Surgical Treatment of Ischemic Mitral Regurgitation (TIME)
This study is currently recruiting participants.
Verified June 2011 by Meshalkin Research Institute of Pathology of Circulation
Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Information provided by:
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01368575
First received: May 24, 2011
Last updated: June 7, 2011
Last verified: June 2011
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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 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
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: | Alexander Cherniavskiy, State Research Institute of Circulation Pathology |
| ClinicalTrials.gov Identifier: | NCT01368575 History of Changes |
| Other Study ID Numbers: | TIME-002 |
| Study First Received: | May 24, 2011 |
| Last Updated: | June 7, 2011 |
| 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 Heart Valve Diseases Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013