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

NCT06315153 | Active Not Recruiting DMC

• 1 other identifier: KS2023077-1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Carotid Stenosis; Ischemic Stroke

Keywords

plaque vulnerability; vascular ultrasound; atherosclerosis; ischemic stroke; contrast-enhanced ultrasound

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• ① Patients aged ≥ 40 years old; ② Complete clinical data and serological indicators; ③ Carotid artery ultrasound examination was performed after admission.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• The First Hospital of Jilin University: collaborator

Study Sites (2)

The first hospital of Jilin university

Changchun, Jilin, 130021, China

Location

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location

Related 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.

  PMID: 31781015 BACKGROUND

• 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.

  PMID: 32609972 BACKGROUND

• 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.

  PMID: 30954372 BACKGROUND

• 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.

  PMID: 36202450 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

This study does not involve specimen.

MeSH Terms

Conditions

Carotid Stenosis; Ischemic Stroke; Atherosclerosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Arteriosclerosis

Study Officials

• Yingqi Xing, PhD

  Xuanwu Hospital, Beijing

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: January 3, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2026
• Last Updated: March 18, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)