Comparison of Gadobutrol and Gadobenate Dimeglumin for Delayed Enhancement Cardiac MRI
Phase 2
Completed
- Conditions
- Subacute/Chronic Myocardial Infarction
- Interventions
- Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)
- Registration Number
- NCT01655290
- Lead Sponsor
- Technical University of Munich
- Brief Summary
This study aims at evaluating the diagnostic efficacy of Gadobutrol versus Gadobenate dimeglumine at similar dose of 0.1mmol/kg for assessment of myocardial infarction by delayed enhancement cardiac Magnetic Resonance Imaging
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Diagnosis of myocardial infarction
- Age ≥ 18 years and ≤ 80 years
- Informed consent
- Male patients as well as female patients using contraceptives
Exclusion Criteria
- Patients with a heart pacemaker, with magnetic material or other magnetic implants.
- Renal failure (GFR <30ml/min)
- Patients with known allergy to a Gadolinium-containing contrast agent
- Drugs or alcohol addiction, dementia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Gadobutrol Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin) first session gadobutrol second session gadobenate dimeglumin Demeglumin Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin) first session gadobenate dimeglumin second session gadobutrol
- Primary Outcome Measures
Name Time Method Efficacy (contrast-to-noise ratio)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institut für Radiologie - Klinikum Rechts der Isar
🇩🇪Munic, Bavaria, Germany