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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06294496
Other study ID # 2023YFS0274
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source Sichuan Provincial People's Hospital
Contact Lei Guo, Master
Phone +86 15760551392
Email guoleii2021@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
CEA/CAS
carotid endarterectomy (CEA) and carotid artery stenting (CAS)

Locations

Country Name City State
China Sichuan Provincial People's Hospital Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

Aristova M, Vali A, Ansari SA, Shaibani A, Alden TD, Hurley MC, Jahromi BS, Potts MB, Markl M, Schnell S. Standardized Evaluation of Cerebral Arteriovenous Malformations Using Flow Distribution Network Graphs and Dual-venc 4D Flow MRI. J Magn Reson Imagin — View Citation

Fukuda S, Shimogonya Y, Yonemoto N, Fukuda M, Watanabe A, Fujiwara K, Enomoto R, Hasegawa K, Yasoda A, Tsukahara T; NHO Carotid CFD Study Group. Hemodynamic Risk Factors for the Development of Carotid Stenosis in Patients with Unilateral Carotid Stenosis. — View Citation

Gonzales NR, Demaerschalk BM, Voeks JH, Tom M, Howard G, Sheffet AJ, Garcia L, Clair DG, Barr J, Orlow S, Brott TG; CREST Investigators. Complication rates and center enrollment volume in the carotid revascularization endarterectomy versus stenting trial. — View Citation

Lanzino G, Tallarita T, Rabinstein AA. Internal carotid artery stenosis: natural history and management. Semin Neurol. 2010 Nov;30(5):518-27. doi: 10.1055/s-0030-1268864. Epub 2011 Jan 4. — View Citation

Pandian JD, Gall SL, Kate MP, Silva GS, Akinyemi RO, Ovbiagele BI, Lavados PM, Gandhi DBC, Thrift AG. Prevention of stroke: a global perspective. Lancet. 2018 Oct 6;392(10154):1269-1278. doi: 10.1016/S0140-6736(18)31269-8. — View Citation

Pavlin-Premrl D, Boopathy SR, Nemes A, Mohammadzadeh M, Monajemi S, Ko BS, Campbell BCV. Computational Fluid Dynamics in Intracranial Atherosclerosis - Lessons from Cardiology: A Review of CFD in Intracranial Atherosclerosis. J Stroke Cerebrovasc Dis. 202 — View Citation

Pessin MS, Hinton RC, Davis KR, Duncan GW, Roberson GH, Ackerman RH, Mohr JP. Mechanisms of acute carotid stroke. Ann Neurol. 1979 Sep;6(3):245-52. doi: 10.1002/ana.410060311. — View Citation

Wu S, Wu B, Liu M, Chen Z, Wang W, Anderson CS, Sandercock P, Wang Y, Huang Y, Cui L, Pu C, Jia J, Zhang T, Liu X, Zhang S, Xie P, Fan D, Ji X, Wong KL, Wang L; China Stroke Study Collaboration. Stroke in China: advances and challenges in epidemiology, prevention, and management. Lancet Neurol. 2019 Apr;18(4):394-405. doi: 10.1016/S1474-4422(18)30500-3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Perioperative cardio-cerebrovascular adverse events 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. 2 weeks after surgery
Secondary Compute fluid dynamics parameters 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) 1 day before the surgery, 3 days after the surgery
Secondary Clinical outcome 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. 6 months after surgery
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