Comparison of Gadobutrol and Gadobenate Dimeglumin for Delayed Enhancement Cardiac MRI

NCT ID: NCT01655290

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Subacute/Chronic Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Gadobutrol

first session gadobutrol second session gadobenate dimeglumin

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Other (Diagnostic)

Demeglumin

first session gadobenate dimeglumin second session gadobutrol

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Other (Diagnostic)

Interventions

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

Other (Diagnostic)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut für Radiologie - Klinikum Rechts der Isar

Munich, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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GAD-1140-WIL-0020-I

Identifier Type: -

Identifier Source: org_study_id

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