Study of Carotid Artery Stenosis Through the Integration of Multimodal Imaging and Computational Fluid Dynamics
- Conditions
- Carotid Stenosis
- Interventions
- Procedure: CEA/CAS
- Registration Number
- NCT06294496
- Lead Sponsor
- Sichuan Provincial People's Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Clinical diagnosis of carotid stenosis.
- Vascular stenosis with vascular malformations.
- Aneurysm.
- Severe heart, liver, or kidney disease.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CEA group CEA/CAS The patient with carotid stenosis underwent CEA surgery. CAS group CEA/CAS The patient with carotid stenosis underwent CAS treatment.
- Primary Outcome Measures
Name Time Method Perioperative cardio-cerebrovascular adverse events 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.
- Secondary Outcome Measures
Name Time Method Compute fluid dynamics parameters 1 day before the surgery, 3 days after the surgery Based on computational fluid dynamics, calculate the changes in hemodynamic parameters after CEA patients, including Shear Stress (Pa), Flow Velocity (cm/s), Wall Pressure (Pa)
Clinical outcome 6 months after surgery The clinical outcome was assessed at 6 months after treatment using the mRS score, and a good outcome was defined as a modified Rankin Scale (mRS) score of 0-2 at 6 months after surgery.
Trial Locations
- Locations (1)
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China