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ISRCTN
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ISRCTN98544942
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ClinicalTrials.gov identifier
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Public title
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Does remote ischaemic preconditioning reduce heart and cerebral damage following carotid endarterectomy? A randomised controlled trial
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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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N/A
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Study hypothesis
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Carotid endarterectomy is associated with a significant risk of stroke or myocardial infarction. This trial aims to determine whether remote ischaemic preconditioning reduces subclinical cerebral and myocardial damage among patients undergoing carotid endarterectomy.
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Lay summary
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Ethics approval
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Reviewed and approved by an NHS Research Ethics Committee November 2005. The committee will review the results of the first 12 block randomised patients to determine if the trial should proceed any further.
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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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Carotid stenosis
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Participants - inclusion criteria
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Patients undergoing elective carotid endarterectomy.
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Participants - exclusion criteria
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1. Patients with an ankle-brachial pressure index less than 0.7
2. Patients who have undergone previous lower limb amputation
3. Blind patients
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Anticipated start date
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01/01/2006
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Anticipated end date
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01/01/2007
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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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70
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Interventions
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Patients randomised to undergo ischaemic preconditioning will have a thigh cuff inflated on one leg until flow in the pedal arteries disappears. After five minutes have elapsed, the cuff will be moved to the opposite thigh. The cycle will be repeated so that each leg has two five minute periods of ischaemia followed by five minutes of reperfusion.
Control: no ischaemic preconditioning.
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Primary outcome measure(s)
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Primary neurological outcome: proportion of patients developing a significant change in saccadic latency as determined by quantitative oculometry.
Cardiac outcome: serial troponin I levels post-operatively.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cambridge Vascular Research Fund (UK)
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20484064
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Contact name
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Mr
Michael
Gaunt
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Address
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Consultant Vascular Surgeon
Level 7
Box 201
Addenbrooke's Hospital
Hills Road
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City/town
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Cambridge
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Zip/Postcode
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CB2 2QQ
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Country
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United Kingdom
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Tel
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+44 (0)123 212246
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Email
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michael.gaunt@addenbrookes.nhs.uk
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Sponsor
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Cambridge University Hospitals NHS Foundation Trust (UK)
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Address
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R&D Office
Box 146
Addenbrooke's Hospital
Hills Road
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City/town
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Cambridge
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Zip/Postcode
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CB2 2QQ
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Country
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United Kingdom
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Tel
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+44 (0)1223 274486
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Email
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joanne.heritage@addenbrookes.nhs.uk
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Sponsor website:
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http://www.addenbrookes.nhs.uk
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Date applied
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15/12/2005
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Last edited
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17/08/2010
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Date ISRCTN assigned
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13/01/2006
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