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 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/12/2005
- Registration date
- 13/01/2006
- Last edited
- 17/08/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Mr Michael Gaunt
Scientific
Scientific
Consultant Vascular Surgeon
Level 7
Box 201
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)123 212246 |
|---|---|
| michael.gaunt@addenbrookes.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| 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(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. |
| 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 |
| Primary outcome measure | 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 study start date | 01/01/2006 |
| Overall study end date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 70 |
| Participant inclusion criteria | Patients undergoing elective carotid endarterectomy. |
| 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
- England
- United Kingdom
Study participating centre
Consultant Vascular Surgeon
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
R&D Office
Box 146
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
England
United Kingdom
| Phone | +44 (0)1223 274486 |
|---|---|
| joanne.heritage@addenbrookes.nhs.uk | |
| Website | http://www.addenbrookes.nhs.uk |
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Charity
Cambridge Vascular Research Fund (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2010 | Yes | No |
