Surgical Treatment of Ischemic Mitral Regurgitation

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: May 2014

Interventions

  • Procedure: CABG
    • CABG
  • Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring
    • CABG combined with MV repair with remodeling annuloplasty rigid ring
  • Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring
    • 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
    • CABG combined with MV repair with remodeling annuloplasty
  • Procedure: CABG and MV replacement
    • coronary artery bypass grafting and mitral valve replacement

Arms, Groups and Cohorts

  • Active Comparator: subgroup B1
    • subgroup B1 will receive CABG combined with MV repair with annuloplasty rigid ring
  • Active Comparator: subgroup B2
    • B2 – CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus
  • Active Comparator: subgroup A2
    • CABG combined with MV repair with remodeling annuloplasty rigid ring
  • Active Comparator: subgroup A1
    • only CABG
  • Active Comparator: subgroup B3
    • patients in subgroup B3 will be performed CABG and MV replacement with preservation of subvalvular apparatus

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Assessment of IMR
    • Time Frame: 3 years

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Meshalkin Research Institute of Pathology of Circulation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alexander Cherniavskiy, MD, PhD, Principal Investigator, State Research Institute of Circulation Patholody Novosibirsk, 630055 Russian Federation
  • Overall Contact(s)
    • Alexander Cherniavskiy, MD, Prof., +7 383 3322655, amchern@mail.ru

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