Randomised Ischaemic Mitral Evaluation (RIME) Trial
NCT00413998 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2023-03-28
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.
Conditions
- Mitral Regurgitation
- Coronary Artery Disease
Interventions
- PROCEDURE
-
CABG + Mitral valve annuloplasty
Patients will receive a mitral annuloplasty ring in addition to coronary artery bypass grafting.
- PROCEDURE
-
CABG
Patients will undergo coronary artery bypass grafting alone.
Sponsors & Collaborators
-
Department of Health, United Kingdom
collaborator OTHER_GOV -
British Heart Foundation
collaborator OTHER -
British Medical Association
collaborator OTHER -
Royal Brompton & Harefield NHS Foundation Trust
collaborator OTHER -
Imperial College Healthcare NHS Trust
collaborator OTHER -
University Hospitals, Leicester
collaborator OTHER -
Medical University of Silesia
collaborator OTHER -
University Hospitals Bristol and Weston NHS Foundation Trust
collaborator OTHER -
Blackpool Victoria Hospital
collaborator OTHER -
Imperial College London
lead OTHER
Principal Investigators
-
John R Pepper, MChir, FRCS · Royal Brompton & Harefield NHS Foundation Trust
-
Marcus Flather, MBBS, FRCP · Royal Brompton Hospital NHS Trust, London
-
K. M. John Chan, FRCS CTh · Royal Brompton Hospital NHS Trust, London
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-01-31
- Primary Completion
- 2012-04-30
- Completion
- 2012-08-31
Countries
- Poland
- United Kingdom
Study Locations
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