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Should we Repair Ischemic Mitral Regurgitation?

Primary Purpose

Coronary Disease, Mitral Valve Insufficiency

Status

Unknown status

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Mitral valve repair

Sponsored by

Medical University of Silesia

About this trial

This is an interventional treatment trial for Coronary Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

2nd Dept of Cardiac Surgery, Medical University of SilesiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

1

2

Arm Description

Coronary Artery Bypass Grafting with no Mitral Valve intervention

Coronary Artery Bypass Grafting + Mitral Annuloplasty

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

First Posted

March 2, 2007

Last Updated

May 27, 2008

Sponsor

Medical University of Silesia

Collaborators

Ministry of Health, Poland

1. Study Identification

Unique Protocol Identification Number

NCT00443365

Brief Title

Should we Repair Ischemic Mitral Regurgitation?

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Unknown status

Study Start Date

March 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Silesia

Collaborators

Ministry of Health, Poland

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Disease, Mitral Valve Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

No Intervention

Arm Description

Coronary Artery Bypass Grafting with no Mitral Valve intervention

Arm Title

2

Arm Type

Active Comparator

Arm Description

Coronary Artery Bypass Grafting + Mitral Annuloplasty

Intervention Type

Procedure

Intervention Name(s)

Mitral valve repair

Intervention Description

mitral valve annuloplasty

10. Eligibility

Sex

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Stable coronary artery disease Patient accepted for coronary artery bypass surgery Ischemic mitral regurgitation Exclusion Criteria: Acute coronary syndrome within 30 days Organic valvular heart disease Need for other than CABG and mitral valve repair cardiac surgical procedure

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marek A Deja, MD PhD

Phone

48-32-359-8542

Email

mdeja@slam.katowice.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marek A Deja, MD PhD

Organizational Affiliation

Medical University of Silesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

2nd Dept of Cardiac Surgery, Medical University of Silesia

City

Katowice

ZIP/Postal Code

40-635

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marek A Deja, MD PhD

Phone

48-32-252-6093

Email

mdeja@slam.katowice.pl

First Name & Middle Initial & Last Name & Degree

Marek A Deja, MD PhD

First Name & Middle Initial & Last Name & Degree

Marcin Malinowski

First Name & Middle Initial & Last Name & Degree

Krzysztof S Golba, MD PhD

First Name & Middle Initial & Last Name & Degree

Jolanta Biernat, MD

12. IPD Sharing Statement

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Should we Repair Ischemic Mitral Regurgitation?

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