NCT00661232CompletedNot Applicable
An International, Multicenter Trial Assessing Myocardial Viability With Contrast - Enhanced Magnetic Resonance Imaging
CHI St. Luke's Health, Texas7 sites in 6 countries235 target enrollmentStarted: August 11, 2003Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 235
- Locations
- 7
- Primary Endpoint
- 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).
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Scott D. Flamm, M.D.
Principal Investigator
CHI St. Luke's Health, Texas
Study Sites (7)
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