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CompletedNCT01655290GadovitUpdated Oct 22, 2020

Comparison of Gadobutrol and Gadobenate Dimeglumin for Delayed Enhancement Cardiac MRI

A Phase 2 interventional study of Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin) in Subacute/Chronic Myocardial Infarction, sponsored by Technical University of Munich. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-10-22.

Sponsored by Technical University of Munich · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Subacute/Chronic Myocardial Infarction
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 20 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Gadobutrol

    first session gadobutrol second session gadobenate dimeglumin

    Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)

  • Experimental
    Demeglumin

    first session gadobenate dimeglumin second session gadobutrol

    Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)

Interventions

  • OtherGadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)

    Other (Diagnostic)

06

What researchers measure

Primary outcomes

  1. Efficacy (contrast-to-noise ratio)

07

Study locations

1 site
  • Institut für Radiologie - Klinikum Rechts der Isar
    Munic, Bavaria 81675, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01655290
Lead sponsor
Technical University of Munich
Responsible party
Sponsor
First posted
Aug 1, 2012
Start date
Aug 2012
Primary completion
May 2013
Completion
Jun 2014
Last update
Oct 22, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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