Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.

Journal Article

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies. (J Am Coll Cardiol 2017;▪:▪-▪) © 2017 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Full Text

Duke Authors

Cited Authors

  • Lansky, AJ; Messé, SR; Brickman, AM; Dwyer, M; Bart van der Worp, H; Lazar, RM; Pietras, CG; Abrams, KJ; McFadden, E; Petersen, NH; Browndyke, J; Prendergast, B; Ng, VG; Cutlip, DE; Kapadia, S; Krucoff, MW; Linke, A; Scala Moy, C; Schofer, J; van Es, G-A; Virmani, R; Popma, J; Parides, MK; Kodali, S; Bilello, M; Zivadinov, R; Akar, J; Furie, KL; Gress, D; Voros, S; Moses, J; Greer, D; Forrest, JK; Holmes, D; Kappetein, AP; Mack, M; Baumbach, A

Published Date

  • February 7, 2017

Published In

PubMed ID

  • 28171522

Electronic International Standard Serial Number (EISSN)

  • 1522-9645

International Standard Serial Number (ISSN)

  • 0195-668X

Digital Object Identifier (DOI)

  • 10.1093/eurheartj/ehx037

Language

  • eng