Comprehensive Assessment of Atherosclerotic Ischemic Stroke Risk and Development of a Prediction Model

Ischemic Stroke Clinical Trial

— CAIS-pre  

Official title:

Research of Comprehensive Assessment of Carotid Plaque Vulnerability and Development of Atherosclerotic Ischemic Stroke Risk Prediction Model

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06315153
• Other study ID #: KS2023077-1
• Status: Active, not recruiting
• Start date: January 3, 2022
• Est. completion date: April 1, 2026

Study information

• Verified date: May 2023
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• ? Patients aged = 40 years old; ? Complete clinical data and serological indicators; ? Carotid artery ultrasound examination was performed after admission.

Exclusion Criteria:

• ? Unilateral or bilateral carotid artery occlusion; ?Carotid stenosis caused by other reasons, such as entrapment, aortitis, radiculopathy and muscle fiber dysplasia; ?Previous carotid stenting or carotid endarterectomy; ?Carotid artery plaques are strongly echogenic with acoustic shadowing, resulting in unclear detection of the lumen.

Related Conditions & MeSH terms

• Carotid Stenosis
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing
China	The first hospital of Jilin university	Changchun	Jilin

Sponsors (2)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

Fedak 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. — View Citation

Saba 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. — View Citation

van 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years
Primary	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	2 years