Assessing Vulnerability and Outcomes of Intracranial Atherosclerotic Plaques

NCT07156344 | Completed

• 1 other identifier: 2024-417-002
• Study Type: observational
• Target: 3,849
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective cohort study aims to establish a large-scale cohort for primary stroke prevention in asymptomatic intracranial atherosclerosis (ICAS). Objectives include: characterizing risk factor and stenotic artery distributions; determining optimal TCD screening sentinel arteries; observing plaque progression/regression via HR-MRI; establishing vulnerable plaque evaluation systems through stroke event follow-up; and developing cognitive decline prediction models integrating hemodynamic parameters. All procedures (TCD, HR-MRI, neuropsychological assessments) are routine clinical examinations with minimal risk. Participation is voluntary. Initial TCD and qualifying HR-MRI scans incur standard fees; all follow-up imaging and neuropsychological assessments post-enrollment are provided free of charge.

Conditions

Asymptomatic Intracranial Atherosclerotic Stenosis Patients

Outcome Measures

Primary Outcomes (1)

• Number of participants with Progression of Intracranial Atherosclerosis

  Number of participants with Progression of intracranial atherosclerosis encompass intracranial arterial stenosis, development of new stenoses, worsening of existing stenoses, as well as decrease, regression, or resolution of stenosis.

  4 years

Secondary Outcomes (1)

• Number of participants with Clinical adverse event

  4 years

Study Arms (1)

Asymptomatic Intracranial Atherosclerotic Patients

Diagnostic Test: Progression and Outcome of Intracranial Atherosclerosis

Interventions

Progression and Outcome of Intracranial Atherosclerosis DIAGNOSTIC_TEST

"Progression and Outcome of Intracranial Atherosclerosis" is the primary endpoint; all others are secondary endpoints. Stroke defined as any stroke and new ipsilateral stroke (including ischemic and hemorrhagic stroke) associated with vascular stenosis.

Also known as: Medically confirmed death, Myocardial infarction, Onset and Progression of Cognitive Impairment, Worsening of functional outcomes (mRS score ≥2), Stroke was identified on imaging

Asymptomatic Intracranial Atherosclerotic Patients

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Transcranial Doppler (TCD)-detected asymptomatic intracranial atherosclerotic patients

You may qualify if:

• Intracranial arterial stenosis confirmed by transcranial Doppler (TCD), clinically suspected to be of atherosclerotic origin
• No history of stroke or transient ischemic attack (TIA)
• Adequate temporal bone acoustic window penetrability

You may not qualify if:

• Clinically diagnosed non-atherosclerotic etiology-related intracranial arterial stenosis
• Poor temporal bone acoustic window penetrability
• Loss to follow-up

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• The People's Hospital of Liaoning Province: collaborator
• The First Hospital of Jilin University: collaborator
• Jilin Electric Power Hospital: collaborator
• Jilin city central hospital: collaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (3)

• Chen HX, Wang LJ, Yang Y, Yue FX, Chen LM, Xing YQ. The prevalence of intracranial stenosis in patients at low and moderate risk of stroke. Ther Adv Neurol Disord. 2019 Aug 13;12:1756286419869532. doi: 10.1177/1756286419869532. eCollection 2019.

  PMID: 31447935 BACKGROUND

• Wang YJ, Li ZX, Gu HQ, Zhai Y, Zhou Q, Jiang Y, Zhao XQ, Wang YL, Yang X, Wang CJ, Meng X, Li H, Liu LP, Jing J, Wu J, Xu AD, Dong Q, Wang D, Wang WZ, Ma XD, Zhao JZ; China Stroke Statistics Writing Committee. China Stroke Statistics: an update on the 2019 report from the National Center for Healthcare Quality Management in Neurological Diseases, China National Clinical Research Center for Neurological Diseases, the Chinese Stroke Association, National Center for Chronic and Non-communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention and Institute for Global Neuroscience and Stroke Collaborations. Stroke Vasc Neurol. 2022 Oct;7(5):415-450. doi: 10.1136/svn-2021-001374. Epub 2022 Apr 20.

  PMID: 35443985 BACKGROUND

• GBD 2021 Stroke Risk Factor Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Neurol. 2024 Oct;23(10):973-1003. doi: 10.1016/S1474-4422(24)00369-7.

  PMID: 39304265 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: September 5, 2025
• Study Start: January 1, 2019
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)