Surgical Treatment of Ischemic Mitral Regurgitation

NCT ID: NCT01368575

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-11-30

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.

Detailed Description

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Conditions

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Mitral Valve Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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subgroup B1

subgroup B1 will receive CABG combined with MV repair with annuloplasty rigid ring

Group Type ACTIVE_COMPARATOR

CABG combined with MV repair with remodeling annuloplasty rigid ring

Intervention Type PROCEDURE

CABG combined with MV repair with remodeling annuloplasty rigid ring

subgroup B2

B2 - CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus

Group Type ACTIVE_COMPARATOR

CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus

Intervention Type PROCEDURE

CABG combined with MV repair with remodeling annuloplasty

subgroup A2

CABG combined with MV repair with remodeling annuloplasty rigid ring

Group Type ACTIVE_COMPARATOR

CABG combined with MV repair with remodeling annuloplasty rigid ring

Intervention Type PROCEDURE

CABG combined with MV repair with remodeling annuloplasty rigid ring

subgroup A1

only CABG

Group Type ACTIVE_COMPARATOR

CABG

Intervention Type PROCEDURE

CABG

subgroup B3

patients in subgroup B3 will be performed CABG and MV replacement with preservation of subvalvular apparatus

Group Type ACTIVE_COMPARATOR

CABG and MV replacement

Intervention Type PROCEDURE

coronary artery bypass grafting and mitral valve replacement

Interventions

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CABG

CABG

Intervention Type PROCEDURE

CABG combined with MV repair with remodeling annuloplasty rigid ring

CABG combined with MV repair with remodeling annuloplasty rigid ring

Intervention Type PROCEDURE

CABG combined with MV repair with remodeling annuloplasty rigid ring

CABG combined with MV repair with remodeling annuloplasty rigid ring

Intervention Type PROCEDURE

CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus

CABG combined with MV repair with remodeling annuloplasty

Intervention Type PROCEDURE

CABG and MV replacement

coronary artery bypass grafting and mitral valve replacement

Intervention Type PROCEDURE

Other Intervention Names

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will be performed only CABG (subgroup A1) patients in subgroup B1 will receive CABG combined with MV repair with remodeling annuloplasty rigid ring CABG grafting combined with MV repair with remodeling annuloplasty and endoventricularplasty of subvalvular patients in subgroup B3 will be performed CABG and MV replacement with preservation of subvalvular apparatus

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Cherniavskiy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

State Research Institute of Circulation Patholody Novosibirsk, 630055 Russian Federation

Locations

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State Research Institute of Circulation Patholody

Novosibirsk, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Alexander Cherniavskiy, MD, Prof.

Role: CONTACT

+7 383 3322655

Vidadi Efendiev, MD

Role: CONTACT

+7 383 3322655

Facility Contacts

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Alexander Cherniavskiy, MD, PhD

Role: primary

+73833322655

Vidadi Efendiev, M.D

Role: backup

+73833322655

Other Identifiers

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TIME-002

Identifier Type: -

Identifier Source: org_study_id

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