Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction

Bayer

Status and phase: Completed; Phase 2

Conditions: Myocardial Infarction

Treatments: Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00310544

91230

DE-03899

306947

Details and patient eligibility

About

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

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

73 participants in 2 patient groups

Arm 2

Experimental group

Treatment:

Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882)

Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882)

Arm 1

Experimental group

Treatment:

Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882)

Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882)