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Randomised Ischaemic Mitral Evaluation (RIME) Trial

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00413998
Acronym
RIME
Enrollment
73
Registered
2006-12-20
Start date
2007-01-31
Completion date
2012-08-31
Last updated
2023-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Mitral Regurgitation

Keywords

Functional ischaemic mitral regurgitation

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.

Interventions

PROCEDURECABG + Mitral valve annuloplasty

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

PROCEDURECABG

Patients will undergo coronary artery bypass grafting alone.

Sponsors

Department of Health, United Kingdom
CollaboratorOTHER_GOV
British Heart Foundation
CollaboratorOTHER
British Medical Association
CollaboratorOTHER
Royal Brompton & Harefield NHS Foundation Trust
CollaboratorOTHER
Imperial College Healthcare NHS Trust
CollaboratorOTHER
University Hospitals, Leicester
CollaboratorOTHER
Medical University of Silesia
CollaboratorOTHER
University Hospitals Bristol and Weston NHS Foundation Trust
CollaboratorOTHER
Blackpool Victoria Hospital
CollaboratorOTHER
Imperial College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Functional capacity1 year

Secondary

MeasureTime frame
Left ventricular volumes1 year
Mitral regurgitation grade1 year
Neurohormonal levels1 year

Countries

Poland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026