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.

Meshalkin Research Institute of Pathology of Circulation1 site in 1 country420 target enrollmentMay 2011

ConditionsMitral Valve Insufficiency

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Mitral Valve Insufficiency
Sponsor: Meshalkin Research Institute of Pathology of Circulation
Enrollment: 420
Locations: 1
Primary Endpoint: 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.
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

November 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Time Frame: 3,6,12,24,36 months