Asymptomatic Intracranial Atherosclerotic Stenosis PatientsNCT07156344
Assessing Vulnerability and Outcomes of Intracranial Atherosclerotic Plaques
An observational study of Asymptomatic Intracranial Atherosclerotic Stenosis Patients, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Asymptomatic Intracranial Atherosclerotic Stenosis Patients
- What is being tested?
- Progression and Outcome of Intracranial Atherosclerosis
- How many people
- 3,849 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Adult, Older adult
Study population: Transcranial Doppler (TCD)-detected asymptomatic intracranial atherosclerotic patients
Who may be able to join
- 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
Who cannot join
- Clinically diagnosed non-atherosclerotic etiology-related intracranial arterial stenosis
- Poor temporal bone acoustic window penetrability
- Loss to follow-up
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: An Observational Cohort Study on the Identification and Outcome Evaluation of Intracranial Atherosclerotic Plaque Vulnerability
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.
- Being tested
- Progression and Outcome of Intracranial Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progression and Outcome of Intracranial AtherosclerosisDiagnostic test
Also called Medically confirmed death, Myocardial infarction, Onset and Progression of Cognitive Impairment, Worsening of functional outcomes (mRS score ≥2)
"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 group | Role | What they receive |
|---|---|---|
| Asymptomatic Intracranial Atherosclerotic Patients | Not described Receives: Diagnostic Test: Progression and Outcome of Intracranial Atherosclerosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (1)
Number of participants with Clinical adverse event
Clinical adverse events include stroke, death, myocardial infarction, onset and progression of cognitive impairment and worsening of functional outcomes (mRS score ≥2)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Jan 2019
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Asymptomatic Intracranial Atherosclerotic Stenosis PatientsStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,849 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- The People's Hospital of Liaoning Province, The First Hospital of Jilin University, Jilin Electric Power Hospital, Jilin city central hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156344
- Sponsor's protocol ID
- 2024-417-002
- Status last verified
- Aug 2025
- First submitted
- 11 Jun 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31447935Wang 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.
PubMed 35443985GBD 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.
PubMed 39304265
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study on the Identification and Outcome Evaluation of Intracranial Atherosclerotic Plaque Vulnerability
- ClinicalTrials.gov ID
- NCT07156344
- Acronym / sponsor ID
- 2024-417-002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,849 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- The People's Hospital of Liaoning Province, The First Hospital of Jilin University, Jilin Electric Power Hospital, Jilin city central hospital
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic Intracranial Atherosclerotic Patients | – | Diagnostic Test: Progression and Outcome of Intracranial Atherosclerosis |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Transcranial Doppler (TCD)-detected asymptomatic intracranial atherosclerotic patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Clinically diagnosed non-atherosclerotic etiology-related intracranial arterial stenosis
- Poor temporal bone acoustic window penetrability
- Loss to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progression and Outcome of Intracranial AtherosclerosisAlso: Medically confirmed death, Myocardial infarction, Onset and Progression of Cognitive Impairment, Worsening of functional outcomes (mRS score ≥2)"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. | Diagnostic test | Asymptomatic Intracranial Atherosclerotic Patients |
Primary outcome
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.
1 secondary outcome
Number of participants with Clinical adverse event
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Background: PubMed 31447935Chen 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.
- Background: PubMed 35443985Wang 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.
- Background: PubMed 39304265GBD 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.
- Individual participant dataSharing planned: No
Related trials for Asymptomatic Intracranial Atherosclerotic Stenosis Patients
Not yet recruiting
Moderate Versus Intensive Lipid-lowering for Events in Asymptomatic Intracranial Stenosis
Intracranial Atherosclerosis ICAS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asymptomatic Intracranial Atherosclerotic Stenosis Patients, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Progression of Intracranial Atherosclerosis (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07156344, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.