recurrent events are common in medical research for subjects who are followed for the duration of a study. For example, cardiovascular patients with an implantable cardioverter defibrillator (ICD) experience recurrent arrhythmic events that are terminated ... Full text Link to item Cite

Effects of steroids and angiotensin converting enzyme inhibition on circumferential strain in boys with Duchenne muscular dystrophy: a cross-sectional and longitudinal study utilizing cardiovascular magnetic resonance.

Journal Article J Cardiovasc Magn Reson · October 19, 2011 BACKGROUND: Steroid use has prolonged ambulation in Duchenne muscular dystrophy (DMD) and combined with advances in respiratory care overall management has improved such that cardiac manifestations have become the major cause of death. Unfortunately, there ... Full text Link to item Cite

Apixaban versus warfarin in patients with atrial fibrillation.

Journal Article N Engl J Med · September 15, 2011 BACKGROUND: Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar ... Full text Link to item Cite

Diagnostic performance of computed tomography angiography for differentiating ischemic vs nonischemic cardiomyopathy.

Journal Article J Nucl Cardiol · May 2011 BACKGROUND: Although the use of computed tomography angiography (CTA) is considered "appropriate" to distinguish ischemic vs nonischemic etiology in patients with cardiomyopathy under the current clinical practice guideline, the evidence to support this ha ... Full text Link to item Cite

Presence of mechanical dyssynchrony in Duchenne muscular dystrophy.

Journal Article J Cardiovasc Magn Reson · February 2, 2011 BACKGROUND: Cardiac dysfunction in boys with Duchenne muscular dystrophy (DMD) is a leading cause of death. Cardiac resynchronization therapy (CRT) has been shown to dramatically decrease mortality in eligible adult population with congestive heart failure ... Full text Link to item Cite

Comparison of magnetic resonance feature tracking for strain calculation with harmonic phase imaging analysis.

Journal Article JACC Cardiovasc Imaging · February 2010 OBJECTIVES: To compare a steady-state free precession cine sequence-based technique (feature tracking [FT]) to tagged harmonic phase (HARP) analysis for peak average circumferential myocardial strain (epsilon(cc)) analysis in a large and heterogeneous popu ... Full text Link to item Cite

Transfusion and mortality in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention.

Journal Article Eur Heart J · November 2009 AIMS: Red blood cell transfusion is associated with increased mortality among patients with acute coronary syndromes, but little is known about the consequences of transfusion in a contemporary setting of ST-segment elevation myocardial infarction. We desc ... Full text Link to item Cite

Azimilide reduces emergency department visits and hospitalizations in patients with an implantable cardioverter-defibrillator in a placebo-controlled clinical trial.

Journal Article J Am Coll Cardiol · September 23, 2008 OBJECTIVES: The goal of this study was to determine whether azimilide, as compared with placebo, will reduce the number of emergency department (ED) visits and hospitalizations caused by arrhythmias or cardiac events in patients with an implantable cardiov ... Full text Link to item Cite

Zoledronate, fractures, and mortality after hip fracture [3]

Journal Article New England Journal of Medicine · February 28, 2008 Cite

Zoledronate, fractures, and mortality after hip fracture [4]

Journal Article New England Journal of Medicine · February 28, 2008 Cite

Zoledronate, fractures, and mortality after hip fracture.

Journal Article N Engl J Med · February 28, 2008 Link to item Cite

Failure of investigator adherence to electrocardiographic entry criteria is frequent and influences clinical outcomes: lessons from APEX-AMI.

Journal Article Eur Heart J · December 2007 AIMS: To examine the extent and impact on clinical outcomes of adherence to electrocardiogram (ECG) entry criteria in ST-elevation myocardial infarction patients in the assessment of pexelizumab in acute myocardial infarction (APEX-AMI) trial. METHODS AND ... Full text Link to item Cite

Electrical storm in patients with an implantable defibrillator: incidence, features, and preventive therapy: insights from a randomized trial.

Journal Article Eur Heart J · December 2006 AIMS: The purpose of this study was to assess the incidence, features, and clinical sequelae of 'electrical storm' (ES). METHODS AND RESULTS: This study is a prospectively designed secondary analysis of SHIELD; a randomized trial of azimilide for suppressi ... Full text Link to item Cite

Cumulative experience of azimilide-associated torsades de pointes ventricular tachycardia in the 19 clinical studies comprising the azimilide database.

Journal Article J Am Coll Cardiol · August 1, 2006 OBJECTIVES: The purpose of this study was to assess the incidence, temporal characteristics, and risk factors associated with azimilide-associated torsades de pointes (TdP) ventricular tachycardia. BACKGROUND: Azimilide dihydrochloride is a class III antia ... Full text Link to item Cite

Design of the SHock Inhibition Evaluation with Azimilide (SHIELD) study: a novel method to assess antiarrhythmic drug effect in patients with an implantable cardioverter-defibrillator.

Journal Article Am J Cardiol · January 15, 2005 This report presents the rationale and study design details of the SHock Inhibition Evaluation with Azimilide study, which is recruiting 624 patients with implantable cardioverter-defibrillators (ICDs) who are at risk for life-threatening ventricular arrhy ... Full text Link to item Cite

Placebo-controlled, randomized clinical trial of azimilide for prevention of ventricular tachyarrhythmias in patients with an implantable cardioverter defibrillator.

Journal Article Circulation · December 14, 2004 BACKGROUND: Although implanted cardioverter defibrillators (ICDs) effectively treat sustained ventricular tachyarrhythmias, up to 50% of ICD recipients eventually require concomitant antiarrhythmic drug therapy to prevent symptomatic arrhythmia recurrences ... Full text Link to item Cite

The efficacy of azimilide in the treatment of atrial fibrillation in the presence of left ventricular systolic dysfunction: results from the Azimilide Postinfarct Survival Evaluation (ALIVE) trial.

