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

Not Applicable

Completed

Conditions: Coronary Artery Disease
Mitral Valve Insufficiency

Interventions: Procedure: Mitral Valve Repair
Procedure: CABG

Registration Number: NCT00806988

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary: 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.

Detailed Description: CAD occurs when the arteries that supply blood to the heart become blocked as a result of plaque buildup. In severe cases, CAD can cause chest pain, shortness of breath, and heart attack. CABG is one treatment option for people with CAD. During a CABG procedure, a healthy artery or vein from another part of the body is connected to the blocked coronary artery. Blood flow is then routed around the blockage to the heart.

After a heart attack, some people may have a leak in the mitral valve of the heart. This condition is known as ischemic mitral regurgitation (IMR) and is associated with poor health outcomes, including worsening heart failure. In people with severe mitral valve leakage, the CABG procedure and a mitral valve repair procedure are routinely performed together; however, in people with only moderate valve leakage, there is no consensus in the medical community as to whether the mitral valve repair procedure is beneficial at the time of CABG. The purpose of this study is to determine whether people with moderate mitral valve regurgitation should undergo a mitral valve repair procedure in addition to CABG or undergo CABG alone.

This study will enroll people with CAD who require a CABG procedure and have moderate mitral regurgitation. At a baseline study visit, participants will undergo a physical examination; blood collection; neurocognitive tests; and questionnaires regarding medical history, medication history, and quality of life. In the operating room, participants will be randomly assigned to undergo either CABG surgery and the mitral valve repair procedure or only CABG surgery. Blood, urine, and tissue samples may be collected from participants after the surgery; this is optional and will only be done with prior approval from participants. All participants will attend study visits at Months 6, 12, and 24. At each visit, participants will take part in a medication history review, a physical examination, an echocardiogram, a cardiopulmonary exercise test, neurocognitive tests, and quality of life surveys.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 301

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mitral Valve Repair	Mitral Valve Repair	Participants will undergo CABG and a mitral valve repair procedure.
Mitral Valve Repair	CABG	Participants will undergo CABG and a mitral valve repair procedure.
CABG	CABG	Participants will undergo CABG.

Primary Outcome Measures

Name	Time	Method
Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)	Measured at Month 12

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Event, Including Death, Stroke, Worsening Heart Failure (+1 New York Heart Association [NYHA] Class), Congestive Heart Failure Hospitalization, or Mitral Valve Re-intervention	Measured at Month 24

Trial Locations

Locations (27): Washington University
🇺🇸
St Louis, Missouri, United States
Baystate Medical Center
🇺🇸
Springfield, Massachusetts, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
Montefiore Einstein Heart Center
🇺🇸
Bronx, New York, United States
Montreal Heart Institute
🇨🇦
Montreal, Quebec, Canada
Quebec Heart Institute/Laval Hopital
🇨🇦
Quebec, Canada
Hôpital du Sacré-Coeur de Montréal
🇨🇦
Montreal, Quebec, Canada
Aarhus University Hospital
🇩🇰
Aarhus N, Denmark
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
University of Alberta Hospital
🇨🇦
Edmonton, Alberta, Canada
Baylor Research Institute
🇺🇸
Plano, Texas, United States
Inova Heart and Vascular Institute
🇺🇸
Falls Church, Virginia, United States
University of Southern California
🇺🇸
Los Angeles, California, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Wellstar Kennestone Hospital
🇺🇸
Marietta, Georgia, United States
University of Maryland
🇺🇸
Baltimore, Maryland, 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
NIH Heart Center at Suburban Hospital
🇺🇸
Bethesda, Maryland, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
University of Toronto, Toronto General Hospital
🇨🇦
Toronto, Ontario, Canada
Ohio State University
🇺🇸
Columbus, Ohio, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
University of Toronto Sunnybrook Health Science Centre
🇨🇦
Toronto, Ontario, Canada
Saint Michael's Hospital
🇨🇦
Toronto, Ontario, Canada