Randomised Ischaemic Mitral Evaluation (RIME) Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-08-31

Brief Summary

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The study is a randomised controlled trial comparing two treatment strategies for patients with moderate functional ischaemic mitral regurgitation undergoing coronary artery bypass grafting (CABG). Patients will be randomised to receive either CABG alone or CABG plus mitral annuloplasty. The objective of the study is to determine if mitral annuloplasty in addition to CABG improves outcome in patients with moderate functional ischaemic mitral regurgitation.

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Detailed Description

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70 patients with moderate functional ischaemic MR who are undergoing CABG will be recruited. Patients will be randomised to undergo either CABG alone or CABG combined with mitral annuloplasty. Patients will be investigated at baseline, 3 months and 1 year after surgery to determine functional capacity, quality of life, and cardiac function.

Conditions

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Mitral Regurgitation Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CABG + Mitral valve repair

Group Type EXPERIMENTAL

CABG + Mitral valve annuloplasty

Intervention Type PROCEDURE

Patients will receive a mitral annuloplasty ring in addition to coronary artery bypass grafting.

CABG only

Group Type ACTIVE_COMPARATOR

CABG

Intervention Type PROCEDURE

Patients will undergo coronary artery bypass grafting alone.

Interventions

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CABG + Mitral valve annuloplasty

Patients will receive a mitral annuloplasty ring in addition to coronary artery bypass grafting.

Intervention Type PROCEDURE

CABG

Patients will undergo coronary artery bypass grafting alone.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients undergoing CABG.
2. Patients with moderate functional ischaemic mitral regurgitation without leaflet prolapse.

Exclusion Criteria

1. Patients with severe LV dysfunction (EF less than 30%).
2. Patients with associated significant aortic valve disease.
3. Patients with significant co-morbidities: renal impairment (creatinine \> 160), liver impairment (INR \> 2.0, bilirubin \> 40), or underlying chronic obstructive lung disease (FEV1:FVC ratio \< 0.6).
4. Patients with NYHA class IV symptoms, unstable angina, acute pulmonary oedema or cardiogenic shock.
5. Patients unsuitable for surgery e.g. patients with advanced malignancy, unable to give informed consent.
6. Patients with structural abnormalities of the mitral valve e.g. papillary muscle rupture, chordal rupture, etc.
7. Patients with associated conditions which would significantly increase the risk of surgery.
8. Patients who have had previous cardiac surgery.
9. Patients with a previous history of endocarditis

Eligible Sex

ALL

Accepts Healthy Volunteers

No