Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction

Phase 2

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882)

• Registration Number: NCT00310544
• Lead Sponsor: Bayer

Brief Summary

The purpose of this study is to determine the dose of drug which is most effective in the delineation of dead heart muscle.

Detailed Description

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-31
• Study First Submitted QC: 2006-04-03
• Study First Posted: 2006-04-04
• Study Completion: 2006-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-11
• Last Update Posted: 2014-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• At least 8 weeks post-documented myocardial infarction (heart attack)

Exclusion Criteria

• History of radiation therapy to the chest
• Clinically unstable
• Any contraindication for MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 2	Magnevist (Gadopentetate dimeglumine, BAY86-4882)	-
Arm 1	Magnevist (Gadopentetate dimeglumine, BAY86-4882)	-

Primary Outcome Measures

Name	Time	Method
Quantitative measurement of the total area of delayed enhancement	30 min post injection

Secondary Outcome Measures

Name	Time	Method
Presence of delayed enhancement	At 5,10 and 20 minutes post injection
Wall motion endpoints	Pre-injection
Safety	From baseline to 24h follow-up of second imaging
Quantitative measures of area of delayed enhancement and signal intensities	At 5, 10 and 20 minutes post injection
Semiquantitative measures of area of delayed enhancement	At 5, 10, 20 and 30 minutes post injection