Validation of a Purine Biosensor in Detecting Acute Cerebral Ischaemia: Carotid Endarterectomy Model in SMARTChip (CEMS)
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|ClinicalTrials.gov Identifier: NCT02545166|
Recruitment Status : Active, not recruiting
First Posted : September 9, 2015
Last Update Posted : July 6, 2017
|Condition or disease|
Blood purine levels have been shown to be associated with ischaemic brain conditions. Studies have consistently shown that levels of purines in the blood rise rapidly when oxygen flow to the brain is reduced (hypoxia) and returns to the pre-hypoxic level within 30 minutes upon restoring the oxygen supply. There is therefore the potential for blood purine levels to be used to diagnose strokes more quickly. The investigators have undertaken a programme of work to develop, test and refine a purine biosensor, called SMARTChip. This is a prospective observational study to test the sensitivity of SMARTChip in detecting fluctuations in blood purine levels throughout various stages of carotid endarterectomy. Carotid endarterectomy patients have been chosen for this study because the procedure provides a controlled normoxic and hypoxic brain environment without compromising patient safety and has clear and systematic technical steps which will ensure reliable and robust data. The investigators will test the pre-, peri- and post-operative blood purine levels in 40 patients undergoing carotid endarterectomy at University Hospitals Coventry and Warwickshire NHS Trust, University Hospitals of North Midlands NHS Trust and University Hospitals Birmingham NHS Foundation Trust.
In this study the investigators will also test the hypothesis that purine levels may be predictive of future stroke risk. In a previous study carried out by the trial team patients undergoing carotid endarterectomy, a group that is by definition at increased risk of stroke, were found to have significantly higher purine levels than would be expected in a healthy population. Therefore a case-control study, including 80 patients recruited from the day surgery schedules at the three hospitals as controls and the 40 CEA patients recruited for the observational study as cases, will be undertaken alongside the observational study to assess whether purine levels differ systematically in CEA patients and controls.
|Study Type :||Observational|
|Actual Enrollment :||153 participants|
|Official Title:||Validation of a Purine Biosensor in Detecting Acute Cerebral Ischaemia: Carotid Endarterectomy Model in SMARTChip|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Carotid endarterectomy patients
40 male and female patients, aged 18 years and over, scheduled for carotid endarterectomy. Fasted pre-operative (arterial and capillary), peri-operative (arterial) and 1-hour and 24-hour post-operative (arterial) blood samples will be collected and analysed for serum purine concentration.
80 age and sex-matched control patients scheduled for non-vascular, non-oncological day surgery. A single pre-operative fasted capillary (finger-prick) blood sample will be collected and analysed for serum purine concentration.
- Pre-, peri-, and post-operative arterial serum purine concentration (uM) [ Time Frame: 24 hours ]Change in arterial serum purine concentration measured pre-, peri-, and post-operatively in CEA patients
- Pre-operative arterial serum purine concentration (uM) [ Time Frame: Baseline ]Arterial serum purine concentration measured pre-operatively in CEA patients
- Pre-operative capillary serum purine concentration (uM) [ Time Frame: Baseline ]Pre-operative capillary serum purine concentration in CEA patients and controls
- Local or general anaesthetic [ Time Frame: Baseline ]Local or general anaesthetic used during procedure in CEA patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545166
|University Hospitals of North Midlands|
|Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG|
|University Hospitals Coventry and Warwickshire|
|Coventry, West Midlands, United Kingdom, CV2 2DX|
|Study Chair:||Christopher HE Imray, MB BS PhD||University Hospitals Coventry and Warwickshire NHS Trust|
|Principal Investigator:||Jack Fairhead, BM BCh BA||University Hospitals of North Midlands NHS Trust|