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

NCT00806988 | Completed Results DMC

• 3 other identifiers: GCO 08-1078-00003U01HL088942594
• Study Type: interventional
• Target: 301
• Locations: 3 countries
• Sites: 27

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.

Conditions

Mitral Valve Insufficiency; Coronary Artery Disease

Keywords

Ischemic Mitral Regurgitation; Mitral Valve Regurgitation

Outcome Measures

Primary Outcomes (1)

• Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)

  Measured at Month 12

Secondary Outcomes (1)

• 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

Study Arms (2)

Mitral Valve Repair

ACTIVE COMPARATOR

Participants will undergo CABG and a mitral valve repair procedure.

Procedure: Mitral Valve Repair; Procedure: CABG

CABG

ACTIVE COMPARATOR

Participants will undergo CABG.

Procedure: CABG

Interventions

Mitral Valve Repair PROCEDURE

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.

Mitral Valve Repair

CABG PROCEDURE

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.

CABG; Mitral Valve Repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (27)

University of Southern California

Los Angeles, California, 90033, United States

Location

Emory University

Atlanta, Georgia, 30383, United States

Location

Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

NIH Heart Center at Suburban Hospital

Bethesda, Maryland, 20892, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Montefiore Einstein Heart Center

The Bronx, New York, 10467, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

East Carolina Heart Institute

Greenville, North Carolina, 27834, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor Research Institute

Plano, Texas, 75093, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

Location

University of Alberta Hospital

Edmonton, Alberta, T6G2B7, Canada

Location

University of Toronto Sunnybrook Health Science Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Saint Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

University of Toronto, Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, QC H4J 1C5, Canada

Location

Quebec Heart Institute/Laval Hopital

Québec, Quebec, H7M 3L9, Canada

Location

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Related Publications (4)

• Smith PK, Puskas JD, Ascheim DD, Voisine P, Gelijns AC, Moskowitz AJ, Hung JW, Parides MK, Ailawadi G, Perrault LP, Acker MA, Argenziano M, Thourani V, Gammie JS, Miller MA, Page P, Overbey JR, Bagiella E, Dagenais F, Blackstone EH, Kron IL, Goldstein DJ, Rose EA, Moquete EG, Jeffries N, Gardner TJ, O'Gara PT, Alexander JH, Michler RE; Cardiothoracic Surgical Trials Network Investigators. Surgical treatment of moderate ischemic mitral regurgitation. N Engl J Med. 2014 Dec 4;371(23):2178-88. doi: 10.1056/NEJMoa1410490. Epub 2014 Nov 18.

  PMID: 25405390 RESULT

• Bertrand PB, Overbey JR, Zeng X, Levine RA, Ailawadi G, Acker MA, Smith PK, Thourani VH, Bagiella E, Miller MA, Gupta L, Mack MJ, Gillinov AM, Giustino G, Moskowitz AJ, Gelijns AC, Bowdish ME, O'Gara PT, Gammie JS, Hung J; Cardiothoracic Surgical Trials Network (CTSN). Progression of Tricuspid Regurgitation After Surgery for Ischemic Mitral Regurgitation. J Am Coll Cardiol. 2021 Feb 16;77(6):713-724. doi: 10.1016/j.jacc.2020.11.066.

  PMID: 33573741 DERIVED

• Capoulade R, Zeng X, Overbey JR, Ailawadi G, Alexander JH, Ascheim D, Bowdish M, Gelijns AC, Grayburn P, Kron IL, Levine RA, Mack MJ, Melnitchouk S, Michler RE, Mullen JC, O'Gara P, Parides MK, Smith P, Voisine P, Hung J; Cardiothoracic Surgical Trials Network (CTSN) Investigators. Impact of Left Ventricular to Mitral Valve Ring Mismatch on Recurrent Ischemic Mitral Regurgitation After Ring Annuloplasty. Circulation. 2016 Oct 25;134(17):1247-1256. doi: 10.1161/CIRCULATIONAHA.115.021014.

  PMID: 27777294 DERIVED

• Michler RE, Smith PK, Parides MK, Ailawadi G, Thourani V, Moskowitz AJ, Acker MA, Hung JW, Chang HL, Perrault LP, Gillinov AM, Argenziano M, Bagiella E, Overbey JR, Moquete EG, Gupta LN, Miller MA, Taddei-Peters WC, Jeffries N, Weisel RD, Rose EA, Gammie JS, DeRose JJ Jr, Puskas JD, Dagenais F, Burks SG, El-Hamamsy I, Milano CA, Atluri P, Voisine P, O'Gara PT, Gelijns AC; CTSN. Two-Year Outcomes of Surgical Treatment of Moderate Ischemic Mitral Regurgitation. N Engl J Med. 2016 May 19;374(20):1932-41. doi: 10.1056/NEJMoa1602003. Epub 2016 Apr 3.

  PMID: 27040451 DERIVED

Related Links

• Click here for the Cardiothoracic Surgical Trials Network Web site.

MeSH Terms

Conditions

Mitral Valve Insufficiency; Coronary Artery Disease

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Valve Annuloplasty; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Results Point of Contact

• Title: Alan Moskowitz, MD
• Organization: Icahn School of Medicine at Mount Sinai

alan.moskowitz@mountsinai.org

212-659-9568

Study Officials

• Timothy Gardner, MD

  Christiana Care Health Services

  STUDY CHAIR

• Patrick O'Gara, MD

  Brigham and Women's Hospital

  STUDY CHAIR

• Annetine Gelijns, Ph.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Alan Moskowitz, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 26, 2017
• Results First Posted: June 26, 2017

Record last verified: 2017-04

Locations

US (19); CA (7); DK (1)