NCT01368575

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
420

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 8, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

3 years

First QC Date

May 24, 2011

Last Update Submit

September 21, 2015

Conditions

Mitral Valve Insufficiency

Keywords

IschemicMitralValveInsufficiencySVR

Outcome Measures

Primary Outcomes (1)

  • 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.

    3,6,12,24,36 months

Secondary Outcomes (1)

  • Assessment of IMR

    3 years

Study Arms (5)

subgroup B1

ACTIVE COMPARATOR

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

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

subgroup B2

ACTIVE COMPARATOR

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

subgroup A2

ACTIVE COMPARATOR

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

only CABG

Procedure: CABG

subgroup B3

ACTIVE COMPARATOR

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

Procedure: CABG and MV replacement

Interventions

CABGPROCEDURE

CABG

Also known as: will be performed only CABG (subgroup A1)
subgroup A1
CABG combined with MV repair with remodeling annuloplasty rigid ringPROCEDURE

CABG combined with MV repair with remodeling annuloplasty rigid ring

subgroup A2
CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatusPROCEDURE

CABG combined with MV repair with remodeling annuloplasty

Also known as: CABG grafting combined with MV repair with remodeling annuloplasty and endoventricularplasty of subvalvular
subgroup B2
CABG and MV replacementPROCEDURE

coronary artery bypass grafting and mitral valve replacement

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

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Research Institute of Circulation Patholody

Novosibirsk, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Mitral Valve InsufficiencyIschemia

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander Cherniavskiy, MD, PhD

    State Research Institute of Circulation Patholody Novosibirsk, 630055 Russian Federation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Cherniavskiy, MD, Prof.

CONTACT

+7 383 3322655amchern@mail.ru

Vidadi Efendiev, MD

CONTACT

+7 383 3322655vidadiue@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2011

First Posted

June 8, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2014

Study Completion

November 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

RU(1)