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临床试验/NCT05800821
NCT05800821招募中不适用

Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning

State Institution "Republican Scientific and Practical Center" Cardiology, Belarus1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Number of Participants with Cerebral Hyperperfusion Syndrome

研究概览

简要总结

Cerebral hyperperfusion syndrome (CHS) was initially described as a clinical complication following carotid endarterectomy (CEA), but it may occur after both CEA and carotid artery stenting. It is characterised by throbbing ipsilateral frontotemporal or periorbital headache, and sometimes diffuse headache, eye and facial pain, vomiting, confusion, macular oedema, visual disturbances, focal motor seizures with frequent secondary generalisation, focal neurological deficits, and intracerebral or subarachnoid haemorrhage.

Knowledge of CHS among physicians remains limited. Most studies report an incidence of 1-3% after carotid endarterectomy. CHS is most common in patients with increases of more than 100% in cerebral perfusion compared with baseline after carotid revascularization, and is rare in patients with perfusion increases of less than 100% compared with baseline.

The pathophysiological mechanism of CHS is only partially understood. The chronic low-flow state induced by severe carotid disease results in compensatory dilation of cerebral vessels distal to the stenosis, as part of the normal autoregulatory response to maintain adequate cerebral blood flow (CBF). In this chronically dilated state, the vessels lose their ability to autoregulate vascular resistance in response to changes in blood pressure. Dysautoregulation has been shown to be proportional to the duration and severity of chronic hypoperfusion. After revascularization and reperfusion, impaired cerebral autoregulation may contribute to a cascade of intracranial microcirculatory changes, with an inability to respond adequately to the augmentation of CBF following carotid recanalization.

Although most patients present with mild symptoms and signs, progression to severe and life-threatening complications can occur if CHS is not recognised and treated promptly. Because CHS is diagnosed on the basis of several non-specific signs and symptoms, patients may be misdiagnosed as having one of the better-known causes of perioperative complications, such as thromboembolism.

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
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 30 and 80 years.
  • Occlusive-stenotic lesion of the carotid arteries with indications for carotid revascularization.

排除标准

  • Systemic vasculitis.
  • Cerebral vessel aneurysms.
  • Arteriovenous malformation of the brain.
  • Primary brain tumor (including metastatic lesions).
  • History of traumatic brain injury.
  • Demyelinating diseases of the central nervous system.
  • History of neuroinfection.
  • Atrial fibrillation.
  • Frequent supraventricular or ventricular extrasystoles.
  • Chronic heart failure with left ventricular ejection fraction less than 40%.
  • Chronic kidney disease with estimated glomerular filtration rate less than 45 mL/min/1.73 m².
  • Presence of an implanted cardioverter-defibrillator or pacemaker.
  • Presence of contraindications to the medical use of iodine-containing radiographic contrast agents.
  • Patient's unwillingness to continue participating in the study.
  • Absence of a temporal acoustic window for transcranial Doppler ultrasonography.

结局指标

主要结局

Number of Participants with Cerebral Hyperperfusion Syndrome

时间窗: Occurrence of symptoms within 30 postoperative days

The diagnosis of cerebral hyperperfusion syndrome will be based on the following criteria: 1. Appearance of symptoms within 1 month after surgery. 2. First-time unilateral headache, convulsions, hemiparesis/hemiplegia, visual disturbances, ataxia, Glasgow Coma Scale score \< 15 points, aphasia, or signs of cerebral edema or intracerebral hemorrhage. 3. Symptoms of "luxury perfusion syndrome" occurring within the first 24-48 hours after restoration of blood flow through the internal carotid artery. 4. Increase in cerebral blood flow in the middle cerebral artery \> 100% compared with the preoperative value, measured by transcranial Doppler ultrasonography. 5. Exclusion of differential diagnoses, including hypertensive encephalopathy, reversible posterior leukoencephalopathy syndrome, and reversible cerebral vasoconstriction syndrome. 6. Neurological symptoms occurring in the context of high blood pressure.

次要结局

未报告次要终点

研究者

发起方
State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Ivan Maiseyenka

Principal Investigator, Vascular Surgery Research Laboratory

State Institution "Republican Scientific and Practical Center" Cardiology, Belarus

研究点 (1)

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