Assessing Vulnerability and Outcomes of Intracranial Atherosclerotic Plaques

NCT ID: NCT07156344

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3849 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2025-04-30

Brief Summary

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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

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Conditions

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Asymptomatic Intracranial Atherosclerotic Stenosis Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Asymptomatic Intracranial Atherosclerotic Patients

Progression and Outcome of Intracranial Atherosclerosis

Intervention Type 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.

Interventions

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Progression 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The People's Hospital of Liaoning Province

OTHER

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

Jilin Electric Power Hospital

UNKNOWN

Sponsor Role collaborator

Jilin city central hospital

UNKNOWN

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 31447935 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35443985 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39304265 (View on PubMed)

Other Identifiers

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2024-417-002

Identifier Type: -

Identifier Source: org_study_id

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