StrokeCEMSNCT02545166
Validation of a Purine Biosensor in Detecting Acute Cerebral Ischaemia: Carotid Endarterectomy Model in SMARTChip
An observational study of Stroke, run by University Hospitals Coventry and Warwickshire NHS Trust at 2 sites in United Kingdom.
Trial summary
This study will validate the sensitivity of a purine biosensor (SMARTChip) in detecting acute cerebral ischaemia in a group of patients undergoing elective carotid endarterectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 198 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 16 Mar 2016to 20 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 male or female patients, aged 18 years or over, scheduled for carotid endarterectomy and 80 age and sex-matched control patients scheduled for day surgery. 50 dynamic controls. 25 Local sampling patients
Who may be able to join
- CEA Patients:
- Aged 18 years and over
- Scheduled for carotid endarterectomy
- Controls
- Aged 18 years and over
- Scheduled for day surgery
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- Dynamic controls
- Aged 18 years and over
- Scheduled for open aortic aneurysm repair, critical ischaemic leg surgery (this includes: Femoral endarterectomy, Axillo-Femoral Bypass Graft, Femoral distal bypass, Fem-Fem crossover graft, Axillary bifemoral graft, Aortobifemoral graft, and Femoral popliteal bypass), endovascular aneurysm repair, Kidney transplants, or Free flap surgery.
- Local sampling
- Aged 18 and over
- Scheduled for elective lower limb vascular revascularisation, elective lower limb orthopaedic surgery with a tourniquet or diagnosed with acute compartment syndrome requiring a fasciotomy
Who cannot join
- CEA patients:
- Unable/unwilling to provide informed consent
- Controls:
- Unable/unwilling to provide informed consent
- History of cerebral ischaemia
- History of cancer
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- History of cardiovascular disease
- Unable/unwilling to provide a fasting blood sample
- Dynamic controls
- Unable/unwilling to provide informed consent
- History of cerebral ischaemia
- History of cancer (except for Free flap surgery patients)
- Local sampling
- Unable/unwilling to provide informed consent
- History of cerebral ischaemia
- History of cancer
- History of cardiovascular disease
- Unable/unwilling to provide a blood sample
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Hospitals Coventry and Warwickshire
Coventry, West Midlands, CV2 2DX
University Hospitals of North Midlands
Stoke-on-Trent, Staffordshire, ST4 6QG
About this study
This study will validate the sensitivity of a purine biosensor (SMARTChip) in detecting acute cerebral ischaemia in a group of patients undergoing elective carotid endarterectomy. The study will also investigate whether blood purine levels are indicative of future risk of stroke by comparing pre-operative blood purine levels in carotid endarterectomy patients (high risk group) and blood purine levels in a group of age and sex-matched controls.
Read the detailed description
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.
- Conditions
- Stroke
- Keywords
- Stroke, Purines, SMARTChip, Ischaemia, Carotid endarterectomy, Biosensor
- Medical subject headings
- Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| Control patients | 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. | |
| Dynamic controls | 10 aortic aneurysm repair patients, 10 critical leg ischaemia patients, 10 endovascular aneurysm repair patients, 10 kidney transplant patients, and 10 free flap surgery patients. | |
| Local sampling patients | 10 Patients undergoing revascularisation, 10 patients undergoing lower limb surgery with a tourniquet and 5 patients diagnosed with acute compartment syndrome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-, peri-, and post-operative arterial serum purine concentration (uM)
Change in arterial serum purine concentration measured pre-, peri-, and post-operatively in CEA patients
Measured: 24 hours
Secondary outcomes (3)
Pre-, and post-operative arterial serum purine concentration (uM)
Arterial serum purine concentration measured pre-operatively in CEA patients, controls and local sampling patients.
Measured: Baseline
Pre-, and post-operative capillary serum purine concentration (uM)
Pre-operative capillary serum purine concentration in CEA patients, controls and local sampling patients.
Measured: Baseline
Local or general anaesthetic
Local or general anaesthetic used during procedure in CEA patients, controls and local sampling patients.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study start16 Mar 2016
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals of North Midlands NHS Trust
- Responsible party
- Sponsor
- Investigators
- Christopher HE Imray, MB BS PhD, Study chair, University Hospitals Coventry and Warwickshire NHS TrustJack Fairhead, BM BCh BA, Principal investigator, University Hospitals of North Midlands NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545166
- Sponsor's protocol ID
- CI163115
- Acronym
- CEMS
- Status last verified
- Jul 2022
- First submitted
- 7 Sep 2015
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Purine Biosensor in Detecting Acute Cerebral Ischaemia: Carotid Endarterectomy Model in SMARTChip
- ClinicalTrials.gov ID
- NCT02545166
- Acronym / sponsor ID
- CEMS / CI163115
- Conditions
- Stroke
- Keywords
- Stroke, Purines, SMARTChip, Ischaemia, Carotid endarterectomy, Biosensor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Collaborators
- University Hospitals of North Midlands NHS Trust
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will validate the sensitivity of a purine biosensor (SMARTChip) in detecting acute cerebral ischaemia in a group of patients undergoing elective carotid endarterectomy. The study will also investigate whether blood purine levels are indicative of future risk of stroke by comparing pre-operative blood purine levels in carotid endarterectomy patients (high risk group) and blood purine levels in a group of age and sex-matched controls.
Detailed description
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Control patients | – | –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. |
| Dynamic controls | – | –10 aortic aneurysm repair patients, 10 critical leg ischaemia patients, 10 endovascular aneurysm repair patients, 10 kidney transplant patients, and 10 free flap surgery patients. |
| Local sampling patients | – | –10 Patients undergoing revascularisation, 10 patients undergoing lower limb surgery with a tourniquet and 5 patients diagnosed with acute compartment syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 male or female patients, aged 18 years or over, scheduled for carotid endarterectomy and 80 age and sex-matched control patients scheduled for day surgery. 50 dynamic controls. 25 Local sampling patients
Key inclusion criteria (12 listed)
- Aged 18 years and over
- Scheduled for carotid endarterectomy
- Controls
- Aged 18 years and over
- Scheduled for day surgery
Key exclusion criteria (18 listed)
- Unable/unwilling to provide informed consent
- Unable/unwilling to provide informed consent
- History of cerebral ischaemia
- History of cancer
- History of cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Pre-, and post-operative arterial serum purine concentration (uM)
Time frame: Baseline
Pre-, and post-operative capillary serum purine concentration (uM)
Time frame: Baseline
Local or general anaesthetic
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher HE Imray, MB BS PhD study chair
University Hospitals Coventry and Warwickshire NHS Trust
Jack Fairhead, BM BCh BA principal investigator
University Hospitals of North Midlands NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University Hospitals Coventry and Warwickshire NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-, peri-, and post-operative arterial serum purine concentration (uM) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.