Journal Article J Am Coll Cardiol · April 7, 2004 OBJECTIVES: The purpose of this study was to assess the effect of oral azimilide dihydrochloride (AZ) 100 mg versus placebo on the onset, termination, and prevalence of atrial fibrillation (AF) in a subpopulation of patients in the Azimilide Postinfarct Su ... Full text Link to item Cite

Mortality in patients after a recent myocardial infarction: a randomized, placebo-controlled trial of azimilide using heart rate variability for risk stratification.

Journal Article Circulation · March 2, 2004 BACKGROUND: Depressed left ventricular function (LVF) and low heart rate variability (HRV) identify patients at risk of increased mortality after myocardial infarction (MI). Azimilide, a novel class III antiarrhythmic drug, was investigated for its effects ... Full text Link to item Cite

Azimilide decreases recurrent ventricular tachyarrhythmias in patients with implantable cardioverter defibrillators.

Journal Article J Am Coll Cardiol · January 7, 2004 OBJECTIVES: This study evaluated the effects of azimilide dihydrochloride (AZ) on anti-tachycardia pacing (ATP) and shock-terminated events in patients with implantable cardioverter defibrillators (ICDs). BACKGROUND: Animal studies have shown the effective ... Full text Link to item Cite

Proarrhythmia of azimilide and other class III antiarrhythmic agents in the adrenergically stimulated rabbit.

Journal Article Proc Soc Exp Biol Med · February 2000 The ventricular proarrhythmic actions of five class III antiarrhythmic agents were compared in the Carlsson rabbit model. In adrenergically stimulated anesthetized rabbits, azimilide, clofilium, dofetilide, sematilide, and d,l-sotalol caused premature vent ... Full text Link to item Cite

Azimilide pharmacokinetics and pharmacodynamics upon multiple oral dosing.

Journal Article Biopharm Drug Dispos · March 1999 This study assessed steady-state azimilide pharmacokinetics and pharmacodynamics in 119 healthy male and female volunteers. Parallel groups of 18-40-year-old subjects received doses of 35, 100, 150 or 200 mg day(-1) for up to 14 days, with 1, 2 or 3 days o ... Full text Link to item Cite

Azimilide pharmacokinetics and pharmacodynamics upon multiple oral dosing

Journal Article Clinical Pharmacology and Therapeutics · December 1, 1997 Azimilide is a new, novel Class III antiarrhythmic drug that blocks slow and fast K+ channels. To assess dose proportionality, parallel groups of healthy subjects (ages 18 - 40 y) were administered drug for 14 days, with up to 3 days of loading. Doses were ... Cite

Application of a continuous-time Markov chain to a preclinical study

Journal Article Drug Information Journal · 1997 A continuous-time Markov model is used to analyze electrocardiogram data obtained from a preclinical study in rabbits of five antiarrhythmic compounds. The preclinical protocol and data are introduced briefly. Some theoretical background for finite-state c ... Cite

Application of boundary calculation methodologies to group sequential testing in general parametric models

Journal Article Communications in Statistics - Theory and Methods · January 1, 1997 For clinical trials with interim analyses, there have been methodologies and software to calculate boundaries for comparing binomial, normal, and survival data from two treatment groups. Jennison & Turnbull (1991) extended Pocock (1977) and O'Brien-Fleming ... Full text Cite

Comparison of azimilide dihydrochloride (NE-10064) and selected class III antiarrhythmic agents in a rabbit model of proarrhythmia

Journal Article FASEB Journal · December 1, 1996 Prolongation of the cardiac refractoriness by class III antiarrhythmics has been associated with proarrhythmia. Azimilide dinydrochloride (AZ), was compared to clolilium, dofetilide, sematilide and d./-sotalol in a rabbit proarrhythmia model. Rabbits (n=12 ... Cite

MCA flow asymmetry is a marker for cerebrovascular disease.

Journal Article Neurol Res · April 1996 Utilizing the UIC Vascular Laboratory Registry, we retrospectively analysed the significance of side to side middle cerebral artery (MCA) flow velocity differences. Side to side differences > 15 percent measured by transcranial Doppler were considered asym ... Full text Link to item Cite

On the misspecification of a lognormal distribution

Journal Article Communications in Statistics - Theory and Methods · January 1, 1994 The effects of assuming a normal distribution when in fact the data are lognormal are examined with respect to confidence intervals based on the usual t-statistic. The nature and degree of coverage probabilities which can be overstated or understated are e ... Full text Cite

Some Aspects of Maximum Likelihood Estimation of Multistage Cancer Dose-Response Models with Application

Journal Article Communications in Statistics - Theory and Methods · January 1, 1993 Quantitative cancer dose-response models play an important role in cancer risk assessment. They also play a role in regulatory processes associated with potential occupational or environmental exposures. The multistage model is currently the most widely us ... Full text Cite

Comparing time trends in a two-arm longitudinal study with an ordinal categorical response

Journal Article Communications in Statistics - Theory and Methods · January 1, 1993 A within-subject monotonicity index is proposed to summarize the followup for each subject in a longitudinal study where the response is required to be only ordinal. The individual measures can be weighted to detect different trend behaviors of interest. A ... Full text Cite

Some pitfalls of tests of separate families of hypotheses: Normality vs. lognormality

Journal Article Communications in Statistics - Theory and Methods · January 1, 1991 It is often desirable to test non-nested hypotheses. Cox (1961, 1962) proposed forming a log-likelihood ratio from their maxima and then comparing this value to its expected value under the null hypothesis. Pitfalls exists when we apply Cox's test to the s ... Full text Cite