Should we Repair Ischemic Mitral Regurgitation?

May 27, 2008 updated by: Medical University of Silesia
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Katowice, Poland, 40-635
        • Recruiting
        • 2nd Dept of Cardiac Surgery, Medical University of Silesia
        • Contact:
        • Principal Investigator:
          • Marek A Deja, MD PhD
        • Sub-Investigator:
          • Marcin Malinowski
        • Sub-Investigator:
          • Krzysztof S Golba, MD PhD
        • Sub-Investigator:
          • Jolanta Biernat, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Coronary Artery Bypass Grafting with no Mitral Valve intervention
Active Comparator: 2
Coronary Artery Bypass Grafting + Mitral Annuloplasty
Procedure: Mitral valve repair
mitral valve annuloplasty

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Collaborators

Ministry of Health, Poland

Investigators

  • Principal Investigator: Marek A Deja, MD PhD, Medical University of Silesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Registration Dates

First Submitted

March 2, 2007

First Submitted That Met QC Criteria

March 2, 2007

First Posted (Estimate)

March 6, 2007

Study Record Updates

Last Update Posted (Estimate)

May 30, 2008

Last Update Submitted That Met QC Criteria

May 27, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6/252/35/3747

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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