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临床试验/NCT06294496
NCT06294496招募中不适用

Perioperative Risk and Clinical Efficacy Study of Cervical Artery Stenosis Patients Through the Integration of Multimodal Imaging and Computational Fluid Dynamics

Sichuan Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年6月1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
40
试验地点
1
主要终点
Perioperative cardio-cerebrovascular adverse events

研究概览

简要总结

Ischemic stroke affects 2.5 to 3 million people annually in China, ranking as the leading cause of death and disability. Cervical artery stenosis is a significant contributor to this problem, with about 50% of patients experiencing cognitive impairment due to reduced cerebral blood flow. Two main surgical approaches, carotid endarterectomy (CEA) and carotid artery stenting (CAS), are used to treat severe cervical artery stenosis, but their effects on various factors remain unclear.

This project collects multimodal imaging data, including CT perfusion and angiography, to create 3D models of cervical artery stenosis. Computational fluid dynamics and AI analysis are used to assess hemodynamics. By monitoring blood flow, oxygen levels, and evaluating postoperative outcomes, the goal is to tailor surgical approaches for better patient outcomes and improved quality of life.

详细描述

In China, the annual incidence of ischemic stroke is estimated to be between 2.5 to 3 million cases, making it the leading cause of death and disability among the population. Among these cases, cervical artery stenosis is a significant independent risk factor for ischemic stroke. Approximately 50% of patients with cervical artery stenosis are prone to develop vascular-related cognitive impairment due to cerebral hypoperfusion, severely affecting human health and quality of life.

There are currently two main surgical approaches for treating severe cervical artery stenosis: carotid endarterectomy (CEA) and carotid artery stenting (CAS). The effects of these two surgical methods on preoperative and postoperative intracranial and extracranial hemodynamic changes, the mechanisms underlying perioperative complications, the establishment of collateral circulation, and long-term prognosis remain unclear. Therefore, researching perioperative risk assessment and clinical efficacy of different surgical approaches is of great significance for patient outcomes.

This project aims to collect multimodal imaging data from patients with cervical artery stenosis, including brain CT perfusion imaging and CT angiography. Using artificial intelligence algorithms, three-dimensional models of cervical artery stenosis will be reconstructed, and computational fluid dynamics will be employed to automatically or semi-automatically analyze the hemodynamic characteristics of patients' carotid arteries. By monitoring cerebral blood flow velocity, local cerebral oxygen metabolism, and assessing postoperative stroke, ischemia-reperfusion injury, and collateral circulation both intracranially and extracranially, precise evaluations will be conducted.

Based on individual patient characteristics, the surgical approach can be optimized to prevent cerebral ischemia-reperfusion injury, improve clinical prognosis, and enhance the quality of life for patients.

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

入选标准

  • Clinical diagnosis of carotid stenosis.

排除标准

  • Vascular stenosis with vascular malformations.
  • Severe heart, liver, or kidney disease.

结局指标

主要结局

Perioperative cardio-cerebrovascular adverse events

时间窗: 2 weeks after surgery

Specific adverse events related to the cardiovascular and cerebrovascular systems that may occur during the perioperative period , encompassing the time before, during, and after a CEA. These events include myocardial infarction (heart attack), cerebral hyperperfusion injury, stroke, arrhythmias (abnormal heart rhythms), and death.

次要结局

  • Compute fluid dynamics parameters(1 day before the surgery, 3 days after the surgery)
  • Clinical outcome(6 months after surgery)

研究者

发起方
Sichuan Provincial People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lei Guo

Neurologist, Department of Neurosurgery, Sichuan Provincial People's Hospital

Sichuan Provincial People's Hospital

研究点 (1)

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