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Moderate Mitral Regurgitation in CABG Patients (MoMIC)

Primary Purpose

Moderate Mitral Regurgitation

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CABG alone
CABG + Mitral repair
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Mitral Regurgitation focused on measuring Moderate, Mitral, Regurgitation, CABG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

CABG Alone

CABG + Mitral repair

Outcomes

Primary Outcome Measures

Death or rehospitalization for heart failure

Secondary Outcome Measures

Full Information

First Posted
January 31, 2008
Last Updated
November 10, 2008
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT00613548
Brief Title
Moderate Mitral Regurgitation in CABG Patients
Acronym
MoMIC
Official Title
Moderate Mitral Regurgitation in CABG Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Mitral Regurgitation
Keywords
Moderate, Mitral, Regurgitation, CABG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
CABG Alone
Arm Title
2
Arm Type
Active Comparator
Arm Description
CABG + Mitral repair
Intervention Type
Procedure
Intervention Name(s)
CABG alone
Intervention Description
CABG alone
Intervention Type
Procedure
Intervention Name(s)
CABG + Mitral repair
Intervention Description
CABG + Mitral repair
Primary Outcome Measure Information:
Title
Death or rehospitalization for heart failure
Time Frame
5 yrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Per N Wierup, MD, PhD
Phone
+45 89495566
Ext
5424
Email
pwi@sks.aaa.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Sten Lyager Nielsen, MD, DMSc
Phone
+45 89495566
Ext
5422
Email
lyager@ki.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per N Wierup, MD, PhD
Organizational Affiliation
Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby,
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Moderate Mitral Regurgitation in CABG Patients

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