NCT00394797

Brief Summary

The purpose of this study is to try and determine whether repair of moderate ischemic mitral regurgitation at the time of coronary bypass graft surgery (CABG) has an impact on survival.We will compare patients undergoing CABG + mitral repair or CABG only groups. Primary endpoints include late survival. Secondary endpoints include event free survival, symptoms, and echocardiographic outcomes.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2006

Completed
Last Updated

June 1, 2011

Status Verified

May 1, 2011

First QC Date

October 31, 2006

Last Update Submit

May 31, 2011

Conditions

Moderate Ischemic Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

  • survival at 1,5 and 10 years

Secondary Outcomes (3)

  • event free survival

  • symptoms

  • echocardiographic parameters

Interventions

mitral valve annuloplastyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing coronary bypass surgery who have moderate degree of ischemic MR

You may qualify if:

  • patients undergoing coronary bypass surgery who have moderate degree of ischemic MR

You may not qualify if:

  • etiology of mitral regurgitation other than ischemic, degree of regurgitation other than moderate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

MeSH Terms

Interventions

Mitral Valve Annuloplasty

Intervention Hierarchy (Ancestors)

Cardiac Valve AnnuloplastyCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Shuli Silberman, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2006

First Posted

November 1, 2006

Last Updated

June 1, 2011

Record last verified: 2011-05

Locations

IL(1)