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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

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ClinicalTrials.gov Identifier: NCT00806988
Recruitment Status : Completed
First Posted : December 11, 2008
Results First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Alan Moskowitz, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE December 10, 2008
First Posted Date  ICMJE December 11, 2008
Results First Submitted Date  ICMJE April 11, 2017
Results First Posted Date  ICMJE June 26, 2017
Last Update Posted Date June 26, 2017
Study Start Date  ICMJE December 2008
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI) [ Time Frame: Measured at Month 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 10, 2008)
Degree of left ventricular remodeling, as assessed by left ventricular end systolic volume index (LVESVI) [ Time Frame: Measured at Month 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Surgical Interventions for Moderate Ischemic Mitral Regurgitation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Mitral Valve Insufficiency
  • Coronary Artery Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Mitral Valve Repair
    Participants will undergo CABG and a mitral valve repair procedure.
    Interventions:
    • Procedure: Mitral Valve Repair
    • Procedure: CABG
  • Active Comparator: CABG
    Participants will undergo CABG.
    Intervention: Procedure: CABG
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2013)
301
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2008)
300
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00806988
Other Study ID Numbers  ICMJE GCO 08-1078-00003
U01HL088942 ( U.S. NIH Grant/Contract )
594 ( Other Identifier: Ct Surgery Network Research Group )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alan Moskowitz, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Canadian Institutes of Health Research (CIHR)
  • National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
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. Icahn School of Medicine at Mount Sinai
Principal Investigator: Alan Moskowitz, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date April 2017

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