Surgical Treatment of Ischemic Mitral Regurgitation

Mitral Valve Insufficiency Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01368575
• Other study ID #: TIME-002
• Status: Recruiting
• Phase: Phase 4
• First received: May 24, 2011
• Last updated: September 21, 2015
• Start date: May 2011
• Est. completion date: November 2015

Study information

• Verified date: September 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Alexander Cherniavskiy, MD, Prof.
• Phone: +7 383 3322655
• Email: amchern[@]mail.ru
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: November 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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).

?) separation of the mitral valve chords; ?) rupture and perforation of the mitral valve; ?) 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mitral Valve Insufficiency

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Russian Federation	State Research Institute of Circulation Patholody	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Assessment of IMR		3 years	Yes