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Study of Carotid Artery Stenosis Through the Integration of Multimodal Imaging and Computational Fluid Dynamics

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06294496
Enrollment
40
Registered
2024-03-05
Start date
2023-06-01
Completion date
2024-12-31
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Stenosis

Keywords

Carotid Stenosis, Multimodal Imaging, Computational Fluid Dynamics

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.

Interventions

PROCEDURECEA/CAS

carotid endarterectomy (CEA) and carotid artery stenting (CAS)

Sponsors

Sichuan Provincial People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1\) Clinical diagnosis of carotid stenosis.

Exclusion criteria

1. Vascular stenosis with vascular malformations. 2. Aneurysm. 3. Severe heart, liver, or kidney disease.

Design outcomes

Primary

MeasureTime frameDescription
Perioperative cardio-cerebrovascular adverse events2 weeks after surgerySpecific 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

MeasureTime frameDescription
Compute fluid dynamics parameters1 day before the surgery, 3 days after the surgeryBased 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 outcome6 months after surgeryThe 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.

Countries

China

Contacts

Primary ContactLei Guo, Master
guoleii2021@hotmail.com+86 15760551392
Backup ContactLi Xiong, Master
lcl1206778081@163.com028-87393332

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026