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Moderate Mitral Regurgitation in CABG Patients

NCT00613548 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2008-11-11

No results posted yet for this study

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.

Conditions

  • Moderate Mitral Regurgitation

Interventions

PROCEDURE

CABG alone

CABG alone

PROCEDURE

CABG + Mitral repair

CABG + Mitral repair

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Per N Wierup, MD, PhD · Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-06-30
Completion
2015-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00613548 on ClinicalTrials.gov