Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
550 participants
INTERVENTIONAL
2008-02-29
2015-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
CABG Alone
CABG alone
CABG alone
2
CABG + Mitral repair
CABG + Mitral repair
CABG + Mitral repair
Interventions
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CABG alone
CABG alone
CABG + Mitral repair
CABG + Mitral repair
Eligibility Criteria
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Inclusion Criteria
* The inclusion is independent of the left ventricular function.
* The inclusion is independent of the left atrial size.
* It is mandatory that the patient is able to fully understand the written information, the purpose of the study, and able to give an informed consent.
Exclusion Criteria
* Emergency surgery.
* Malignant disease with an expected survival of less than 5 years.
* ST-elevation myocardial infarction within 16 days.
* Significant aortic valve disease necessitating aortic valve replacement
* Calcification of the ascending aorta.
* Significant mitral annular calcification.
* Type II MR (ruptured papillary muscle, or infracted elongated papillary muscle with prolapse)
* Refusal to participate in the study.
18 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Dep of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Denmark
Principal Investigators
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Per N Wierup, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Denmark
Locations
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Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby,
Aarhus, , Denmark
Countries
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Central Contacts
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Other Identifiers
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20040224
Identifier Type: -
Identifier Source: secondary_id
MoMIC
Identifier Type: -
Identifier Source: org_study_id