Do patients undergoing coronary artery bypass grafting benefit from concomitant mitral valve surgery?
| ISRCTN | ISRCTN33897799 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33897799 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/03/2011
- Registration date
- 28/06/2011
- Last edited
- 28/06/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Denis Bouchard
Scientific
Scientific
Montreal Heart Institute
Rue Belanger 5000
Montreal
H1T 1C8
Canada
| andre.denis.bouchard@gmail.com |
Study information
| Study design | Randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in we format, please use the contact details below to request a patient information sheet |
| Scientific title | Moderate functional ischemic mitral regurgitation patients randomised to Coronary Artery Bypass Graft (CABG) versus CABG and down-sized ring annuloplasty |
| Study objectives | In patients with moderate functional ischemic mitral regurgitation, CABG combined with down-sized mitral ring annuloplasty improves freedom from persistent or recurrent mitral regurgitation compared with CABG alone |
| Ethics approval(s) | Committee of Research Ethics and Development of New Technologies, Montreal Heart Institute, Montreal, Qc, Canada. 2 May 2002, ref: CÉRDNT 01-087 |
| Health condition(s) or problem(s) studied | Functional ischemic mitral regurgitation |
| Intervention | 1. Intervention group: Coronary artery bypass grafting + down-sized mitral ring annuloplasty 2. Control group: Coronary artery bypass grafting 3. Follow-up: Echocardiography 6 months, 1 year |
| Intervention type | Other |
| Primary outcome measure | 1. Mitral regurgitation severity 2. Left ventricular geometry and function 3. Evaluated 6 and 12 months by echocardiography |
| Secondary outcome measures | 1. Mortality: in hospital and 5 years 2. New York Heart Association (NYHA) class: evaluated at 5 years 3. The following outcomes are measured 12 months postop 3.1. 6-min walk test 3.2. Minnesota questionnaire score 3.3. Brain Natriuretic Peptide (BNP) |
| Overall study start date | 28/06/2002 |
| Completion date | 01/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 58 |
| Key inclusion criteria | Moderate (grade 2+) functional ischemic mitral regurgitation in patients undergoing coronary artery bypass grafing |
| Key exclusion criteria | 1. Papillary muscle rupture 2. Concomitant aortic valve surgery 3. Life expectancy less than 12 months 4. Creatinine > 200 µmol/l |
| Date of first enrolment | 28/06/2002 |
| Date of final enrolment | 01/07/2011 |
Locations
Countries of recruitment
- Canada
Study participating centre
Montreal Heart Institute
Montreal
H1T 1C8
Canada
H1T 1C8
Canada
Sponsor information
Montreal Heart Institute (Canada)
Hospital/treatment centre
Hospital/treatment centre
5000 Rue Belanger
Montreal
H1T 1C8
Canada
| Phone | +1 514 376 3330 |
|---|---|
| andre.denis.bouchard@gmail.com | |
| Website | http://www.icm-mhi.org/en/index.html |
"ROR" |
https://ror.org/03vs03g62 |
Funders
Funder type
Hospital/treatment centre
Montreal Heart Institute, Quebec (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
