Trial Condition(s):
Myocardial Infarction
Depiction of delayed enhancement in patients with documented myocardial infarction
Bayer Identifier:
91230
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The purpose of this study is to determine the dose of drug which is most effective in the delineation of dead heart muscle.
Inclusion Criteria
- At least 8 weeks post-documented myocardial infarction (heart attack)
Exclusion Criteria
- History of radiation therapy to the chest - Clinically unstable - Any contraindication for MRI
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Allegheny General Hospital Pittsburgh, United States, 15212-4772 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pennsylvania State University College of Medicine Hershey, United States, 17033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Forsyth Radiologcial Associates, PA Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oklahoma Heart Institute Tulsa, United States, 74133 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of California-San Diego Medical Center San Diego, United States, 92103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oregon Health and Science University Portland, United States, 97239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Diagnóstico Dr. Enrique Rossi Buenos Aires, Argentina, C1428BKN | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Multicenter, single-blind, randomized, intraindividual study of the safety and efficacy of Magnevist Gadopentetate dimeglumine (Magnevist® Injection) at 0.1 and 0.2 mmol/kg for the depiction of delayed enhancement in patients with documented myocardial infarction
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Randomized
Blinding:
Single Blind
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Quantitative measurement of the total area of delayed enhancementTimeframe: 30 min post injection
Secondary Outcome
- Quantitative measures of area of delayed enhancement and signal intensitiesTimeframe: At 5, 10 and 20 minutes post injection
- Semiquantitative measures of area of delayed enhancementTimeframe: At 5, 10, 20 and 30 minutes post injection
- Presence of delayed enhancementTimeframe: At 5,10 and 20 minutes post injection
- Wall motion endpointsTimeframe: Pre-injection
- SafetyTimeframe: From baseline to 24h follow-up of second imaging
Additional Information
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