Surgical Treatment of Ischemic Mitral Regurgitation

Study Overview
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Brief Summary
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The primary objective is to estimate surgical treatment (prosthesis or plastic) of moderate and severe ischemic mitral regurgitation combined with CABG in patients with CAD and impact on heart failure and progress of mitral regurgitation.

Official Title
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The Effect of Different Surgical Methods in the Treatment of Patients With Ischemic Mitral Regurgitation and Assess the Dynamics of Heart Failure and the Effectiveness of Surgical Treatment of Mitral Valve.

Conditions
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Mitral Valve Insufficiency

Intervention / Treatment
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* Procedure: CABG
* Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring
* Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring
* Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus
* Procedure: CABG and MV replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is a male or female between 30 to 75 years of age (inclusive) on the day of signing the informed consent. Patients with a verified diagnosis of CAD, including post myocardial infarction scar. Coronary artery pathology to be coronary artery bypasses grafting. The presence of moderate or severe ischemic mitral regurgitation. Exclusion Criteria: The patient did not sign the informed consent. Aortic valve disease requiring prosthetic or aortic valve repair. Organic lesion of valve and subvalvular structures (endocarditis and degenerative processes of the mitral valve). а) separation of the mitral valve chords; б) rupture and perforation of the mitral valve; в) myxomatous degeneration and calcification of the mitral valve Patients with acute coronary syndrome. The presence of the indications for angioplasty of the coronary arteries. Coronary artery bypasses grafting in history. Parallel patient participation in other studies. The organs diseases, which can be reason to death after surgery during the first 3 years.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 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: subgroup B1<br>subgroup B1 will receive CABG combined with MV repair with annuloplasty rigid ring | Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring<br>* CABG combined with MV repair with remodeling annuloplasty rigid ring<br>* Other names: patients in subgroup B1 will receive CABG combined with MV repair with remodeling annuloplasty rigid ring;|
| Active Comparator: subgroup B2<br>B2 - CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus | Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus<br>* CABG combined with MV repair with remodeling annuloplasty<br>* Other names: CABG grafting combined with MV repair with remodeling annuloplasty and endoventricularplasty of subvalvular;|
| Active Comparator: subgroup A2<br>CABG combined with MV repair with remodeling annuloplasty rigid ring | Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring<br>* CABG combined with MV repair with remodeling annuloplasty rigid ring<br>|
| Active Comparator: subgroup A1<br>only CABG | Procedure: CABG<br>* CABG<br>* Other names: will be performed only CABG (subgroup A1);|
| Active Comparator: subgroup B3<br>patients in subgroup B3 will be performed CABG and MV replacement with preservation of subvalvular apparatus | Procedure: CABG and MV replacement<br>* coronary artery bypass grafting and mitral valve replacement<br>* Other names: patients in subgroup B3 will be performed CABG and MV replacement with preservation of subvalvular apparatus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the degree of mitral regurgitation in the early and late term of the study. Identify the cause of the return of IMR. Determine the dynamics of heart failure in patients with IMR. |  | 3,6,12,24,36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of IMR |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic, Mitral, Valve, Insufficiency, SVR