Comparison of Gadobutrol and Gadobenate Dimeglumin for Delayed Enhancement Cardiac MRI (Gadovit)

Technical University of Munich

Status and phase: Completed; Phase 2

Conditions: Subacute/Chronic Myocardial Infarction

Treatments: Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)

Study type: Interventional

Funder types: Other

Identifiers

NCT01655290

GAD-1140-WIL-0020-I

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Gadobutrol

Experimental group

Description:

first session gadobutrol second session gadobenate dimeglumin

Treatment:

Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)

Demeglumin

Experimental group

Description:

first session gadobenate dimeglumin second session gadobutrol

Treatment:

Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)