Clinical trial NCT00413998: Randomised Ischaemic Mitral Evaluation (RIME) Trial
Official title: Randomized Evaluation of Mitral Annuloplasty During Coronary Artery Bypass Grafting for Moderate Functional Ischaemic Mitral Regurgitation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Mitral Regurgitation
Coronary Artery Disease
Keywords: Functional ischaemic mitral regurgitation
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Department of Health, United Kingdom
name: British Heart Foundation
name: British Medical Association
name: Royal Brompton & Harefield NHS Foundation Trust
name: Imperial College Healthcare NHS Trust
name: University Hospitals, Leicester
name: Medical University of Silesia
name: University Hospitals Bristol and Weston NHS Foundation Trust
name: Blackpool Victoria Hospital
First posted: 2006-12-20
Enrollment: 73
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional capacity
timeFrame: 1 year
Secondary outcomes:
measure: Left ventricular volumes
timeFrame: 1 year
measure: Mitral regurgitation grade
timeFrame: 1 year
measure: Neurohormonal levels
timeFrame: 1 year
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: 1st Dept of Cardiothoracic Surgery, Medical University of Silesia
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
state: Lancashire
city: Bristol
country: United Kingdom
facility: Bristol Heart Institute
city: Harefield
country: United Kingdom
facility: Harefield Hospital
city: Leicester
country: United Kingdom
facility: Glenfield Hospital, Leicester
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: London
country: United Kingdom
facility: Heart Hospital, University College Hospital
city: London
country: United Kingdom
facility: St. Mary's Hospital
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: John R Pepper, MChir, FRCS
role: STUDY_CHAIR
affiliation: Royal Brompton Hospital NHS Trust, London
name: Marcus Flather, MBBS, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Brompton Hospital NHS Trust, London
name: K. M. John Chan, FRCS CTh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Chan 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.
citation: Chan 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.