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ISRCTN
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ISRCTN20472718
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ClinicalTrials.gov identifier
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Public title
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Effects of off pump versus on pump coronary surgery on reversible and irreversible myocardial injury: a randomised trial using cardiovascular magnetic resonance imaging and biochemical markers
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Scientific title
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Acronym
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N/A
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Serial number at source
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066216
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Study hypothesis
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Using Cardiovascular Magnetic Resonance imaging (CMR), we compared the extent of peri-operative myocardial reversible injury (myocardial stunning) and irreversible injury (myocardial necrosis) in patients undergoing multi-vessel Coronary Artery Bypass Graft surgery (CABG) with and without cardiopulmonary bypass, in a single center randomised trial.
To our knowledge, this is the first such study using cine and contrast-enhanced CMR. Furthermore, we correlated these CMR findings with the changes in post operative cardiac Troponin I. Our primary hypothesis was that off pump surgery results in reduced myocardial stunning (as measured by cine MRI) in the early post-operative period when compared to ON-pump CABG (ONCABG) surgery. We further hypothesised that off pump surgery is superior to ONCABG with regards to the extent of permanent myocardial damage and that post-operative myocardial enzyme release reflects myonecrosis.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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CABG surgery
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Participants - inclusion criteria
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1. Aged less than 75 years
2. Isolated coronary grafting
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Participants - exclusion criteria
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1. Age greater than 75 years (ten patients)
2. Ppre-existing Left Ventricular (LV) dysfunction (ejection fraction less than 20% by echocardiogram; four patients)
3. Involvement in other clinical trials (ten patients)
4. Typical MRI contraindications (e.g. pacemaker, severe claustrophobia etc.; total of nine patients)
5. Baseline creatinine more than 200 µmol/L (two patients)
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Anticipated start date
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01/05/2002
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Anticipated end date
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01/10/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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50 - Recruitment finished on 01/04/2003
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Interventions
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Single centre randomised trial comparing off pump (beating heart) versus conventional bypass coronary artery surgery.
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Primary outcome measure(s)
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1. Left ventricular function at one week post-op
2. LV function at six months post-op
3. Myocardial necrosis post-op
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 066216)
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18981306
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Contact name
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Mr
Joseph Brindaban
Selvanayangam
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Address
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John Radcliffe Hospital
MRS Building
University of Oxford Clinical Magnetic Resonance Research Centre
Headley Way
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City/town
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Oxford
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Zip/Postcode
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OX3 9DU
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Country
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United Kingdom
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Tel
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+44 (0)1865 221867
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Fax
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+44 (0)1865 221867
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Email
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joseph.selvanayagam@cardiov.ox.ac.uk
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Sponsor
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University of Oxford (UK)
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Address
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University Offices
Wellington Square
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City/town
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Oxford
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Zip/Postcode
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OX1 2JD
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Country
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United Kingdom
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Tel
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+44 (0)1865 270143
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Fax
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+44 (0)1865 280467
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Email
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research.services@admin.ox.ac.uk
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Sponsor website:
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http://www.ox.ac.uk
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Date applied
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22/07/2005
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Last edited
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16/06/2011
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Date ISRCTN assigned
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22/07/2005
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