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临床试验/NCT02545166
NCT02545166已完成不适用

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

University Hospitals Coventry and Warwickshire NHS Trust2 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2016年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
198
试验地点
2
主要终点
Pre-, peri-, and post-operative arterial serum purine concentration (uM)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CEA Patients:
  • Aged 18 years and over
  • Scheduled for carotid endarterectomy
  • 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

排除标准

  • CEA patients:
  • Unable/unwilling to provide informed consent
  • 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

结局指标

主要结局

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

时间窗: 24 hours

Change in arterial serum purine concentration measured pre-, peri-, and post-operatively in CEA patients

次要结局

  • Pre-, and post-operative capillary serum purine concentration (uM)(Baseline)
  • Pre-, and post-operative arterial serum purine concentration (uM)(Baseline)
  • Local or general anaesthetic(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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