Comparison of Gadobutrol and Gadobenate Dimeglumin for Delayed Enhancement Cardiac MRI

Phase 2

Completed

• Conditions: Subacute/Chronic Myocardial Infarction

• 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

Study Timeline

• Study First Submitted: 2012-07-30
• Study First Submitted QC: 2012-07-30
• Study Start: 2012-08
• Study First Posted: 2012-08-01
• Primary Completion: 2013-05
• Study Completion: 2014-06
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

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

Primary Outcome Measures

Name	Time	Method
Efficacy (contrast-to-noise ratio)

Trial Locations

Locations (1)

Institut für Radiologie - Klinikum Rechts der Isar; 🇩🇪 Munic, Bavaria, Germany