- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00613548
Moderate Mitral Regurgitation in CABG Patients (MoMIC)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Recruiting
- Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby,
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
CABG Alone
|
CABG alone
|
Active Comparator: 2
CABG + Mitral repair
|
CABG + Mitral repair
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Death or rehospitalization for heart failure
Time Frame: 5 yrs
|
5 yrs
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Per N Wierup, MD, PhD, Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Denmark
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MoMIC
- 20040224
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Moderate Mitral Regurgitation
-
Shaare Zedek Medical CenterCompletedModerate Ischemic Mitral RegurgitationIsrael
-
Assiut UniversityNot yet recruitingModerate Ischemic Mitral RegurgitationEgypt
-
Abbott Medical DevicesCompletedFunctional Mitral Regurgitation | Degenerrative Mitral RegurgitationRussian Federation
-
Ancora Heart, Inc.CompletedMitral Regurgitation | Mitral Valve Regurgitation | Functional Mitral RegurgitationAustria, Lithuania, Germany
-
Heinrich-Heine University, DuesseldorfCompletedMitral Regurgitation | Functional Mitral Regurgitation | Degenerative Mitral Valve RegurgitationGermany
-
Mitre Medical Corp.BSWRI Cardiac Imaging Core Lab (CICL)Not yet recruitingIschemic Mitral Regurgitation | Functional Mitral RegurgitationUnited States
-
Abbott Medical DevicesCompletedMitral Valve Regurgitation | Mitral Valve Incompetence | Mitral Insufficiency | Functional Mitral Regurgitation | Mitral Stenosis With InsufficiencyJapan
-
Hospital Clinic of BarcelonaAbbottUnknownMITRAL REGURGITATIONSpain
-
Edwards LifesciencesRecruitingMitral Regurgitation | Mitral Insufficiency | Functional Mitral Regurgitation | Degenerative Mitral Valve DiseaseUnited States, Canada, Switzerland, Germany
-
Boston Scientific CorporationActive, not recruitingCardiovascular Diseases | Mitral Regurgitation Functional | Mitral Valve DiseaseUnited States, Australia
Clinical Trials on CABG alone
-
China National Center for Cardiovascular DiseasesUnknownCoronary Artery Disease | Congestive Heart Failure | Ischemic CardiomyopathyChina
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases | Coronary Disease | Heart Failure, CongestiveUnited States
-
Assiut UniversityRecruitingCAD - Coronary Artery DiseaseEgypt
-
Kuopio University HospitalTerminatedCoronary Artery Disease | Paroxysmal Atrial FibrillationFinland
-
St. Petersburg State Pavlov Medical UniversityRecruitingIschemic Heart Disease | Valve Heart Disease | Cardiac Procedure Complication | Defect SeptalRussian Federation
-
St. Petersburg State Pavlov Medical UniversityCompletedCoronary Artery Disease | CABG | Ischemic Heart Disease | Ischemic Reperfusion InjuryRussian Federation
-
Peking University Third HospitalNot yet recruitingMinimally Invasive Cardiac Surgery
-
Chinese Academy of SciencesThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical...CompletedChronic Ischemic CardiomyopathyChina
-
St. Petersburg State Pavlov Medical UniversityRecruitingIschemic Heart Disease | Coronary Artery Bypass GraftingRussian Federation
-
Imperial College LondonUniversity Hospitals, Leicester; Medical University of Silesia; Royal Brompton... and other collaboratorsCompletedCoronary Artery Disease | Mitral RegurgitationUnited Kingdom, Poland