Comparison of Gadobutrol and Gadobenate Dimeglumin for Delayed Enhancement Cardiac MRI (Gadovit)
Primary Purpose
Subacute/Chronic Myocardial Infarction
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)
Sponsored by
About this trial
This is an interventional diagnostic trial for Subacute/Chronic Myocardial Infarction
Eligibility Criteria
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
Sites / Locations
- Institut für Radiologie - Klinikum Rechts der Isar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Gadobutrol
Demeglumin
Arm Description
first session gadobutrol second session gadobenate dimeglumin
first session gadobenate dimeglumin second session gadobutrol
Outcomes
Primary Outcome Measures
Efficacy (contrast-to-noise ratio)
Secondary Outcome Measures
Full Information
NCT ID
NCT01655290
First Posted
July 30, 2012
Last Updated
October 20, 2020
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT01655290
Brief Title
Comparison of Gadobutrol and Gadobenate Dimeglumin for Delayed Enhancement Cardiac MRI
Acronym
Gadovit
Official Title
Single Dose Gadobutrol in Comparison to Single Dose Gadobenate Dimeglumine for Magnetic Resonance Imaging of Chronic Myocardial Infarction at 3 Tesla
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacute/Chronic Myocardial Infarction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gadobutrol
Arm Type
Experimental
Arm Description
first session gadobutrol second session gadobenate dimeglumin
Arm Title
Demeglumin
Arm Type
Experimental
Arm Description
first session gadobenate dimeglumin second session gadobutrol
Intervention Type
Other
Intervention Name(s)
Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)
Intervention Description
Other (Diagnostic)
Primary Outcome Measure Information:
Title
Efficacy (contrast-to-noise ratio)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institut für Radiologie - Klinikum Rechts der Isar
City
Munic
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Comparison of Gadobutrol and Gadobenate Dimeglumin for Delayed Enhancement Cardiac MRI
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