We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01655290
Recruitment Status : Completed
First Posted : August 1, 2012
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):

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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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.
Study Start Date : August 2012
Primary Completion Date : May 2013
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Gadobutrol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Posted: August 1, 2012    Key Record Dates
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