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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06315153
Other study ID # KS2023077-1
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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