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Enrolling by invitationNCT06452173Updated Jun 13, 2024

Risk Prediction Model for Cerebrovascular Events in Carotid Artery Stenosis

An observational study in Carotid Stenosis, sponsored by Beijing Tiantan Hospital. Enrolling by invitation at 1 site in China. Per ClinicalTrials.gov, last updated 2024-06-13.

Sponsored by Beijing Tiantan Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
300
Sex
All
01

Study summary

Atherosclerotic carotid artery stenosis is a major cause of stroke, and early identification of high-risk patients combined with surgical intervention can significantly reduce stroke risk. Currently, stroke risk assessment in patients with carotid artery stenosis primarily relies on imaging indicators such as plaque morphology, composition, and degree of stenosis, with less emphasis on indicators directly related to inflammation, hemodynamics, and plaque instability. Certain circulating metabolites are closely linked to plaque progression and are direct risk factors for stroke. However, there is a lack of stroke risk prediction models for patients with carotid stenosis that incorporate these indicators, and the ability to identify high-risk patients needs improvement.

This study proposes using deep learning technology to integrate multidimensional data from plaque imaging, fluid dynamics, circulating metabolomics, and proteomics to construct an accurate prediction model for cerebrovascular events in patients with carotid artery stenosis. Additionally, it aims to explore markers of plaque instability characteristics based on plaque pathology. The study is expected to provide a basis for identifying high-risk patients with carotid artery stenosis, thereby laying the foundation for reducing stroke risk and improving long-term patient outcomes.

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Conditions studied

  • Carotid Stenosis

Keywords

  • carotid stenosis
  • stroke
  • Risk prediction model
  • Deep-learning
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In context

Carotid Stenosis

339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.

This study's planned enrollment of 300 is above the median of 173 across 144 observational studies indexed under Carotid Stenosis.

Browse Carotid Stenosis studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients who met the enrollment criteria at Beijing Tiantan Hospital.

Inclusion criteria

  • Patients diagnosed with atherosclerotic carotid stenosis;
  • Those who signed informed consent and volunteered to participate in this study.

Exclusion criteria

Exclusion Criteria:

  • Patients with combined severe stenosis of intracranial arteries;
  • Patients with combined cardiogenic embolism, vasculitis, entrapment aneurysm and other related cerebral infarction;
  • Combination of tumors, rheumatic immune system diseases, hematologic diseases and other diseases that change blood metabolism and proteomic characteristics;
  • There are contraindications to magnetic resonance scanning and allergy to gadolinium contrast agent;
  • Inability to cooperate in completing the relevant examinations.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Target follow-up
1 Week
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • high risk

    Patients with cerebrovascular events within six months, including i. cerebral infarction in the middle cerebral artery territory on the side of carotid stenosis; ii. transient ischemic attack symptoms (including motor and sensory) in the hemisphere on the side of stenosis; and iii. transient amaurosis on the side of stenosis. This indicates an unstable condition and such patients are defined as high-risk carotid stenosis patients.

    Diagnostic Test: Plasma · Diagnostic Test: carotid high-resolution magnetic resonance imaging

  • low risk

    Patients without cerebrovascular events within six months are defined as low-risk carotid stenosis patients.

    Diagnostic Test: Plasma · Diagnostic Test: carotid high-resolution magnetic resonance imaging

Interventions

  • Diagnostic testPlasma

    Plasma levels of metabolites and some proteins will be further determined

  • Diagnostic testcarotid high-resolution magnetic resonance imaging

    Define plaque composition and morphological characteristics

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What researchers measure

Primary outcomes

  1. Number of Patients with Cerebrovascular Events

    Patients will be categorized as having a cerebrovascular event if they meet one of the following indicators: i. cerebral infarction in the middle cerebral artery territory on the side of carotid stenosis; ii. transient ischemic attack symptoms (including motor and sensory) in the hemisphere on the side of stenosis; and iii. transient amaurosis on the side of stenosis.

    Time frame: Within six months from the date of consultation

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Study locations

1 site
  • Beijing Tiantan hospital
    Beijing, Beijing 100070, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06452173
Lead sponsor
Beijing Tiantan Hospital
Collaborators
Beijing Neurosurgical Institute
Responsible party
Sponsor
First posted
Jun 11, 2024
Start date
Apr 15, 2024
Primary completion
Oct 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 13, 2024

Study contacts

Yan Zhang, MD
principal investigator · Beijing Neurosurgical Institution

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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