Condition category
Circulatory System
Date applied
15/12/2005
Date assigned
13/01/2006
Last edited
17/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Michael Gaunt

ORCID ID

Contact details

Consultant Vascular Surgeon
Level 7
Box 201
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)123 212246
michael.gaunt@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

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.

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

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

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2006

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing elective carotid endarterectomy.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

Participant 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

Recruitment start date

01/01/2006

Recruitment end date

01/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Vascular Surgeon
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

R&D Office
Box 146
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 274486
joanne.heritage@addenbrookes.nhs.uk

Sponsor type

Government

Website

http://www.addenbrookes.nhs.uk

Funders

Funder type

Charity

Funder name

Cambridge Vascular Research Fund (UK)

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20484064

Publication citations

  1. Results

    Walsh SR, Nouraei SA, Tang TY, Sadat U, Carpenter RH, Gaunt ME, Remote ischemic preconditioning for cerebral and cardiac protection during carotid endarterectomy: results from a pilot randomized clinical trial., Vasc Endovascular Surg, 2010, 44, 6, 434-439, doi: 10.1177/1538574410369709.

Additional files

Editorial Notes