Status:
COMPLETED
Randomised Ischaemic Mitral Evaluation (RIME) Trial
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Department of Health, United Kingdom
British Heart Foundation
Conditions:
Mitral Regurgitation
Coronary Artery Disease
Eligibility:
All Genders
Phase:
EARLY_PHASE1
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). Pa...
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. Patient...
Eligibility Criteria
Inclusion
- Patients undergoing CABG.
- Patients with moderate functional ischaemic mitral regurgitation without leaflet prolapse.
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00413998
Start Date
January 1 2007
End Date
August 1 2012
Last Update
March 28 2023
Active Locations (9)
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1
1st Dept of Cardiothoracic Surgery, Medical University of Silesia
Katowice, Poland
2
Blackpool Victoria Hospital
Blackpool, Lancashire, United Kingdom, FY3 8NR
3
Bristol Heart Institute
Bristol, United Kingdom
4
Harefield Hospital
Harefield, United Kingdom, UB9 6UJ