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OpenTrials
Completed

NCT Number: NCT07156344

Assessing Vulnerability and Outcomes of Intracranial Atherosclerotic Plaques

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Number of participants with Progression of Intracranial Atherosclerosis

    Time frame: 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 outcomes

  1. Number of participants with Clinical adverse event

    Time frame: 4 years

    Clinical adverse events include stroke, death, myocardial infarction, onset and progression of cognitive impairment and worsening of functional outcomes (mRS score ≥2)

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • Jilin Electric Power Hospital
  • Jilin city central hospital
  • The First Hospital of Jilin University
  • The People's Hospital of Liaoning Province

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.