Detection of Cerebral Ischemia With Artificial Intelligence- Biomarkers as Indicators in Controlled Cerebral Ischemia and Reperfusion.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Heart Rate variability
研究概览
简要总结
In patients undergoing planned surgery for carotid tromendarterendectomy, a non-invasive device that registers heart rate variability is attached. Furthermore a non-invasive device that monitors cerebral oxygenation- near infrared spectroscopy as well as electroencephalography is also attached. At times when surgeons clamps the carotid artery, there will be a moment with controlled cerebral ischemia.
This will be registered by the devices. The information obtained will be used to teach artificial intelligence what patterns are related to cerebral ischemia. The same procedure will be performed in patients undergoing ocklusive cerebral trombectomy, so the artificial intelligence will learn to recognize cerebral reperfusion.Blood samples will be drawn before and after cerebral ischemia may occur and will be analyzed for neurobiomarkers and cardiac biomarkers. To teach the algorithm patterns from anaesthesia and surgery in patients without pre existing neuronal injury, the same method will be applied to patients undergoing mixed abdominal surgery. This group will provide a better knowledge of neuro biomarker patterns during anesthesia and surgery.
详细描述
The neurobiomarkers that will be analyzed for detection of cerebral ischemia is Glial Fibrillary Acidic Protein, Neurofilament light chains, S-100B, Neuron specific endolas, Total-tau. Cardiac biomarkers are troponin-t and NT-pro brain natriuretic peptide.
Blood sampling will occur before anesthesia induction and 2 and 24 hours after surgery or plausible ischemia for patients undergoing surgery for carotid endarterectomy. For patients undergoing acute thrombectomy blood sampling will be performed as soon as possible after the patient has arrived to the hospital as well as 2 hours and 24 hours later. For patients undergoing mixed abdominal surgery, sampling will be done before anesthesia induction and 2 hours and 24 hours after surgery.
Additionally, blood from the thrombectomy cohort and the control cohort will be analyzed by an external party OLIMK, Uppsala. This is an explorative study aiming to find new biomarkers for detection of cerebral ischemia. Blood from both cohorts will be analyzed for 384 neurology biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients planned for carotid surgery or trombectomy
- •Giving informed consent to participate
排除标准
- •Patients that do not consent Patients with arrythmia or pacemaker
研究组 & 干预措施
Cerebral ischemia
Patients undergoing planned surgery for carotid stenosis
干预措施: No intervention (Other)
Reperfusion
Patients undergoing cerebral trombectomy.
干预措施: No intervention (Other)
Anaesthesia and surgery
Patients without preexisting cerebral injury undergoing abdominal surgery and anaesthesia
干预措施: No intervention (Other)
结局指标
主要结局
Heart Rate variability
时间窗: 2020-2030
Changes in Heart Rate Variability from baseline.
Biomarkers indicating cerebral ischemia in blood
时间窗: 2020-2030
Changes in levels of biomarkers in blood from baseline. Total tau, neurofilament light chains, glial fibrillary acidic protein, S-100, neuron specific endolas.
Near infrared spectroscopy
时间窗: 2020-2030
Changes in Near Infrared spectroscopy from baseline.
Electroencephalography
时间窗: 2020-2030
Changes in electroencephalography from baseline, more precisely the Power in alpha bands, beta band, delta bands and quotas between these.
Biomarkers indicating cardiac ischemia in blood
时间窗: 2020-2030
Changes in levels of biomarkers in blood from baseline. Troponin T
次要结局
未报告次要终点
研究者
Linda Block
Doctor, MD, PhD
Göteborg University