Validation of a Purine Biosensor in Detecting Acute Cerebral Ischaemia: Carotid Endarterectomy Model in SMARTChip

NCT02545166 | Completed

• 1 other identifier: CI163115
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

Stroke; Purines; SMARTChip; Ischaemia; Carotid endarterectomy; Biosensor

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Secondary Outcomes (3)

• Pre-, and post-operative arterial serum purine concentration (uM)

  Baseline

• Pre-, and post-operative capillary serum purine concentration (uM)

  Baseline

• Local or general anaesthetic

  Baseline

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead
• University Hospitals of North Midlands NHS Trust: collaborator

Study Sites (2)

University Hospitals of North Midlands

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

University Hospitals Coventry and Warwickshire

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher HE Imray, MB BS PhD

  University Hospitals Coventry and Warwickshire NHS Trust

  STUDY CHAIR

• Jack Fairhead, BM BCh BA

  University Hospitals of North Midlands NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: September 9, 2015
• Study Start: March 16, 2016
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Locations

GB (2)