Surgical Treatment of Ischemic Mitral Regurgitation (TIME)

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 4

Conditions: Mitral Valve Insufficiency

Treatments: Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus; Procedure: CABG; Procedure: CABG and MV replacement; Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01368575

TIME-002

Details and patient eligibility

About

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.

Enrollment: 420 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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420 participants in 5 patient groups

subgroup B1

Active Comparator group

Description:

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

Treatment:

Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring

Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring

subgroup B2

Active Comparator group

Description:

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

Treatment:

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

subgroup A2

Active Comparator group

Description:

CABG combined with MV repair with remodeling annuloplasty rigid ring

Treatment:

Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring

Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring

subgroup A1

Active Comparator group

Description:

only CABG

Treatment:

Procedure: CABG

subgroup B3

Active Comparator group

Description:

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

Treatment:

Procedure: CABG and MV replacement