Skip to main content
Journal cover image

Safety of gadoversetamide in patients with acute and chronic myocardial infarction.

Publication ,  Journal Article
Huber, S; Muthupillai, R; Cheong, B; Wible, JH; Shah, D; Woodard, P; Grothues, F; Mahrholdt, H; Rochitte, CE; Masoli, O; Kim, RJ; Fuisz, A ...
Published in: J Magn Reson Imaging
December 2008

PURPOSE: To assess the safety data from two large, multicenter, phase 2 trials on the use of gadoversetamide (OptiMARK, Tyco Healthcare/Mallinckrodt, St. Louis, MO) as a contrast agent in delayed hyperenhancement magnetic resonance imaging (DE-MRI) in patients with acute and chronic myocardial infarction (MI). MATERIALS AND METHODS: The study population from both trials comprised 577 patients who were randomly assigned to one of four dose groups (0.05, 0.1, 0.2, or 0.3 mmol/kg) before undergoing DE-MRI. Safety evaluations included physical and electrocardiographic (ECG) examinations. Vital signs, laboratory values, adverse events (AE), and serious adverse events (SAE) were monitored before and after contrast administration. RESULTS: Of the 577 patients who received gadoversetamide, 124 (21.5%) reported a total of 164 AEs; most were mild (139 AEs; 84.8%) or moderate (25 AEs; 15.2%). ECG-related changes were the most frequent AE. Site investigators judged only eight AEs as likely related to gadoversetamide and only two of the eight as clinically relevant. Further evaluation suggested neither AE was related to gadoversetamide. Two SAEs were reported, but none was judged related to gadoversetamide by the site investigators. CONCLUSION: Gadoversetamide is safe for use in patients with acute or chronic MI up to a dose of 0.3 mmol/kg.

Duke Scholars

Published In

J Magn Reson Imaging

DOI

ISSN

1053-1807

Publication Date

December 2008

Volume

28

Issue

6

Start / End Page

1368 / 1378

Location

United States

Related Subject Headings

  • Organometallic Compounds
  • Nuclear Medicine & Medical Imaging
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Humans
  • Female
  • Electroencephalography
  • Contrast Media
  • Chronic Disease
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Huber, S., Muthupillai, R., Cheong, B., Wible, J. H., Shah, D., Woodard, P., … Flamm, S. D. (2008). Safety of gadoversetamide in patients with acute and chronic myocardial infarction. J Magn Reson Imaging, 28(6), 1368–1378. https://doi.org/10.1002/jmri.21502
Huber, S., R. Muthupillai, B. Cheong, J. H. Wible, D. Shah, P. Woodard, F. Grothues, et al. “Safety of gadoversetamide in patients with acute and chronic myocardial infarction.J Magn Reson Imaging 28, no. 6 (December 2008): 1368–78. https://doi.org/10.1002/jmri.21502.
Huber S, Muthupillai R, Cheong B, Wible JH, Shah D, Woodard P, et al. Safety of gadoversetamide in patients with acute and chronic myocardial infarction. J Magn Reson Imaging. 2008 Dec;28(6):1368–78.
Huber, S., et al. “Safety of gadoversetamide in patients with acute and chronic myocardial infarction.J Magn Reson Imaging, vol. 28, no. 6, Dec. 2008, pp. 1368–78. Pubmed, doi:10.1002/jmri.21502.
Huber S, Muthupillai R, Cheong B, Wible JH, Shah D, Woodard P, Grothues F, Mahrholdt H, Rochitte CE, Masoli O, Kim RJ, Schwaiger CM, Fuisz A, Kramer C, van Rossum AC, Biederman R, Lombardi M, Martin E, Kevorkian R, Flamm SD. Safety of gadoversetamide in patients with acute and chronic myocardial infarction. J Magn Reson Imaging. 2008 Dec;28(6):1368–1378.
Journal cover image

Published In

J Magn Reson Imaging

DOI

ISSN

1053-1807

Publication Date

December 2008

Volume

28

Issue

6

Start / End Page

1368 / 1378

Location

United States

Related Subject Headings

  • Organometallic Compounds
  • Nuclear Medicine & Medical Imaging
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Humans
  • Female
  • Electroencephalography
  • Contrast Media
  • Chronic Disease