Carotid StenosisCAIS-preNCT06315153
Comprehensive Assessment of Atherosclerotic Ischemic Stroke Risk and Development of a Prediction Model
An observational study of Carotid Stenosis and Ischemic Stroke, run by Xuanwu Hospital, Beijing at 2 sites in China.
Trial summary
This observational study was designed for the assessment of plaque vulnerability in patients with carotid atherosclerotic stenosis and the development of predictive models for the occurrence and recurrence of atherosclerotic ischemic stroke. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Carotid Stenosis, Ischemic Stroke
- How many people
- 500 participants
- Where
- 2 sitesChina
- Study dates
- 3 Jan 2022to 1 Apr 2026
- How long will I take part?
- 2 Years
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Five hundred hospitalized patients with ≥50% carotid artery stenosis between January 2022 and January 2024 were collected, including 400 in Xuanwu Hospital of Capital Medical University and 100 in the First Hospital of Jilin University.
Who may be able to join
- ① Patients aged ≥ 40 years old; ② Complete clinical data and serological indicators; ③ Carotid artery ultrasound examination was performed after admission.
Who cannot join
- ① Unilateral or bilateral carotid artery occlusion; ②Carotid stenosis caused by other reasons, such as entrapment, aortitis, radiculopathy and muscle fiber dysplasia; ③Previous carotid stenting or carotid endarterectomy; ④Carotid artery plaques are strongly echogenic with acoustic shadowing, resulting in unclear detection of the lumen.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Xuanwu Hospital, Capital Medical University
Beijing, 100053
The first hospital of Jilin university
Changchun, Jilin, 130021
About this study
Official title: Research of Comprehensive Assessment of Carotid Plaque Vulnerability and Development of Atherosclerotic Ischemic Stroke Risk Prediction Model
This observational study was designed for the assessment of plaque vulnerability in patients with carotid atherosclerotic stenosis and the development of predictive models for the occurrence and recurrence of atherosclerotic ischemic stroke.
The objectives of the study were as follows: first, to integrate the degree of carotid stenosis and plaque characteristics assessed by vascular ultrasound for a comprehensive assessment of plaque vulnerability; second, to develop an assessment tool for the risk of future ischemic stroke in patients with asymptomatic carotid stenosis by combining vascular risk factors, serologic markers, carotid ultrasound characteristics, and contrast-enhanced ultrasonographic parameters; and third, to incorporate vascular ultrasound parameters into existing predictive models of ischemic stroke recurrence risk to develop a risk assessment tool for atherosclerotic ischemic stroke.
Read more
The main questions it aims to answer are:
- How to screen high-risk patients and those eligible for revascularization from asymptomatic carotid stenosis patients for primary prevention of stroke.
- How to improve the prediction accuracy of atherosclerotic ischemic stroke based on existing prediction models for secondary prevention of stroke.
Read the detailed description
The data from January 2022 to December 2022 was obtained from the electronic medical record system, but there will be a two-year follow-up of the data. Therefore, this is a two-way cohort study, containing both a retrospective and prospective cohort.
- Conditions
- Carotid Stenosis, Ischemic Stroke
- Keywords
- plaque vulnerability, vascular ultrasound, atherosclerosis, ischemic stroke, contrast-enhanced ultrasound
- Medical subject headings
- Carotid Stenosis, Ischemic Stroke, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| symptomatic group | An ischemic stroke was defined as occurring if the patient developed clinical symptoms related to neurological deficits and/or new infarcted lesions were detected on magnetic resonance imaging, and patients who developed ischemic strokes were classified in the symptomatic group. | |
| asymptomatic group | Patients without an ischemic stroke were classified in the asymptomatic group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of ischemic stroke
Clinical symptoms related to neurological deficits in patients and/or discovery of new infarcted lesions on head magnetic resonance imaging/computed tomography scans
Measured: 2 years
The recurrence of ischemic stroke
Clinical symptoms related to neurological deficits in patients and/or discovery of new infarcted lesions on head magnetic resonance imaging/computed tomography scans
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start3 Jan 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Jilin University
- Responsible party
- Sponsor
- Investigators
- Yingqi Xing, PhD, Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315153
- Sponsor's protocol ID
- KS2023077-1
- Acronym
- CAIS-pre
- Status last verified
- May 2023
- First submitted
- 11 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chaudhary D, Abedi V, Li J, Schirmer CM, Griessenauer CJ, Zand R. Clinical Risk Score for Predicting Recurrence Following a Cerebral Ischemic Event. Front Neurol. 2019 Nov 12;10:1106. doi: 10.3389/fneur.2019.01106. eCollection 2019.
