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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
  Purpose
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

Condition Intervention Phase
Subacute/Chronic Myocardial Infarction Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Intraindividual Comparison of the Diagnostic Accuracy Using Gadobutrol (Gadovist®) Versus Gadobenat Dimeglumin (Multihance®) for Delayed Enhancement MRI of Myocardial Infarction.

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Efficacy (contrast-to-noise ratio)

Estimated Enrollment: 20
Study Start Date: August 2012
Study Completion Date: June 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gadobutrol
first session gadobutrol second session gadobenate dimeglumin
Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)
Other (Diagnostic)
Experimental: Demeglumin
first session gadobenate dimeglumin second session gadobutrol
Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)
Other (Diagnostic)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655290


Locations
Germany
Institut für Radiologie - Klinikum Rechts der Isar
Munic, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
  More Information

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01655290     History of Changes
Other Study ID Numbers: GAD-1140-WIL-0020-I
First Submitted: July 30, 2012
First Posted: August 1, 2012
Last Update Posted: March 17, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases


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