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| ID | Type | Description | Link |
|---|---|---|---|
| NIHR Portfolio ID 4129 | Other Grant/Funding Number | National Institute for Health Research |
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| Name | Class |
|---|---|
| Department of Health, United Kingdom | OTHER_GOV |
| British Heart Foundation | OTHER |
| British Medical Association | OTHER |
| Royal Brompton & Harefield NHS Foundation Trust |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CABG + Mitral valve repair | Experimental |
| |
| CABG only | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CABG + Mitral valve annuloplasty | Procedure | Patients will receive a mitral annuloplasty ring in addition to coronary artery bypass grafting. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional capacity | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular volumes | 1 year | |
| Mitral regurgitation grade | 1 year | |
| Neurohormonal levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John R Pepper, MChir, FRCS | Royal Brompton & Harefield NHS Foundation Trust | Study Chair |
| Marcus Flather, MBBS, FRCP | Royal Brompton Hospital NHS Trust, London | Principal Investigator |
| K. M. John Chan, FRCS CTh | Royal Brompton Hospital NHS Trust, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Dept of Cardiothoracic Surgery, Medical University of Silesia | Katowice | Poland | ||||
| Blackpool Victoria Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19410679 | Background | 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. | |
| 19102740 | Background | 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. |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
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| ID | Term |
|---|---|
| D058386 | Mitral Valve Annuloplasty |
| ID | Term |
|---|---|
| D058385 | Cardiac Valve Annuloplasty |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| OTHER |
| Imperial College Healthcare NHS Trust | OTHER |
| University Hospitals, Leicester | OTHER |
| Medical University of Silesia | OTHER |
| University Hospitals Bristol and Weston NHS Foundation Trust | OTHER |
| Blackpool Victoria Hospital | OTHER |
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| CABG | Procedure | Patients will undergo coronary artery bypass grafting alone. |
|
| 1 year |
| 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 |
| 23136163 | Result | 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. |
| D017202 |
| Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D019616 | Thoracic Surgical Procedures |