Moderate Mitral RegurgitationMoMICNCT00613548
Moderate Mitral Regurgitation in CABG Patients
A study testing CABG alone and CABG + Mitral repair in people with Moderate Mitral Regurgitation, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate Mitral Regurgitation
- What is being tested?
- CABG alone and CABG + Mitral repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2008to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Significant mitral annular calcification.
- Type II MR (ruptured papillary muscle, or infracted elongated papillary muscle with prolapse)
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby,
Aarhus, 8000
About this study
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.
Read more
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
- Being tested
- CABG alone, CABG + Mitral repair
- Keywords
- Moderate, Mitral, Regurgitation, CABG
- Medical subject headings
- Lymphoma, Follicular, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABG aloneProcedure or surgery
CABG alone
CABG + Mitral repairProcedure or surgery
CABG + Mitral repair
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | CABG Alone Receives: Procedure: CABG alone |
| 2 | Active comparator | CABG + Mitral repair Receives: Procedure: CABG + Mitral repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or rehospitalization for heart failure
Measured: 5 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2010 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Per N Wierup, MD, PhD, Principal investigator, Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613548
- Sponsor's protocol ID
- MoMIC
- Other IDs
- 20040224
- Acronym
- MoMIC
- Status last verified
- Nov 2008
- First submitted
- 31 Jan 2008
- Last updated
- 11 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate Mitral Regurgitation in CABG Patients
- ClinicalTrials.gov ID
- NCT00613548
- Acronym / sponsor ID
- MoMIC / MoMIC
- Conditions
- Moderate Mitral Regurgitation
- Keywords
- Moderate, Mitral, Regurgitation, CABG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: CABG aloneCABG Alone |
| 2 | Active comparator | Procedure: CABG + Mitral repairCABG + Mitral repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CABG aloneCABG alone | Procedure or surgery | 1 |
| CABG + Mitral repairCABG + Mitral repair | Procedure or surgery | 2 |
Primary outcome
Death or rehospitalization for heart failure
Time frame: 5 yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per N Wierup, MD, PhD principal investigator
Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CABG alone and CABG + Mitral repair in people with Moderate Mitral Regurgitation, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Per N Wierup, MD, PhD (+45 89495566 ext. 5424, pwi@sks.aaa.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or rehospitalization for heart failure (time frame: 5 yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2008.