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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01655290
First received: July 30, 2012
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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
Estimated Study Completion Date: December 2013
Estimated 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655290

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

No publications provided

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01655290     History of Changes
Other Study ID Numbers: GAD-1140-WIL-0020-I
Study First Received: July 30, 2012
Last Updated: May 15, 2013
Health Authority: Germany: District Government of Upper Bavaria

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

ClinicalTrials.gov processed this record on May 23, 2013