Mitral Valve Repair Combined Coronary Artery Bypass Grafting(CABG) Verus CABG Alone on Functional Ischemic Mitral Regurgitation

Study Overview
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Brief Summary
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Coronary artery bypass grafting(CABG) is an effective procedure in treating severe coronary artery disease(CAD). Optimal surgical method for CAD patients with functional ischemic mitral regurgitation(FIMR) is still controversial. This study will evaluate the different effectiveness of CABG plus mitral valve annuloplasty versus CABG alone on patients with moderate FIMR.

Detailed Description
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CAD is a severe health problem worldwide. It is a result of plaque buildup, and eventually leads to the reduction of blood supply on myocardium. CABG is one of the procedure to improve symptoms caused by myocardial ischemia. And it is especially effective in treating severe coronary artery disease. FIMR is one of the most common complications of CAD. After acute myocardial infarction, FIMR will occur in 17%-55% patients, and 3%-19% of them will develop into moderate or severe MR eventually. FIMR is an important prognostic factor of CAD, the in-hospital mortality rate of patients with IMR is significantly higher in several studies. In patients with mild MR, CABG alone is enough to improve myocardial ischemia; however, in people with moderate mitral regurgitation, there is still a dispute on whether mitral valve annuloplasty is beneficial at the time of CABG. The purpose of this study is to determine the optimal surgical procedure of CAD patients combined moderate FIMR. This study will compare the effectiveness of different surgical procedure on people with moderate FIMR by enrolling people with enrolling people with CAD who require CABG procedure and have moderate mitral regurgitation. At baseline study, a questionnaire will be assigned to undergo either CABG surgery of CABG plus mitral calve annuloplasty. Blood, urine and tissue samples will be collected after the surgery. All participants will be followed up at month 1,3,6,12, participants will take part in a medication history review, a physical examination, a blood collection to evaluate the brain natriuretic peptide and an echocardiogram.

Official Title
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The Randomly Controlled Trial of Optimal Surgical Method for CAD Patients Combined Moderate Functional Ischemic Mitral Regurgitation

Conditions
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Coronary Artery Disease, Mitral Valve Insufficiency

Intervention / Treatment
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* Procedure: CABG
* Procedure: mitral valve annuloplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CAD that is amenable to CABG and a clinical indication for revascularization Moderate mitral regurgitation in the judgment of the clinical site echocardiographer, quantitative guidelines as proposed would be: jet area between 4 cmsq to 8 cmsq, jet area/left atrial area ratio between 20% to 39% Age ≥ 18 years Mitral valve annuloplasty is applicable Exclusion Criteria: Organic mitral insufficiency caused by rupture of papillary muscle, rheumatic fever, degeneration or infectious endocarditis Jet area of mitral valve cannot be evaluated by echocardiogram In combination of other procedures such as surgery on tricuspid valve, aortic valve, congenital heart diseases or diseases of the thoracic arteries Prior surgical or percutaneous mitral valve repair Contraindication to cardiopulmonary bypass (CPB) Clinical signs of cardiogenic shock at the time of randomization Treatment with medication prior to the surgery Severe, irreversible pulmonary hypertension in the judgment of the investigator 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CABG+mitral valve annuloplasty<br>Participants will undergo CABG and mitral valve annuloplasty. | Procedure: CABG<br>* CABG will be performed using standard surgical techniques. All procedures will be performed with cardiopulmonary bypass(CPB). Saphenous vein(SV)will be used as conduit but harvesting methods will not be prescribed, and 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, judging by the surgical investigator.<br>Procedure: mitral valve annuloplasty<br>* Surgical techniques for mitral valve annuloplasty 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.<br>|
| Active Comparator: CABG<br>Participants will undergo CABG only. | Procedure: CABG<br>* CABG will be performed using standard surgical techniques. All procedures will be performed with cardiopulmonary bypass(CPB). Saphenous vein(SV)will be used as conduit but harvesting methods will not be prescribed, and 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, judging by the surgical investigator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular End Systolic Volume Index (LVESVI) |  | Measured at month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative death |  | Measured during operation | 
| In-hospital death | death during the time of hospitalization | 1 year | 
| Short-term complications | Postoperative perivalvular leakage or heart failure | Measured within 1 week after operation | 
| Rehospitalization | Re-hospitalization caused by heart failure or aggravated mitral regurgitation | 1 year |