Status:
COMPLETED
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
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
Conditions:
Mitral Valve Insufficiency
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT00806988
Start Date
December 1 2008
End Date
May 1 2015
Last Update
June 26 2017
Active Locations (27)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
Emory University
Atlanta, Georgia, United States, 30383
3
Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
4
University of Maryland
Baltimore, Maryland, United States, 21201