Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
420 participants
INTERVENTIONAL
2011-05-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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subgroup B1
subgroup B1 will receive CABG combined with MV repair with annuloplasty rigid ring
CABG combined with MV repair with remodeling annuloplasty rigid ring
CABG combined with MV repair with remodeling annuloplasty rigid ring
subgroup B2
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 and endoventricularplasty of subvalvular apparatus
CABG combined with MV repair with remodeling annuloplasty
subgroup A2
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
subgroup A1
only CABG
CABG
CABG
subgroup B3
patients in subgroup B3 will be performed CABG and MV replacement with preservation of subvalvular apparatus
CABG and MV replacement
coronary artery bypass grafting and mitral valve replacement
Interventions
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CABG
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
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 combined with MV repair with remodeling annuloplasty
CABG and MV replacement
coronary artery bypass grafting and mitral valve replacement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
75 Years
ALL
No
Sponsors
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Meshalkin Research Institute of Pathology of Circulation
NETWORK
Responsible Party
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Principal Investigators
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Alexander Cherniavskiy, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
State Research Institute of Circulation Patholody Novosibirsk, 630055 Russian Federation
Locations
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State Research Institute of Circulation Patholody
Novosibirsk, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TIME-002
Identifier Type: -
Identifier Source: org_study_id
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