Condition category
Circulatory System
Date applied
10/03/2011
Date assigned
28/06/2011
Last edited
28/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Denis Bouchard

ORCID ID

Contact details

Montreal Heart Institute
Rue Belanger 5000
Montreal
H1T 1C8
Canada
andre.denis.bouchard@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Moderate functional ischemic mitral regurgitation patients randomised to Coronary Artery Bypass Graft (CABG) versus CABG and down-sized ring annuloplasty

Acronym

Study hypothesis

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

Committee of Research Ethics and Development of New Technologies, Montreal Heart Institute, Montreal, Qc, Canada. 2 May 2002, ref: CÉRDNT 01-087

Study design

Randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in we format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

28/06/2002

Overall trial end date

01/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Moderate (grade 2+) functional ischemic mitral regurgitation in patients undergoing coronary artery bypass grafing

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

58

Participant exclusion criteria

1. Papillary muscle rupture
2. Concomitant aortic valve surgery
3. Life expectancy less than 12 months
4. Creatinine > 200 µmol/l

Recruitment start date

28/06/2002

Recruitment end date

01/07/2011

Locations

Countries of recruitment

Canada

Trial participating centre

Montreal Heart Institute
Montreal
H1T 1C8
Canada

Sponsor information

Organisation

Montreal Heart Institute (Canada)

Sponsor details

5000 Rue Belanger
Montreal
H1T 1C8
Canada
+1 514 376 3330
andre.denis.bouchard@gmail.com

Sponsor type

Hospital/treatment centre

Website

http://www.icm-mhi.org/en/index.html

Funders

Funder type

Hospital/treatment centre

Funder name

Montreal Heart Institute, Quebec (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes