Surgical Treatment of Ischemic Mitral Regurgitation (TIME)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Meshalkin Research Institute of Pathology of Circulation
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01368575
First received: May 24, 2011
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Mitral Valve Insufficiency
Procedure: CABG
Procedure: 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
Procedure: CABG and MV replacement
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of IMR [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 420
Study Start Date: May 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: CABG combined with MV repair with remodeling annuloplasty rigid ring
Active Comparator: subgroup A1
only CABG
Procedure: CABG
CABG
Other Name: 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 Name: patients in subgroup B3 will be performed CABG and MV replacement with preservation of subvalvular apparatus

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368575

Contacts
Contact: Alexander Cherniavskiy, MD, Prof. +7 383 3322655 amchern@mail.ru
Contact: Vidadi Efendiev, MD +7 383 3322655 vidadiue@gmail.com

Locations
Russian Federation
State Research Institute of Circulation Patholody Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Alexander Cherniavskiy, MD, PhD    +73833322655    amchern@mail.ru   
Contact: Vidadi Efendiev, M.D    +73833322655    vidadiue@gmail.com   
Sub-Investigator: Vidadi Efendiev, MD.         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: Alexander Cherniavskiy, MD, PhD State Research Institute of Circulation Patholody Novosibirsk, 630055 Russian Federation
  More Information

No publications provided

Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01368575     History of Changes
Other Study ID Numbers: TIME-002
Study First Received: May 24, 2011
Last Updated: November 29, 2013
Health Authority: Russia: Ethics Committee

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Ischemic
Mitral
Valve
Insufficiency
SVR

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on October 30, 2014