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

Coronary Artery Disease Clinical Trial

Official title:

Surgical Interventions for Moderate Ischemic Mitral Regurgitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806988
• Other study ID #: GCO 08-1078-00003
• Secondary ID: U01HL088942594
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2008
• Last updated: October 2, 2015
• Start date: December 2008
• Est. completion date: May 2015

Study information

• Verified date: October 2015
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentCanada: Canadian Institutes of Health ResearchCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00838786

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Mitral Valve Insufficiency
• Myocardial Ischemia

Intervention

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: 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. The heart will be arrested with cardioplegia. 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.
• 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.

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hôpital du Sacré-Coeur de Montréal	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Quebec Heart Institute/Laval Hopital	Quebec
Canada	Saint Michael's Hospital	Toronto	Ontario
Canada	University of Toronto Sunnybrook Health Science Centre	Toronto	Ontario
Canada	University of Toronto, Toronto General Hospital	Toronto	Ontario
Denmark	Aarhus University Hospital	Aarhus N
United States	Mission Hospital	Asheville	North Carolina
United States	Emory University	Atlanta	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	Montefiore Einstein Heart Center	Bronx	New York
United States	University of Virginia	Charlottesville	Virginia
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Duke University	Durham	North Carolina
United States	Inova Heart and Vascular Institute	Falls Church	Virginia
United States	East Carolina Heart Institute	Greenville	North Carolina
United States	University of Southern California	Los Angeles	California
United States	Wellstar Kennestone Hospital	Marietta	Georgia
United States	Columbia University Medical Center	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Baylor Research Institute	Plano	Texas
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Washington University	St Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Canadian Institutes of Health Research (CIHR), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS)

Countries where clinical trial is conducted

United States,  Canada,  Denmark, 

References & Publications (1)

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, Pagé P, Overbey JR, Bagiella E, Dagenais F, Blackstone EH, Kron IL, Goldstein DJ, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of left ventricular remodeling, as assessed by left ventricular end systolic volume index (LVESVI)		Measured at Month 12	No
Secondary	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	No

External Links

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