Moderate Mitral Regurgitation in CABG Patients (MoMIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
University of Aarhus

Brief Summary:


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.


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Active Comparator: 1
CABG Alone
Procedure: CABG alone
CABG alone
Active Comparator: 2
CABG + Mitral repair
Procedure: CABG + Mitral repair
CABG + Mitral repair

Primary Outcome Measures :
  1. Death or rehospitalization for heart failure [ Time Frame: 5 yrs ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with ischemic heart disease, who fulfil the indications for CABG, and who also have a moderate ischemic MR. Ischemic MR is defined as mitral regurgitation due to coronary artery disease and not fortuitously associated with it. It is caused either by a mitral annular dilatation (Carpentier type I), or a restrictive motion of the posterior mitral leaflet (Carpentier type IIIb), or a combination of these. The mitral leaflets should be slender and without signs of intrinsic organic disease. The mitral annulus should be with no significant calcification that can be held responsible for valve insufficiency. The severity of mitral regurgitation is quantified by means of echoardiography using the Proximal Isovelocity Surface Area (PISA)-method. Moderate MR is defined as a calculated ERO of 15-30 mm2 at rest . Hence, patients referred for CABG and showing signs of mitral regurgitation on auscultation, by echocardiography, or by ventriculography will further be evaluated by a thorough echocardiography (Transthoracic (TTE) in ambiguous cases supplemented by transesophageal echocardiography (TEE) before surgery, in order to determine whether the patient fulfil the inclusion criteria. In addition, ejection fraction (visually estimated), left atrial dimension, mitral annular and tricuspid annular size, as well as estimates of pulmonary hypertension will be recorded.
  • Age ≥ 18 yrs.
  • 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:

  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00613548

Contact: Per N Wierup, MD, PhD +45 89495566 ext 5424
Contact: Sten Lyager Nielsen, MD, DMSc +45 89495566 ext 5422

Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Recruiting
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Principal Investigator: Per N Wierup, MD, PhD Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Denmark

Responsible Party: Per Wierup MD, PhD, Assoc Prof, Dep of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Denmark Identifier: NCT00613548     History of Changes
Other Study ID Numbers: MoMIC
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: November 11, 2008
Last Verified: November 2008

Keywords provided by University of Aarhus:

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases