Should we Repair Ischemic Mitral Regurgitation?

This study is currently recruiting participants.

Verified by Medical University of Silesia, May 2008

Sponsors and Collaborators:	Medical University of Silesia Ministry of Health, Poland
Information provided by:	Medical University of Silesia
ClinicalTrials.gov Identifier:	NCT00443365

Purpose

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.

Condition	Intervention
Coronary Disease Mitral Valve Insufficiency	Procedure: Mitral valve repair

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Medical University of Silesia:

Estimated Enrollment:	100
Study Start Date:	March 2007

Arms	Assigned Interventions
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 mitral valve annuloplasty

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443365

Contacts

Contact: Marek A Deja, MD PhD

48-32-359-8542

mdeja@slam.katowice.pl

Locations

Poland
2nd Dept of Cardiac Surgery, Medical University of Silesia	Recruiting
Katowice, Poland, 40-635
Contact: Marek A Deja, MD PhD 48-32-252-6093 mdeja@slam.katowice.pl
Principal Investigator: Marek A Deja, MD PhD
Sub-Investigator: Marcin Malinowski
Sub-Investigator: Krzysztof S Golba, MD PhD
Sub-Investigator: Jolanta Biernat, MD

Sponsors and Collaborators

Medical University of Silesia

Ministry of Health, Poland

Investigators

Principal Investigator:

Marek A Deja, MD PhD

Medical University of Silesia

More Information

Study ID Numbers:	6/252/35/3747
Study First Received:	March 2, 2007
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00443365
Health Authority:	Poland: Bioethics Committee of Medical University of Silesia

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Arteriosclerosis
Ischemia
Coronary Artery Disease
Heart Valve Diseases
Mitral Valve Insufficiency

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009