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Clinical Trials/NCT00661232
NCT00661232
Completed
Not 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 enrollmentAugust 11, 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
CHI St. Luke's Health, Texas
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).
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 11, 2003
End Date
May 15, 2011
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
CHI St. Luke's Health, Texas
Responsible Party
Principal Investigator
Principal Investigator

Scott D. Flamm, M.D.

Principal Investigator

CHI St. Luke's Health, Texas

Eligibility Criteria

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

Study Sites (7)

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