Assessing Vulnerability and Outcomes of Intracranial Atherosclerotic Plaques

Completed

• Conditions: Asymptomatic Intracranial Atherosclerotic Stenosis Patients

• Registration Number: NCT07156344
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30
• Study First Submitted: 2025-06-11
• Status Verified: 2025-08
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3849

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with Progression of Intracranial Atherosclerosis	4 years	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants with Clinical adverse event	4 years	Clinical adverse events include stroke, death, myocardial infarction, onset and progression of cognitive impairment and worsening of functional outcomes (mRS score ≥2)

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing Municipality, China