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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00806988
First received: December 10, 2008
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Mitral Valve Insufficiency
Coronary Artery Disease
Procedure: Mitral Valve Repair
Procedure: CABG
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surgical Interventions for Moderate Ischemic Mitral Regurgitation

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Degree of left ventricular remodeling, as assessed by left ventricular end systolic volume index (LVESVI) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]

Enrollment: 301
Study Start Date: December 2008
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mitral Valve Repair
Participants will undergo CABG and a mitral valve repair procedure.
Procedure: Mitral Valve Repair

Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:

  1. All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.
  2. The heart will be arrested with cardioplegia.
  3. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.
Procedure: CABG
CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.
Active Comparator: CABG
Participants will undergo CABG.
Procedure: CABG
CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806988

  Hide Study Locations
Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30383
Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
NIH Heart Center at Suburban Hospital
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Missouri
Washington University
St Louis, Missouri, United States, 63110
United States, New York
Montefiore Einstein Heart Center
Bronx, New York, United States, 10467
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Mission Hospital
Asheville, North Carolina, United States, 28801
Duke University
Durham, North Carolina, United States, 27710
East Carolina Heart Institute
Greenville, North Carolina, United States, 27834
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor Research Institute
Plano, Texas, United States, 75093
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Inova Heart and Vascular Institute
Falls Church, Virginia, United States, 22042
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G2B7
Canada, Ontario
University of Toronto Sunnybrook Health Science Centre
Toronto, Ontario, Canada, M4N 3M5
University of Toronto, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Saint Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada, QC H4J 1C5
Canada
Quebec Heart Institute/Laval Hopital
Quebec, Canada, H7M 3L9
Denmark
Aarhus University Hospital
Aarhus N, Denmark, 8200
Sponsors and Collaborators
Mount Sinai School of Medicine
Canadian Institutes of Health Research (CIHR)
Investigators
Study Chair: Timothy Gardner, MD Christiana Care Health Services
Study Chair: Patrick O'Gara, MD Brigham and Women's Hospital
Principal Investigator: Annetine Gelijns, Ph.D. Mount Sinai School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00806988     History of Changes
Obsolete Identifiers: NCT00838786
Other Study ID Numbers: GCO 08-1078-00001, U01HL088942, U01 HL088942-01-1, 594
Study First Received: December 10, 2008
Last Updated: April 4, 2014
Health Authority: United States: Federal Government
Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee

Keywords provided by Mount Sinai School of Medicine:
Ischemic Mitral Regurgitation
Mitral Valve Regurgitation

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

ClinicalTrials.gov processed this record on September 14, 2014