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Surgical Treatment of Ischemic Mitral Regurgitation (TIME)

Primary Purpose

Mitral Valve Insufficiency

Status
Unknown status
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
CABG
CABG combined with MV repair with remodeling annuloplasty rigid ring
CABG combined with MV repair with remodeling annuloplasty rigid ring
CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus
CABG and MV replacement
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Insufficiency focused on measuring Ischemic, Mitral, Valve, Insufficiency, SVR

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • State Research Institute of Circulation PatholodyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

subgroup B1

subgroup B2

subgroup A2

subgroup A1

subgroup B3

Arm Description

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

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

CABG combined with MV repair with remodeling annuloplasty rigid ring

only CABG

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

Outcomes

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.

Secondary Outcome Measures

Assessment of IMR

Full Information

First Posted
May 24, 2011
Last Updated
September 21, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT01368575
Brief Title
Surgical Treatment of Ischemic Mitral Regurgitation
Acronym
TIME
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Insufficiency
Keywords
Ischemic, Mitral, Valve, Insufficiency, SVR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
subgroup B1
Arm Type
Active Comparator
Arm Description
subgroup B1 will receive CABG combined with MV repair with annuloplasty rigid ring
Arm Title
subgroup B2
Arm Type
Active Comparator
Arm Description
B2 - CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus
Arm Title
subgroup A2
Arm Type
Active Comparator
Arm Description
CABG combined with MV repair with remodeling annuloplasty rigid ring
Arm Title
subgroup A1
Arm Type
Active Comparator
Arm Description
only CABG
Arm Title
subgroup B3
Arm Type
Active Comparator
Arm Description
patients in subgroup B3 will be performed CABG and MV replacement with preservation of subvalvular apparatus
Intervention Type
Procedure
Intervention Name(s)
CABG
Other Intervention Name(s)
will be performed only CABG (subgroup A1)
Intervention Description
CABG
Intervention Type
Procedure
Intervention Name(s)
CABG combined with MV repair with remodeling annuloplasty rigid ring
Intervention Description
CABG combined with MV repair with remodeling annuloplasty rigid ring
Intervention Type
Procedure
Intervention Name(s)
CABG combined with MV repair with remodeling annuloplasty rigid ring
Other Intervention Name(s)
patients in subgroup B1 will receive CABG combined with MV repair with remodeling annuloplasty rigid ring
Intervention Description
CABG combined with MV repair with remodeling annuloplasty rigid ring
Intervention Type
Procedure
Intervention Name(s)
CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus
Other Intervention Name(s)
CABG grafting combined with MV repair with remodeling annuloplasty and endoventricularplasty of subvalvular
Intervention Description
CABG combined with MV repair with remodeling annuloplasty
Intervention Type
Procedure
Intervention Name(s)
CABG and MV replacement
Other Intervention Name(s)
patients in subgroup B3 will be performed CABG and MV replacement with preservation of subvalvular apparatus
Intervention Description
coronary artery bypass grafting and mitral valve replacement
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Assessment of IMR
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Cherniavskiy, MD, Prof.
Phone
+7 383 3322655
Email
amchern@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Vidadi Efendiev, MD
Phone
+7 383 3322655
Email
vidadiue@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Cherniavskiy, MD, PhD
Organizational Affiliation
State Research Institute of Circulation Patholody Novosibirsk, 630055 Russian Federation
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Research Institute of Circulation Patholody
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Cherniavskiy, MD, PhD
Phone
+73833322655
Email
amchern@mail.ru
First Name & Middle Initial & Last Name & Degree
Vidadi Efendiev, M.D
Phone
+73833322655
Email
vidadiue@gmail.com
First Name & Middle Initial & Last Name & Degree
Vidadi Efendiev, MD.

12. IPD Sharing Statement

Learn more about this trial

Surgical Treatment of Ischemic Mitral Regurgitation

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