Randomised Ischaemic Mitral Evaluation (RIME) Trial

Study Overview
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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.

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.

Official Title
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Randomized Evaluation of Mitral Annuloplasty During Coronary Artery Bypass Grafting for Moderate Functional Ischaemic Mitral Regurgitation.

Conditions
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Mitral Regurgitation, Coronary Artery Disease

Intervention / Treatment
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* Procedure: CABG + Mitral valve annuloplasty
* Procedure: CABG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing CABG. Patients with moderate functional ischaemic mitral regurgitation without leaflet prolapse. Exclusion Criteria: Patients with severe LV dysfunction (EF less than 30%). Patients with associated significant aortic valve disease. 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). Patients with NYHA class IV symptoms, unstable angina, acute pulmonary oedema or cardiogenic shock. Patients unsuitable for surgery e.g. patients with advanced malignancy, unable to give informed consent. Patients with structural abnormalities of the mitral valve e.g. papillary muscle rupture, chordal rupture, etc. Patients with associated conditions which would significantly increase the risk of surgery. Patients who have had previous cardiac surgery. Patients with a previous history of endocarditis
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CABG + Mitral valve repair<br> | Procedure: CABG + Mitral valve annuloplasty<br>* Patients will receive a mitral annuloplasty ring in addition to coronary artery bypass grafting.<br>|
| Active Comparator: CABG only<br> | Procedure: CABG<br>* Patients will undergo coronary artery bypass grafting alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular volumes |  | 1 year | 
| Mitral regurgitation grade |  | 1 year | 
| Neurohormonal levels |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional ischaemic mitral regurgitation