Do patients undergoing coronary artery bypass grafting benefit from concomitant mitral valve surgery?

ISRCTN	ISRCTN33897799
DOI	https://doi.org/10.1186/ISRCTN33897799
Protocol serial number	N/A
Sponsor	Montreal Heart Institute (Canada)
Funder	Montreal Heart Institute, Quebec (Canada)

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

Dr Denis Bouchard
Scientific

Montreal Heart Institute
Rue Belanger 5000
Montreal
H1T 1C8
Canada

Email	andre.denis.bouchard@gmail.com

Primary study design	Interventional
Study design	Randomised controlled study
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	1. Mitral regurgitation severity 2. Left ventricular geometry and function 3. Evaluated 6 and 12 months by echocardiography
Key secondary outcome measure(s)	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)
Completion date	01/07/2011

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Montreal Heart Institute

Montreal
H1T 1C8
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes