Randomised Ischaemic Mitral Evaluation (RIME) Trial

Imperial College London

Status and phase: Completed; Early Phase 1

Conditions: Coronary Artery Disease; Mitral Regurgitation

Treatments: Procedure: CABG; Procedure: CABG + Mitral valve annuloplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT00413998

2006HS020B

NIHR Portfolio ID 4129 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 73 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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73 participants in 2 patient groups

CABG + Mitral valve repair

Experimental group

Treatment:

Procedure: CABG + Mitral valve annuloplasty

CABG only

Active Comparator group

Treatment:

Procedure: CABG