PubMed 31781015Fedak A, Ciuk K, Urbanik A. Ultrasonography of vulnerable atherosclerotic plaque in the carotid arteries: B-mode imaging. J Ultrason. 2020;20(81):e135-e145. doi: 10.15557/JoU.2020.0022. Epub 2020 Jun 15.
PubMed 32609972Saba L, Saam T, Jager HR, Yuan C, Hatsukami TS, Saloner D, Wasserman BA, Bonati LH, Wintermark M. Imaging biomarkers of vulnerable carotid plaques for stroke risk prediction and their potential clinical implications. Lancet Neurol. 2019 Jun;18(6):559-572. doi: 10.1016/S1474-4422(19)30035-3. Epub 2019 Apr 4.
PubMed 30954372van Dam-Nolen DHK, Truijman MTB, van der Kolk AG, Liem MI, Schreuder FHBM, Boersma E, Daemen MJAP, Mess WH, van Oostenbrugge RJ, van der Steen AFW, Bos D, Koudstaal PJ, Nederkoorn PJ, Hendrikse J, van der Lugt A, Kooi ME; PARISK Study Group. Carotid Plaque Characteristics Predict Recurrent Ischemic Stroke and TIA: The PARISK (Plaque At RISK) Study. JACC Cardiovasc Imaging. 2022 Oct;15(10):1715-1726. doi: 10.1016/j.jcmg.2022.04.003. Epub 2022 Jun 15.
PubMed 36202450Cui L, Zhou F, Chen Y, Liu R, Xing Y. The lipid ratio castelli's risk index II is a novel biomarker for intraplaque neovascularization in patients with carotid stenosis. Lipids Health Dis. 2025 Dec 6;25(1):11. doi: 10.1186/s12944-025-02821-1.
PubMed 41353547
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Comprehensive Assessment of Carotid Plaque Vulnerability and Development of Atherosclerotic Ischemic Stroke Risk Prediction Model
- ClinicalTrials.gov ID
- NCT06315153
- Acronym / sponsor ID
- CAIS-pre / KS2023077-1
- Conditions
- Carotid Stenosis, Ischemic Stroke
- Keywords
- plaque vulnerability, vascular ultrasound, atherosclerosis, ischemic stroke, contrast-enhanced ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- The First Hospital of Jilin University
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 18 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.
This observational study was designed for the assessment of plaque vulnerability in patients with carotid atherosclerotic stenosis and the development of predictive models for the occurrence and recurrence of atherosclerotic ischemic stroke.
The objectives of the study were as follows: first, to integrate the degree of carotid stenosis and plaque characteristics assessed by vascular ultrasound for a comprehensive assessment of plaque vulnerability; second, to develop an assessment tool for the risk of future ischemic stroke in patients with asymptomatic carotid stenosis by combining vascular risk factors, serologic markers, carotid ultrasound characteristics, and contrast-enhanced ultrasonographic parameters; and third, to incorporate vascular ultrasound parameters into existing predictive models of ischemic stroke recurrence risk to develop a risk assessment tool for atherosclerotic ischemic stroke.
The main questions it aims to answer are:
- How to screen high-risk patients and those eligible for revascularization from asymptomatic carotid stenosis patients for primary prevention of stroke.
- How to improve the prediction accuracy of atherosclerotic ischemic stroke based on existing prediction models for secondary prevention of stroke.
