Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting (CABG) Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation

Completed · Not applicable

Conditions studied: Mitral Valve Insufficiency, Coronary Artery Disease

In brief

Coronary artery bypass grafting (CABG) is a procedure that people with coronary artery disease (CAD) may undergo to increase blood flow to the heart. During a CABG procedure, people who have a leak in one of the valves in the heart-the mitral valve-may at the same time undergo a procedure that repairs the valve. This study will evaluate whether people with moderate mitral valve leakage would be better off undergoing CABG plus the mitral valve repair procedure or undergoing CABG alone.

Key facts

Study ID

NCT00806988

Run by

Icahn School of Medicine at Mount Sinai

People needed

301

Starts

2008-12-01

Expected to finish

2015-05-01

Last updated by the study team

2017-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Moderate mitral regurgitation in the judgment of the clinical site echocardiographer, assessed by transthoracic echocardiogram. Assessment of mitral regurgitation will be performed using an integrative method (Zoghbi W. et al. J. American Society of Echocardiography. 2003:16:777-802. see appendix). Quantitative guidelines as proposed would be: ERO between 0.2 cmsq to 0.39 cmsq. If ERO < 0.2, then the degree of mitral regurgitation will be guided by other color Doppler quantitative methods (jet area/left atrial area ratio, vena contracta, supportive criteria in an integrated fashion
• CAD that is amenable to CABG and a clinical indication for revascularization
• Age ≥ 18 years

You may not qualify if…

• Any evidence of structural (chordal or leaflet) mitral valve disease
• Inability to derive ERO and end-systolic volume index (ESVI) by transthoracic echocardiography
• Planned concomitant intra-operative procedures (with the exception of closure of patent foramen ovale [PFO] or atrial septal defect [ASD]or Maze procedure or left atrial appendage excision)
• Prior surgical or percutaneous mitral valve repair
• Contraindication to cardiopulmonary bypass (CPB)
• Clinical signs of cardiogenic shock at the time of surgery
• Treatment with chronic intravenous inotropic therapy at the time of surgery
• Severe, irreversible pulmonary hypertension in the judgment of the investigator
• ST segment elevation myocardial infarction (MI) requiring intervention in the 7 days before surgery
• Congenital heart disease (except PFO or ASD)
• Evidence of cirrhosis or liver synthetic failure
• Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study, in the judgment of the investigator
• Therapy with an investigational intervention at the time of screening, or planning to enroll in an additional investigational intervention study during participation in the study
• Any concurrent disease with a life expectancy of less than 2 years
• Pregnancy at the time of randomization

Where it is running

• University of Southern California — Los Angeles, California, United States
• Emory University — Atlanta, Georgia, United States
• Wellstar Kennestone Hospital — Marietta, Georgia, United States
• University of Maryland — Baltimore, Maryland, United States
• NIH Heart Center at Suburban Hospital — Bethesda, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Montefiore Einstein Heart Center — The Bronx, New York, United States
• Mission Hospital — Asheville, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• East Carolina Heart Institute — Greenville, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Baylor Research Institute — Plano, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Inova Heart and Vascular Institute — Falls Church, Virginia, United States
• University of Alberta Hospital — Edmonton, Alberta, Canada
• University of Toronto Sunnybrook Health Science Centre — Toronto, Ontario, Canada
• Saint Michael's Hospital — Toronto, Ontario, Canada
• University of Toronto, Toronto General Hospital — Toronto, Ontario, Canada
• Montreal Heart Institute — Montreal, Quebec, Canada
• Hôpital du Sacré-Coeur de Montréal — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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