Randomised Ischaemic Mitral Evaluation (RIME) Trial

Early Phase 1

Completed

• Conditions: Mitral Regurgitation; Coronary Artery Disease
• Interventions: Procedure: CABG + Mitral valve annuloplasty; Procedure: CABG

• Registration Number: NCT00413998
• Lead Sponsor: Imperial College London

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2006-12-19
• Study First Submitted QC: 2006-12-19
• Study First Posted: 2006-12-20
• Study Start: 2007-01
• Primary Completion: 2012-04
• Study Completion: 2012-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CABG + Mitral valve repair	CABG + Mitral valve annuloplasty	-
CABG only	CABG	-

Primary Outcome Measures

Name	Time	Method
Functional capacity	1 year

Secondary Outcome Measures

Name	Time	Method
Left ventricular volumes	1 year
Mitral regurgitation grade	1 year
Neurohormonal levels	1 year

Trial Locations

Locations (9)

Glenfield Hospital, Leicester; 🇬🇧 Leicester, United Kingdom

Heart Hospital, University College Hospital; 🇬🇧 London, United Kingdom

St. Mary's Hospital; 🇬🇧 London, United Kingdom

Blackpool Victoria Hospital; 🇬🇧 Blackpool, Lancashire, United Kingdom

Hammersmith Hospital; 🇬🇧 London, United Kingdom

Harefield Hospital; 🇬🇧 Harefield, United Kingdom

1st Dept of Cardiothoracic Surgery, Medical University of Silesia; 🇵🇱 Katowice, Poland

Bristol Heart Institute; 🇬🇧 Bristol, United Kingdom

Royal Brompton Hospital; 🇬🇧 London, United Kingdom