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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 : Recruiting
First Posted : September 9, 2015
Last Update Posted : October 18, 2018
Sponsor:
Collaborator:
University Hospitals of North Midlands NHS Trust
Information provided by (Responsible Party):
University Hospitals Coventry and Warwickshire NHS Trust

Brief 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. 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.

Condition or disease
Stroke

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 Type : Observational
Estimated Enrollment : 195 participants
Observational Model: Case-Control
Time Perspective: Prospective
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 2019
Estimated Study Completion Date : June 2019

Group/Cohort
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Pre-, and post-operative arterial serum purine concentration (uM) [ Time Frame: Baseline ]
    Arterial serum purine concentration measured pre-operatively in CEA patients, controls and local sampling patients.

  2. Pre-, and post-operative capillary serum purine concentration (uM) [ Time Frame: Baseline ]
    Pre-operative capillary serum purine concentration in CEA patients, controls and local sampling patients.

  3. Local or general anaesthetic [ Time Frame: Baseline ]
    Local or general anaesthetic used during procedure in CEA patients, controls and local sampling patients.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

CEA Patients:

  • Aged 18 years and over
  • Scheduled for carotid endarterectomy

Controls

  • Aged 18 years and over
  • Scheduled for day surgery

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

Exclusion Criteria:

CEA patients:

- Unable/unwilling to provide informed consent

Controls:

  • Unable/unwilling to provide informed consent
  • History of cerebral ischaemia
  • History of cancer
  • 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

Information from the National Library of Medicine

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


Contacts
Contact: Christopher HE Imray, MB BS PhD 00442476965222 ext 25222 christopher.imray@uhcw.nhs.uk
Contact: Katie M Bruce, MSc 02476966907 ext 26907 katie.bruce@uhcw.nhs.uk

Locations
United Kingdom
University Hospitals of North Midlands Not yet recruiting
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Contact: Jack Fairhead, BM BCh BA    00441782 679884    jfairhead@doctors.org.uk   
University Hospitals Coventry and Warwickshire Recruiting
Coventry, West Midlands, United Kingdom, CV2 2DX
Contact: Christopher HE Imray, MB BS PhD    02476965222 ext 65222    christopher.imray@uhcw.nhs.uk   
Contact: Katie M Bruce, MSc    00442476966907 ext 26907    katie.bruce@uhcw.nhs.uk   
Principal Investigator: Christopher HE Imray, MB BS PhD         
Sponsors and Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
University Hospitals of North Midlands NHS Trust
Investigators
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

Responsible Party: University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier: NCT02545166     History of Changes
Other Study ID Numbers: CI163115
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

Keywords provided by University Hospitals Coventry and Warwickshire NHS Trust:
Stroke
Purines
SMARTChip
Ischaemia
Carotid endarterectomy
Biosensor

Additional relevant MeSH terms:
Ischemia
Brain Ischemia
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Stroke