Surgical Treatment of Ischemic Mitral Regurgitation (TIME)

September 21, 2015 updated by: Meshalkin Research Institute of Pathology of Circulation

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

420

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alexander Cherniavskiy, MD, Prof.
  • Phone Number: +7 383 3322655
  • Email: amchern@mail.ru

Study Contact Backup

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • Recruiting
        • State Research Institute of Circulation Patholody
        • Contact:
          • Alexander Cherniavskiy, MD, PhD
          • Phone Number: +73833322655
          • Email: amchern@mail.ru
        • Contact:
        • Sub-Investigator:
          • Vidadi Efendiev, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: subgroup B1
subgroup B1 will receive CABG combined with MV repair with annuloplasty rigid ring
Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring
CABG combined with MV repair with remodeling annuloplasty rigid ring
Other Names:
  • patients in subgroup B1 will receive CABG combined with MV repair with remodeling annuloplasty rigid ring
Active Comparator: subgroup B2
B2 - 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 and endoventricularplasty of subvalvular apparatus
CABG combined with MV repair with remodeling annuloplasty
Other Names:
  • CABG grafting combined with MV repair with remodeling annuloplasty and endoventricularplasty of subvalvular
Active Comparator: subgroup A2
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
Other Names:
  • patients in subgroup B1 will receive CABG combined with MV repair with remodeling annuloplasty rigid ring
Active Comparator: subgroup A1
only CABG
Procedure: CABG
CABG
Other Names:
  • will be performed only CABG (subgroup A1)
Active Comparator: subgroup B3
patients in subgroup B3 will be performed CABG and MV replacement with preservation of subvalvular apparatus
Procedure: CABG and MV replacement
coronary artery bypass grafting and mitral valve replacement
Other Names:
  • patients in subgroup B3 will be performed CABG and MV replacement with preservation of subvalvular apparatus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3,6,12,24,36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of IMR
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Investigators

  • Principal Investigator: Alexander Cherniavskiy, MD, PhD, State Research Institute of Circulation Patholody Novosibirsk, 630055 Russian Federation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

May 24, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (Estimate)

June 8, 2011

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIME-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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