Document Detail

Safety of gadoversetamide in patients with acute and chronic myocardial infarction.
MedLine Citation:
PMID:  19025944     Owner:  NLM     Status:  MEDLINE    
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.
S Huber; R Muthupillai; B Cheong; J H Wible; D Shah; P Woodard; F Grothues; H Mahrholdt; C E Rochitte; O Masoli; R J Kim; C M Schwaiger; A Fuisz; C Kramer; A C van Rossum; R Biederman; M Lombardi; E Martin; R Kevorkian; S D Flamm
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of magnetic resonance imaging : JMRI     Volume:  28     ISSN:  1053-1807     ISO Abbreviation:  J Magn Reson Imaging     Publication Date:  2008 Dec 
Date Detail:
Created Date:  2008-12-01     Completed Date:  2009-02-10     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9105850     Medline TA:  J Magn Reson Imaging     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1368-78     Citation Subset:  IM    
Copyright Information:
(c) 2008 Wiley-Liss, Inc.
Advanced Cardiovascular Imaging, Department of Radiology, MC 2-270, St. Luke's Episcopal Hospital and the Texas Heart Institute, 6720 Bertner Ave., Houston, Texas, 77030, USA.
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MeSH Terms
Acute Disease
Aged, 80 and over
Analysis of Variance
Chi-Square Distribution
Chronic Disease
Contrast Media / administration & dosage,  adverse effects
Middle Aged
Myocardial Infarction / diagnosis*
Organometallic Compounds / administration & dosage,  adverse effects,  diagnostic use*
Reg. No./Substance:
0/Contrast Media; 0/Organometallic Compounds; 0/gadoversetamide

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