Moderate Mitral Regurgitation in CABG Patients
MoMIC
2 other identifiers
interventional
550
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedNovember 11, 2008
November 1, 2008
2.3 years
January 31, 2008
November 10, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death or rehospitalization for heart failure
5 yrs
Study Arms (2)
1
ACTIVE COMPARATORCABG Alone
2
ACTIVE COMPARATORCABG + Mitral repair
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 yrs.
- 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.
You may not qualify if:
- Patients with previous cardiac surgery.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby,
Aarhus, 8000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Per N Wierup, MD, PhD
Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 31, 2008
First Posted
February 13, 2008
Study Start
February 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2015
Last Updated
November 11, 2008
Record last verified: 2008-11