Randomised Ischaemic Mitral Evaluation (RIME) Trial
RIME
Randomized Evaluation of Mitral Annuloplasty During Coronary Artery Bypass Grafting for Moderate Functional Ischaemic Mitral Regurgitation.
2 other identifiers
interventional
73
2 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jan 2007
Longer than P75 for early_phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2006
CompletedFirst Posted
Study publicly available on registry
December 20, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedMarch 28, 2023
March 1, 2023
5.3 years
December 19, 2006
March 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional capacity
1 year
Secondary Outcomes (3)
Left ventricular volumes
1 year
Mitral regurgitation grade
1 year
Neurohormonal levels
1 year
Study Arms (2)
CABG + Mitral valve repair
EXPERIMENTALCABG only
ACTIVE COMPARATORInterventions
Patients will receive a mitral annuloplasty ring in addition to coronary artery bypass grafting.
Eligibility Criteria
You may qualify if:
- Patients undergoing CABG.
- Patients with moderate functional ischaemic mitral regurgitation without leaflet prolapse.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- Department of Health, United Kingdomcollaborator
- British Heart Foundationcollaborator
- British Medical Associationcollaborator
- Royal Brompton & Harefield NHS Foundation Trustcollaborator
- Imperial College Healthcare NHS Trustcollaborator
- University Hospitals, Leicestercollaborator
- Medical University of Silesiacollaborator
- University Hospitals Bristol and Weston NHS Foundation Trustcollaborator
- Blackpool Victoria Hospitalcollaborator
Study Sites (9)
1st Dept of Cardiothoracic Surgery, Medical University of Silesia
Katowice, Poland
Blackpool Victoria Hospital
Blackpool, Lancashire, FY3 8NR, United Kingdom
Bristol Heart Institute
Bristol, United Kingdom
Harefield Hospital
Harefield, UB9 6UJ, United Kingdom
Glenfield Hospital, Leicester
Leicester, LE3 9QP, United Kingdom
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
Hammersmith Hospital
London, W12 0HS, United Kingdom
Heart Hospital, University College Hospital
London, W1G 8PH, United Kingdom
St. Mary's Hospital
London, W2 1NY, United Kingdom
Related Publications (3)
Chan KM, Amirak E, Zakkar M, Flather M, Pepper JR, Punjabi PP. Ischemic mitral regurgitation: in search of the best treatment for a common condition. Prog Cardiovasc Dis. 2009 May-Jun;51(6):460-71. doi: 10.1016/j.pcad.2008.08.006.
PMID: 19410679BACKGROUNDChan KM, Wage R, Symmonds K, Rahman-Haley S, Mohiaddin RH, Firmin DN, Pepper JR, Pennell DJ, Kilner PJ. Towards comprehensive assessment of mitral regurgitation using cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2008 Dec 22;10(1):61. doi: 10.1186/1532-429X-10-61.
PMID: 19102740BACKGROUNDChan KM, Punjabi PP, Flather M, Wage R, Symmonds K, Roussin I, Rahman-Haley S, Pennell DJ, Kilner PJ, Dreyfus GD, Pepper JR; RIME Investigators. Coronary artery bypass surgery with or without mitral valve annuloplasty in moderate functional ischemic mitral regurgitation: final results of the Randomized Ischemic Mitral Evaluation (RIME) trial. Circulation. 2012 Nov 20;126(21):2502-10. doi: 10.1161/CIRCULATIONAHA.112.143818. Epub 2012 Nov 7.
PMID: 23136163RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John R Pepper, MChir, FRCS
Royal Brompton & Harefield NHS Foundation Trust
- PRINCIPAL INVESTIGATOR
Marcus Flather, MBBS, FRCP
Royal Brompton Hospital NHS Trust, London
- PRINCIPAL INVESTIGATOR
K. M. John Chan, FRCS CTh
Royal Brompton Hospital NHS Trust, London
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2006
First Posted
December 20, 2006
Study Start
January 1, 2007
Primary Completion
April 1, 2012
Study Completion
August 1, 2012
Last Updated
March 28, 2023
Record last verified: 2023-03