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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01655290
First Posted: August 1, 2012
Last Update Posted: March 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Technische Universität München
July 30, 2012
August 1, 2012
March 17, 2016
August 2012
May 2013   (Final data collection date for primary outcome measure)
Efficacy (contrast-to-noise ratio)
Same as current
Complete list of historical versions of study NCT01655290 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Comparison of Gadobutrol and Gadobenate Dimeglumin for Delayed Enhancement Cardiac MRI
Intraindividual Comparison of the Diagnostic Accuracy Using Gadobutrol (Gadovist®) Versus Gadobenat Dimeglumin (Multihance®) for Delayed Enhancement MRI of Myocardial Infarction.
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Subacute/Chronic Myocardial Infarction
Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)
Other (Diagnostic)
  • Experimental: Gadobutrol
    first session gadobutrol second session gadobenate dimeglumin
    Intervention: Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)
  • Experimental: Demeglumin
    first session gadobenate dimeglumin second session gadobutrol
    Intervention: Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2014
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01655290
GAD-1140-WIL-0020-I
No
Not Provided
Not Provided
Technische Universität München
Technische Universität München
Not Provided
Not Provided
Technische Universität München
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP