Does remote ischaemic preconditioning reduce heart and cerebral damage following carotid endarterectomy? A randomised controlled trial

ISRCTN	ISRCTN98544942
DOI	https://doi.org/10.1186/ISRCTN98544942
Protocol serial number	N/A
Sponsor	Cambridge University Hospitals NHS Foundation Trust (UK)
Funder	Cambridge Vascular Research Fund (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Michael Gaunt
Scientific

Consultant Vascular Surgeon
Level 7
Box 201
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0)123 212246
Email	michael.gaunt@addenbrookes.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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.
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	Carotid stenosis
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	70
Key inclusion criteria	Patients undergoing elective carotid endarterectomy.
Key exclusion criteria	1. Patients with an ankle-brachial pressure index less than 0.7 2. Patients who have undergone previous lower limb amputation 3. Blind patients
Date of first enrolment	01/01/2006
Date of final enrolment	01/01/2007

Consultant Vascular Surgeon

Cambridge
CB2 2QQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2010		Yes	No