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NCT00661232 Clinical Trial

Multicenter Myocardial Viability Trial

Coronary Artery Disease Clinical Trial

Official title:
An International, Multicenter Trial Assessing Myocardial Viability With Contrast - Enhanced Magnetic Resonance Imaging

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00661232
Other study ID # 1102-02-777
Secondary ID NDA# 20-937IND#
Status Completed
Phase
First received
Last updated
Start date August 11, 2003
Est. completion date May 15, 2011

Study information
Verified date November 2020
Source CHI St. Luke's Health, Texas
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 235
Est. completion date May 15, 2011
Est. primary completion date January 14, 2011
Accepts healthy volunteers No
Gender All
Age group 21 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium Cliniques Universitaires St. Luc Brussels
Denmark Skejby University Hospital Aarhus N
Greece Hygeia Hospital Maroussi
Thailand Siriraj Hospital Bangkoknoi Bangkok
United Kingdom Cardiac MRI Unit Leeds
United States St. Luke's Episcopal Hospital Houston Texas
United States St. Luke's Episcopal Location Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
CHI St. Luke's Health, Texas Medtronic - MITG

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  Greece,  Thailand,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). 36 months
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