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Multicenter Myocardial Viability Trial

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2006 by CHI St. Luke's Health, Texas.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00661232
First Posted: April 18, 2008
Last Update Posted: April 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic - MITG
Information provided by:
CHI St. Luke's Health, Texas
  Purpose
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.

Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An International, Multicenter Trial Assessing Myocardial Viability With Contrast - Enhanced Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by CHI St. Luke's Health, Texas:

Primary Outcome Measures:
  • 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 ]

Enrollment: 235
Study Start Date: August 2003
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients were recruited from 9 institutions on 3 different continent. All patients recruited for the study had a history of angiographically documented chronic coronary artery disease and resting wall motion abnormalities, and were scheduled for cardiac revascularization (coronary artery bypass surgery or percutaneous intervention).
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661232


Locations
United States, Texas
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
St. Luke's Episcopal Location
Houston, Texas, United States, 77030
Belgium
Cliniques Universitaires St. Luc
Brussels, Belgium, B-1200
Denmark
Skejby University Hospital
Aarhus N, Denmark, 8200
Greece
Hygeia Hospital
Maroussi, Greece, 15123
Thailand
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
United Kingdom
Cardiac MRI Unit
Leeds, United Kingdom, LS1 3EX
Sponsors and Collaborators
CHI St. Luke's Health, Texas
Medtronic - MITG
Investigators
Principal Investigator: Scott D Flamm, M.D. CHI St. Luke's Health, Texas
  More Information

Responsible Party: Scott D. Flamm, M.D., St. Luke's Episcopal Hospital
ClinicalTrials.gov Identifier: NCT00661232     History of Changes
Other Study ID Numbers: 1102-02-777
NDA# 20-937
IND# 66,506
First Submitted: April 16, 2008
First Posted: April 18, 2008
Last Update Posted: April 18, 2008
Last Verified: February 2006

Keywords provided by CHI St. Luke's Health, Texas:
Myocardial Viability
Delayed Enhancement Magnetic Resonance Imaging
Functional Recovery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases