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NCT00443365 Clinical Trial

Should we Repair Ischemic Mitral Regurgitation?

Coronary Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00443365
Other study ID # 6/252/35/3747
Secondary ID
Status Recruiting
Phase N/A
First received March 2, 2007
Last updated May 27, 2008
Start date March 2007

Study information
Verified date May 2008
Source Medical University of Silesia
Contact Marek A Deja, MD PhD
Phone 48-32-359-8542
Email mdeja@slam.katowice.pl
Is FDA regulated No
Health authority Poland: Bioethics Committee of Medical University of Silesia
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Mitral valve repair
mitral valve annuloplasty

Locations
Country Name City State
Poland 2nd Dept of Cardiac Surgery, Medical University of Silesia Katowice

Sponsors (2)
Lead Sponsor Collaborator
Medical University of Silesia Ministry of Health, Poland

Country where clinical trial is conducted

Poland, 

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