Randomised Ischaemic Mitral Evaluation (RIME) Trial
This study is ongoing, but not recruiting participants.
Sponsor:
Imperial College London
Collaborators:
Department of Health, United Kingdom
British Heart Foundation
British Medical Association
Royal Brompton & Harefield NHS Foundation Trust
Imperial College Healthcare NHS Trust
University Hospitals, Leicester
Medical University of Silesia
United Bristol Healthcare NHS Trust
Blackpool, Flyde and Wyre Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00413998
First received: December 19, 2006
Last updated: March 22, 2012
Last verified: March 2012
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Evaluation of Mitral Annuloplasty During Coronary Artery Bypass Grafting for Moderate Functional Ischaemic Mitral Regurgitation. |
Resource links provided by NLM:
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: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Procedure: Mitral annuloplasty
Patients will receive a mitral annuloplasty ring in addition to coronary artery bypass grafting.
|
| Active Comparator: 2 |
Procedure: Coronary Artery Bypass Graft Surgery
Patients will undergo coronary artery bypass grafting alone.
|
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| 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
Locations
| Poland | |
| 1st Dept of Cardiothoracic Surgery, Medical University of Silesia | |
| Katowice, Poland | |
| United Kingdom | |
| Blackpool Victoria Hospital | |
| Blackpool, Lancashire, United Kingdom, FY3 8NR | |
| Bristol Heart Institute | |
| Bristol, United Kingdom | |
| Harefield Hospital | |
| Harefield, United Kingdom, UB9 6UJ | |
| Glenfield Hospital, Leicester | |
| Leicester, United Kingdom, LE3 9QP | |
| Hammersmith Hospital | |
| London, United Kingdom, W12 0HS | |
| Heart Hospital, University College Hospital | |
| London, United Kingdom, W1G 8PH | |
| Royal Brompton Hospital | |
| London, United Kingdom, SW3 6NP | |
| St. Mary's Hospital | |
| London, United Kingdom, W2 1NY | |
Sponsors and Collaborators
Imperial College London
Department of Health, United Kingdom
British Heart Foundation
British Medical Association
Royal Brompton & Harefield NHS Foundation Trust
Imperial College Healthcare NHS Trust
University Hospitals, Leicester
Medical University of Silesia
United Bristol Healthcare NHS Trust
Blackpool, Flyde and Wyre Hospitals NHS Foundation Trust
Investigators
| 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 |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT00413998 History of Changes |
| Other Study ID Numbers: | 2006HS020B, NIHR Portfolio ID 4129 |
| Study First Received: | December 19, 2006 |
| Last Updated: | March 22, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Imperial College London:
|
Functional ischaemic mitral regurgitation |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Mitral Valve Insufficiency Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Heart Valve Diseases |
ClinicalTrials.gov processed this record on May 23, 2013