Moderate Mitral Regurgitation in CABG Patients (MoMIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2008 by University of Aarhus
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00613548
First received: January 31, 2008
Last updated: November 10, 2008
Last verified: November 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Moderate Mitral Regurgitation in CABG Patients

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Death or rehospitalization for heart failure [ Time Frame: 5 yrs ] [ Designated as safety issue: Yes ]

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
Active Comparator: 1
CABG Alone
Procedure: CABG alone
CABG alone
Active Comparator: 2
CABG + Mitral repair
Procedure: CABG + Mitral repair
CABG + Mitral repair

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613548

Contacts
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

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

No publications provided

Responsible Party: Per Wierup MD, PhD, Assoc Prof, Dep of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Denmark
ClinicalTrials.gov Identifier: NCT00613548     History of Changes
Other Study ID Numbers: MoMIC, 20040224
Study First Received: January 31, 2008
Last Updated: November 10, 2008
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Moderate
Mitral
Regurgitation
CABG

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

ClinicalTrials.gov processed this record on July 31, 2014