Overview

This trial is active, not recruiting.

Condition coronary artery disease
Sponsor St. Luke's Medical Center, Texas
Collaborator Covidien
Start date August 2003
End date October 2008
Trial size 235 participants
Trial identifier NCT00661232, 1102-02-777, IND# 66,506, NDA# 20-937

Summary

The purpose of this study is to test the hypothesis of whether contrast enhanced Magnetic Resonance Imaging can be used to predict improvement of the wall motion in regions of the heart with abnormal movement following bypass surgery or percutaneous angioplasty in various institutions across three continents.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
To examine whether the extent of irreversible myocardial injury as assessed by Delayed Enhancement Magnetic Resonance Imaging can predict the extent of functional recovery after revascularization in patients with chronic coronary artery disease (CAD).
time frame: 36 months

Eligibility Criteria

Male or female participants from 21 years up to 85 years old.

Inclusion Criteria: - Age: > 21 years and < 85 years - Sinus rhythm - Weight < 120 kg - LVEF > 30% - Wall motion abnormality on Echo. or LV-gram - Scheduled for revascularization - Angioplasty/Stent or CABG - within 30 days Exclusion Criteria: - Resting heart rate > 100 bpm - Frequent atrial or ventricular ectopy - Severe aortic stenosis or HOCM - Unstable angina - Myocardial infarction within 14 days - Active congestive heart failure - Pregnancy - Known allergy to gadolinium - Contraindication to MRI

Additional Information

Official title An International, Multicenter Trial Assessing Myocardial Viability With Contrast - Enhanced Magnetic Resonance Imaging
Principal investigator Scott D Flamm, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in April 2008.
Information provided to ClinicalTrials.gov by St. Luke's Medical Center, Texas.