Carotid StenosisNCT06294496
Study of Carotid Artery Stenosis Through the Integration of Multimodal Imaging and Computational Fluid Dynamics
An observational study of Carotid Stenosis, run by Sichuan Provincial People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- CEA/CAS
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 31 Dec 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged between 18 and 80 years old
Who may be able to join
- 1) Clinical diagnosis of carotid stenosis.
Who cannot join
- Vascular stenosis with vascular malformations.
- Aneurysm.
- Severe heart, liver, or kidney disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Li Xiong, Master, 028-87393020, lcl1206778081@163.com
Chaoqun Zeng, Ph.D.
About this study
Official title: Perioperative Risk and Clinical Efficacy Study of Cervical Artery Stenosis Patients Through the Integration of Multimodal Imaging and Computational Fluid Dynamics
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.
Read the 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.
- Conditions
- Carotid Stenosis
- Being tested
- CEA/CAS
- Keywords
- Carotid Stenosis, Multimodal Imaging, Computational Fluid Dynamics
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEA/CASProcedure or surgery
carotid endarterectomy (CEA) and carotid artery stenting (CAS)
| Study group | Role | What they receive |
|---|---|---|
| CEA group | The patient with carotid stenosis underwent CEA surgery. Receives: Procedure: CEA/CAS | |
| CAS group | The patient with carotid stenosis underwent CAS treatment. Receives: Procedure: CEA/CAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks after surgery
Secondary outcomes (2)
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)
Measured: 1 day before the surgery, 3 days after the surgery
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.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Jun 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Guo, Sichuan Provincial People's Hospital
- Investigators
- Chunling Li, MD, Principal investigator, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294496
- Sponsor's protocol ID
- 2023YFS0274
- Status last verified
- Mar 2024
- First submitted
- 16 Sep 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the research is completed, it is possible to share the research plan and research report with other researchers.
Publications
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.
PubMed 534423Wu 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.
PubMed 30878104Pandian 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.
PubMed 30319114Lanzino 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.
PubMed 21207344Aristova 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 Imaging. 2019 Dec;50(6):1718-1730. doi: 10.1002/jmri.26784. Epub 2019 May 9.
PubMed 31070849Gonzales 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. Stroke. 2014 Nov;45(11):3320-4. doi: 10.1161/STROKEAHA.114.006228. Epub 2014 Sep 25.
PubMed 25256180Fukuda 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. World Neurosurg. 2022 Apr;160:e353-e371. doi: 10.1016/j.wneu.2022.01.019. Epub 2022 Jan 11.
PubMed 35026460Pavlin-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. 2021 Oct;30(10):106009. doi: 10.1016/j.jstrokecerebrovasdis.2021.106009. Epub 2021 Jul 31.
PubMed 34343837
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Risk and Clinical Efficacy Study of Cervical Artery Stenosis Patients Through the Integration of Multimodal Imaging and Computational Fluid Dynamics
- ClinicalTrials.gov ID
- NCT06294496
- Acronym / sponsor ID
- 2023YFS0274
- Conditions
- Carotid Stenosis
- Keywords
- Carotid Stenosis, Multimodal Imaging, Computational Fluid Dynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEA group | – | Procedure: CEA/CASThe patient with carotid stenosis underwent CEA surgery. |
| CAS group | – | Procedure: CEA/CASThe patient with carotid stenosis underwent CAS treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged between 18 and 80 years old
Key inclusion criteria (1 listed)
- 1) Clinical diagnosis of carotid stenosis.
Key exclusion criteria (3 listed)
- Vascular stenosis with vascular malformations.
- Aneurysm.
- Severe heart, liver, or kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEA/CAScarotid endarterectomy (CEA) and carotid artery stenting (CAS) | Procedure or surgery | CAS group, CEA group |
Primary outcome
Perioperative cardio-cerebrovascular adverse events
Time frame: 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.
2 secondary outcomes
Compute fluid dynamics parameters
Time frame: 1 day before the surgery, 3 days after the surgery
Clinical outcome
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 534423Pessin 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.
- Background: PubMed 30878104Wu 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.
- Background: PubMed 30319114Pandian 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.
- Results publication: PubMed 21207344Lanzino 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.
- Results publication: PubMed 31070849Aristova 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 Imaging. 2019 Dec;50(6):1718-1730. doi: 10.1002/jmri.26784. Epub 2019 May 9.
- Results publication: PubMed 25256180Gonzales 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. Stroke. 2014 Nov;45(11):3320-4. doi: 10.1161/STROKEAHA.114.006228. Epub 2014 Sep 25.
- Results publication: PubMed 35026460Fukuda 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. World Neurosurg. 2022 Apr;160:e353-e371. doi: 10.1016/j.wneu.2022.01.019. Epub 2022 Jan 11.
- Results publication: PubMed 34343837Pavlin-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. 2021 Oct;30(10):106009. doi: 10.1016/j.jstrokecerebrovasdis.2021.106009. Epub 2021 Jul 31.
- Individual participant dataSharing planned: Yes. After the research is completed, it is possible to share the research plan and research report with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunling Li, MD principal investigator
Sichuan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Stenosis, run by Sichuan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Guo, Master (+86 15760551392, guoleii2021@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative cardio-cerebrovascular adverse events (time frame: 2 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06294496, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.