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Sponsored by: |
University of Aarhus |
Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00613548 |
Background:
The presence of a mild to moderate ischemic mitral regurgitation (IMR) results in a significantly reduced long-term survival and increased hospitalizations for heart-failure. The benefit of adding mitral valve surgery to coronary artery by-pass surgery (CABG) is well documented in the combination of coronary artery disease and severe MR. On the other hand, it is clinical practice to refrain from repairing the mitral valve in those CABG cases where the IMR is mild to moderate. However, there are no conclusive data available to support this principle. The existing studies are small, retrospective, and the results contradictive. The need for a prospective randomized trial has frequently been proposed and discussed, however, to the best of our knowledge, such a study has not yet commenced.
Study design:
The Moderate Mitral Regurgitation In Patients Undergoing CABG (MoMIC) Trial is the first international multi-center, large-scale study to clarify whether moderate IMR in CABG patients should be corrected. A total of 550 CABG patients with moderate IMR are to be randomized to either CABG alone or CABG plus mitral valve correction.
Implication:
If correction of moderate MR in CABG patients is the superior strategy, this should be offered to all patients in this entity.
Condition | Intervention |
Moderate Mitral Regurgitation |
Procedure: CABG alone Procedure: CABG + Mitral repair |
MedlinePlus related topics: | Heart Failure |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment |
Official Title: | Moderate Mitral Regurgitation in CABG Patients |
Estimated Enrollment: | 550 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | June 2015 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
CABG Alone
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Procedure: CABG alone
CABG alone
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2: Active Comparator
CABG + Mitral repair
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Procedure: CABG + Mitral repair
CABG + Mitral repair
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Per N Wierup, MD, PhD | +45 89495566 ext 5424 | pwi@sks.aaa.dk |
Contact: Sten Lyager Nielsen, MD, DMSc | +45 89495566 ext 5422 | lyager@ki.au.dk |
Denmark | |||||
Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, | |||||
Aarhus, Denmark, 8000 |
University of Aarhus |
Principal Investigator: | Per N Wierup, MD, PhD | Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Denmark |
Responsible Party: | Dep of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Denmark ( Per Wierup MD, PhD, Assoc Prof ) |
Study ID Numbers: | MoMIC, 20040224 |
First Received: | January 31, 2008 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00613548 |
Health Authority: | Denmark: Ethics Committee |
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