Randomised Ischaemic Mitral Evaluation (RIME) Trial

This study is currently recruiting participants.

Verified by Imperial College London, September 2008

Sponsors and Collaborators:	Imperial College London Department of Health, United Kingdom British Heart Foundation British Medical Association Royal Brompton Hospital NHS Trust Hammersmith Hospitals NHS Trust St Mary's NHS Trust King's College Hospital NHS Trust Glasgow Royal Infirmary Golden Jubilee National Hospital University Hospitals, Leicester Nottingham University Hospitals NHS Trust Medical University of Silesia
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00413998

Purpose

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.

Condition	Intervention	Phase
Mitral Regurgitation Coronary Artery Disease	Procedure: Mitral annuloplasty Procedure: Coronary Artery Bypass Graft Surgery	Phase III

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Evaluation of Mitral Annuloplasty During Coronary Artery Bypass Grafting for Moderate Functional Ischaemic Mitral Regurgitation.

Further study details as provided by Imperial College London:

Primary Outcome Measures:

Functional capacity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Health related quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Cardiac function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Mitral regurgitation grade [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Neurohormonal levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Procedure: Mitral annuloplasty Patients will receive a mitral annuloplasty ring in addition to coronary artery bypass grafting.
2: Active Comparator	Procedure: Coronary Artery Bypass Graft Surgery Patients will undergo coronary artery bypass grafting alone.

Detailed Description:

100 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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients undergoing CABG.
Patients with moderate functional ischaemic mitral regurgitation without leaflet prolapse.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413998

Contacts

Contact: K. M. John Chan, FRCS CTh

+44 207 351 8530

John.Chan98@imperial.ac.uk

Locations

Poland
1st Dept of Cardiothoracic Surgery, Medical University of Silesia	Recruiting
Katowice, Poland
Principal Investigator: Andrzej Bochenek, MD
United Kingdom
Royal Brompton Hospital	Recruiting
London, United Kingdom, SW3 6NP
Principal Investigator: John R Pepper, MChir, FRCS
Harefield Hospital	Recruiting
Harefield, United Kingdom, UB9 6UJ
Principal Investigator: Gilles D Dreyfus, MD, FRCS
Hammersmith Hospital	Recruiting
London, United Kingdom, W12 0HS
Principal Investigator: Prakash P Punjabi, FRCS CTh
St. Mary's Hospital	Recruiting
London, United Kingdom, W2 1NY
Principal Investigator: Darrel Francis, MD, MRCP
Heart Hospital, University College Hospital	Not yet recruiting
London, United Kingdom, W1G 8PH
Principal Investigator: John Yap, MD, FRCS CTh
Glenfield Hospital, Leicester	Recruiting
Leicester, United Kingdom, LE3 9QP
Principal Investigator: Tom J Spyt, MD, FRCS CTh
Nottingham City Hospital	Not yet recruiting
Nottingham, United Kingdom, NG5 1PB
Principal Investigator: Surendra K Naik, PhD, FRCS
King's College Hospital	Recruiting
London, United Kingdom, SE5 9RS
Principal Investigator: Olaf Wendler, PhD, FRCS
Golden Jubilee National Hospital	Recruiting
Glasgow, United Kingdom, G81 4HX
Principal Investigator: Andrew Murday, FRCS
Glasgow Royal Infirmary	Not yet recruiting
Glasgow, United Kingdom, G4 0SF
Principal Investigator: Andrew Murday, FRCS

Sponsors and Collaborators

Imperial College London

Department of Health, United Kingdom

British Heart Foundation

British Medical Association

Royal Brompton Hospital NHS Trust

Hammersmith Hospitals NHS Trust

St Mary's NHS Trust

King's College Hospital NHS Trust

Glasgow Royal Infirmary

Golden Jubilee National Hospital

University Hospitals, Leicester

Nottingham University Hospitals NHS Trust

Medical University of Silesia

Investigators

Study Chair:	John R Pepper, MChir, FRCS	Royal Brompton Hospital NHS 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

More Information

Responsible Party:	Imperial College London ( Mr Gary Roper, Research Governance Manager, )
Study ID Numbers:	2006HS020B, NIHR Portfolio ID 4129
Study First Received:	December 19, 2006
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00413998
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:

Functional ischaemic mitral regurgitation

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Arteriosclerosis
Ischemia
Coronary Artery Disease
Heart Valve Diseases
Mitral Valve Insufficiency

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009