Moderate Mitral Regurgitation in CABG Patients (MoMIC)
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|ClinicalTrials.gov Identifier: NCT00613548|
Recruitment Status : Unknown
Verified November 2008 by University of Aarhus.
Recruitment status was: Recruiting
First Posted : February 13, 2008
Last Update Posted : November 11, 2008
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.
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.
If correction of moderate MR in CABG patients is the superior strategy, this should be offered to all patients in this entity.
|Condition or disease||Intervention/treatment|
|Moderate Mitral Regurgitation||Procedure: CABG alone Procedure: CABG + Mitral repair|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||550 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Moderate Mitral Regurgitation in CABG Patients|
|Study Start Date :||February 2008|
|Estimated Primary Completion Date :||June 2010|
|Estimated Study Completion Date :||June 2015|
Active Comparator: 1
Procedure: CABG alone
Active Comparator: 2
CABG + Mitral repair
Procedure: CABG + Mitral repair
CABG + Mitral repair
- Death or rehospitalization for heart failure [ Time Frame: 5 yrs ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613548
|Contact: Per N Wierup, MD, PhD||+45 89495566 ext firstname.lastname@example.org|
|Contact: Sten Lyager Nielsen, MD, DMSc||+45 89495566 ext email@example.com|
|Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby,||Recruiting|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Per N Wierup, MD, PhD||Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Denmark|