Comparison of Gadobutrol and Gadobenate Dimeglumin for Delayed Enhancement Cardiac MRI

Subacute/Chronic Myocardial Infarction Clinical Trial

— Gadovit  

Official title:

Single Dose Gadobutrol in Comparison to Single Dose Gadobenate Dimeglumine for Magnetic Resonance Imaging of Chronic Myocardial Infarction at 3 Tesla

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655290
• Other study ID #: GAD-1140-WIL-0020-I
• Status: Completed
• Phase: Phase 2
• Start date: August 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2020
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Subacute/Chronic Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Germany	Institut für Radiologie - Klinikum Rechts der Isar	Munic	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy (contrast-to-noise ratio)