Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction

Multicenter, Single-blind, Randomized, Intraindividual Study of the Safety and Efficacy of Magnevist Gadopentetate Dimeglumine (Magnevist® Injection) at 0.1 and 0.2 mmol/kg for the Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00310544

Enrollment

Registered

2006-04-04

Start date

2006-03-31

Completion date

2006-09-30

Last updated

2014-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

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.

Interventions

DRUGMagnevist (Gadopentetate dimeglumine, BAY86-4882)

One intravenous injection per period. Period 1 and 2 are separated by 4 to 14 days.period1:Magnevist 0.1 mmol/kg body weightperiod 2: Magnevist 0.2 mmol/kg body weight

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Quantitative measurement of the total area of delayed enhancement	30 min post injection

Secondary

Measure	Time frame
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
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

Countries

Argentina, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026