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ISRCTN
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ISRCTN46552265
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ClinicalTrials.gov identifier
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Public title
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Arterial Revascularisation Trial - A randomised trial to compare survival following bilateral versus single internal mammary artery (IMA) grafting in coronary revascularisation
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Scientific title
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Acronym
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ART
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Serial number at source
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G0200390
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Study hypothesis
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The main objective is to assess whether the use of both IMA during coronary artery bypass graft (CABG) surgery improves survival and reduces the need for further interventions over that observed with a single IMA.
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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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Australia, Brazil, Poland, United Kingdom, Europe
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Disease/condition/study domain
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Cardiovascular
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Participants - inclusion criteria
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Coronary artery bypass graft (CABG) patients with multi-vessel coronary artery disease (including urgent and off pump CABG patients)
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Participants - exclusion criteria
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1. Single graft
2. Redo CABG
3. Evolving myocardial infarction
4. Concomitant valve surgery
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Anticipated start date
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01/07/2004
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Anticipated end date
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30/06/2014
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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3000
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Interventions
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Patients will be randomised to single internal mammary artery (SIMA) grafting or bilateral internal mammary artery (BIMA) grafting with supplemental vein or radial artery grafts as required.
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Primary outcome measure(s)
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Survival
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Secondary outcome measure(s)
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1. Cause-specific mortality
2. 30 day mortality
3. Need for re-intervention by percutaneous coronary intervention or redo surgery
other clinical events
4. Quality of Life Evaluation (SF36, Rose and EuroQol)
5. Cost-effectiveness
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Sources of funding
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ART is funded jointly by a grant from the British Heart Foundation (UK) (SP/03/001) and a grant from the Medical Research Council (UK) (G0200390)
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Trial website
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http://www.herc.ox.ac.uk/research/evaluations/art
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Publications
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1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16573820
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20805116
3. 2011 assessment of data quality in http://www.ncbi.nlm.nih.gov/pubmed/21943128
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Contact name
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Mr
David
Taggart
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Address
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Department of Cardiothoracic Surgery
The John Radcliffe
Headley Way
Headington
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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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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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Sponsor website:
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http://www.ox.ac.uk
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Date applied
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19/10/2004
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Last edited
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07/02/2012
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Date ISRCTN assigned
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17/01/2005
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