Surgical Treatment of Ischemic Mitral Regurgitation

Phase 4

• Conditions: Mitral Valve Insufficiency
• Interventions: Procedure: 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; Procedure: CABG; Procedure: CABG and MV replacement

• Registration Number: NCT01368575
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-24
• Study First Submitted QC: 2011-06-07
• Study First Posted: 2011-06-08
• Primary Completion: 2014-05
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 420

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
subgroup B2	CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus	B2 - CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus
subgroup A2	CABG combined with MV repair with remodeling annuloplasty rigid ring	CABG combined with MV repair with remodeling annuloplasty rigid ring
subgroup B1	CABG combined with MV repair with remodeling annuloplasty rigid ring	subgroup B1 will receive CABG combined with MV repair with annuloplasty rigid ring
subgroup A1	CABG	only CABG
subgroup B3	CABG and MV replacement	patients in subgroup B3 will be performed CABG and MV replacement with preservation of subvalvular apparatus

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Assessment of IMR	3 years

Trial Locations

Locations (1)

State Research Institute of Circulation Patholody; 🇷🇺 Novosibirsk, Russian Federation