Assessing Vulnerability and Outcomes of Intracranial Atherosclerotic Plaques

An Observational Cohort Study on the Identification and Outcome Evaluation of Intracranial Atherosclerotic Plaque Vulnerability

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07156344

Enrollment

3849

Registered

2025-09-05

Start date

2019-01-01

Completion date

2025-04-30

Last updated

2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic Intracranial Atherosclerotic Stenosis Patients

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.

Interventions

DIAGNOSTIC_TESTProgression and Outcome of Intracranial Atherosclerosis

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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026