NCT00443365

Brief Summary

The purpose of this study is to assess whether adding mitral valve repair to coronary artery bypass grafting improves outcome in patients with ischemic mitral regurgitation.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

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

March 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2007

Completed
Last Updated

May 30, 2008

Status Verified

May 1, 2008

First QC Date

March 2, 2007

Last Update Submit

May 27, 2008

Conditions

Coronary DiseaseMitral Valve Insufficiency

Study Arms (2)

1

NO INTERVENTION

Coronary Artery Bypass Grafting with no Mitral Valve intervention

2

ACTIVE COMPARATOR

Coronary Artery Bypass Grafting + Mitral Annuloplasty

Procedure: Mitral valve repair

Interventions

Mitral valve repairPROCEDURE

mitral valve annuloplasty

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Stable coronary artery disease
  • Patient accepted for coronary artery bypass surgery
  • Ischemic mitral regurgitation

You may not qualify if:

  • Acute coronary syndrome within 30 days
  • Organic valvular heart disease
  • Need for other than CABG and mitral valve repair cardiac surgical procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Dept of Cardiac Surgery, Medical University of Silesia

Katowice, 40-635, Poland

RECRUITING

MeSH Terms

Conditions

Coronary DiseaseMitral Valve Insufficiency

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesHeart Valve Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Marek A Deja, MD PhD

    Medical University of Silesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marek A Deja, MD PhD

CONTACT

48-32-359-8542mdeja@slam.katowice.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2007

First Posted

March 6, 2007

Study Start

March 1, 2007

Last Updated

May 30, 2008

Record last verified: 2008-05

Locations

PL(1)