A randomised trial of conventional and off-pump coronary artery bypass grafting (CABG) on myocardial injury as assessed by multi-parametric magnetic resonance imaging (MRI) and specific biochemical markers.

ISRCTN	ISRCTN53238725
DOI	https://doi.org/10.1186/ISRCTN53238725
Secondary identifying numbers	N0176113611

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 30/08/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof David P Taggart
Scientific

Department of Cardiovascular Medicine
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Phone	+44 (0)1865 222086
Email	david.taggart@orh.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	1. To quantify both functional and irreversible myocardial injury after CABG, with and without cardiopulmonary bypass (CPB) using multiparametric cardiac MRI at the highest spatial resolution. 2. To quantify the pathophysiological significance of bio chemically defined myocardial injury with MRI determined grams of myocardial tissue loss after CABG, with and without CPB. 3. To define the power of these new MRI indices to predict functional recovery at 6 months post-surgical revascularisation.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Coronary artery bypass grafting (CABG)
Intervention	Patients will be randomised to receive conventional CABG or off-pump CABG (OPCABG).
Intervention type	Procedure/Surgery
Primary outcome measure	1. Number and percentage of new left ventricular (LV) wall segments that are assessed as non viable by late Gd-DTPA MR imaging in both the conventional CABG and OPCABG groups 2. The distribution (regional versus global) of new non viable LV segments in both the conventional CABG and OPCABG groups 3. The extent of post operative rise in biochemical cardiac markers will be compared in the two surgical groups and will be correlated with the functional cardiac MR assessment.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/06/2002
Completion date	30/09/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	90 (70 study patients and 20 post MI patients)
Key inclusion criteria	90 patients undergoing CABG
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/06/2002
Date of final enrolment	30/09/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Cardiovascular Medicine

Oxford
OX3 9DU
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Oxford Radcliffe Hospitals NHS Trust (UK) - Departmental resources

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	27/01/2004		Yes	No