Contact information
Type
Scientific
Primary contact
Prof David P Taggart
ORCID ID
Contact details
Department of Cardiovascular Medicine
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 222086
david.taggart@orh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0176113611
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Surgery: Coronary artery bypass grafting (CABG)
Intervention
Patients will be randomised to receive conventional CABG or off-pump CABG (OPCABG).
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/06/2002
Overall trial end date
30/09/2003
Reason abandoned
Eligibility
Participant inclusion criteria
90 patients undergoing CABG
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
90 (70 study patients and 20 post MI patients)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/06/2002
Recruitment end date
30/09/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Cardiovascular Medicine
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Oxford Radcliffe Hospitals NHS Trust (UK) - Departmental resources
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
2004 results in: http://www.ncbi.nlm.nih.gov/pubmed/14732755
Publication citations
-
Results
Selvanayagam JB, Petersen SE, Francis JM, Robson MD, Kardos A, Neubauer S, Taggart DP, Effects of off-pump versus on-pump coronary surgery on reversible and irreversible myocardial injury: a randomized trial using cardiovascular magnetic resonance imaging and biochemical markers., Circulation, 2004, 109, 3, 345-350, doi: 10.1161/01.CIR.0000109489.71945.BD.