Detailed description
The data from January 2022 to December 2022 was obtained from the electronic medical record system, but there will be a two-year follow-up of the data. Therefore, this is a two-way cohort study, containing both a retrospective and prospective cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| symptomatic group | – | –An ischemic stroke was defined as occurring if the patient developed clinical symptoms related to neurological deficits and/or new infarcted lesions were detected on magnetic resonance imaging, and patients who developed ischemic strokes were classified in the symptomatic group. |
| asymptomatic group | – | –Patients without an ischemic stroke were classified in the asymptomatic group. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Five hundred hospitalized patients with ≥50% carotid artery stenosis between January 2022 and January 2024 were collected, including 400 in Xuanwu Hospital of Capital Medical University and 100 in the First Hospital of Jilin University.
Key inclusion criteria (1 listed)
- ① Patients aged ≥ 40 years old; ② Complete clinical data and serological indicators; ③ Carotid artery ultrasound examination was performed after admission.
Key exclusion criteria (1 listed)
- ① Unilateral or bilateral carotid artery occlusion; ②Carotid stenosis caused by other reasons, such as entrapment, aortitis, radiculopathy and muscle fiber dysplasia; ③Previous carotid stenting or carotid endarterectomy; ④Carotid artery plaques are strongly echogenic with acoustic shadowing, resulting in unclear detection of the lumen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The occurrence of ischemic stroke
Time frame: 2 years
Clinical symptoms related to neurological deficits in patients and/or discovery of new infarcted lesions on head magnetic resonance imaging/computed tomography scans
The recurrence of ischemic stroke
Time frame: 2 years
Clinical symptoms related to neurological deficits in patients and/or discovery of new infarcted lesions on head magnetic resonance imaging/computed tomography scans
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Background: PubMed 31781015Chaudhary D, Abedi V, Li J, Schirmer CM, Griessenauer CJ, Zand R. Clinical Risk Score for Predicting Recurrence Following a Cerebral Ischemic Event. Front Neurol. 2019 Nov 12;10:1106. doi: 10.3389/fneur.2019.01106. eCollection 2019.
- Background: PubMed 32609972Fedak A, Ciuk K, Urbanik A. Ultrasonography of vulnerable atherosclerotic plaque in the carotid arteries: B-mode imaging. J Ultrason. 2020;20(81):e135-e145. doi: 10.15557/JoU.2020.0022. Epub 2020 Jun 15.
- Background: PubMed 30954372Saba L, Saam T, Jager HR, Yuan C, Hatsukami TS, Saloner D, Wasserman BA, Bonati LH, Wintermark M. Imaging biomarkers of vulnerable carotid plaques for stroke risk prediction and their potential clinical implications. Lancet Neurol. 2019 Jun;18(6):559-572. doi: 10.1016/S1474-4422(19)30035-3. Epub 2019 Apr 4.
- Background: PubMed 36202450van Dam-Nolen DHK, Truijman MTB, van der Kolk AG, Liem MI, Schreuder FHBM, Boersma E, Daemen MJAP, Mess WH, van Oostenbrugge RJ, van der Steen AFW, Bos D, Koudstaal PJ, Nederkoorn PJ, Hendrikse J, van der Lugt A, Kooi ME; PARISK Study Group. Carotid Plaque Characteristics Predict Recurrent Ischemic Stroke and TIA: The PARISK (Plaque At RISK) Study. JACC Cardiovasc Imaging. 2022 Oct;15(10):1715-1726. doi: 10.1016/j.jcmg.2022.04.003. Epub 2022 Jun 15.
- Derived from this study: PubMed 41353547Cui L, Zhou F, Chen Y, Liu R, Xing Y. The lipid ratio castelli's risk index II is a novel biomarker for intraplaque neovascularization in patients with carotid stenosis. Lipids Health Dis. 2025 Dec 6;25(1):11. doi: 10.1186/s12944-025-02821-1.
- Individual participant dataSharing planned: No
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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.
Yingqi Xing, PhD study chair
Xuanwu Hospital, Beijing
2 sites 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 and Ischemic Stroke, run by Xuanwu Hospital, Beijing at 2 sites 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 1 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 18 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 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of ischemic stroke (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT06315153, which also lists 5 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 18 Mar 2024.