Risk Prediction Model for Cerebrovascular Events in Carotid Artery Stenosis

NCT ID: NCT06452173

Last Updated: 2024-06-13

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

ENROLLING_BY_INVITATION

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-15

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carotid Stenosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Plasma

Intervention Type DIAGNOSTIC_TEST

Plasma levels of metabolites and some proteins will be further determined

carotid high-resolution magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

Define plaque composition and morphological characteristics

low risk

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

Plasma

Intervention Type DIAGNOSTIC_TEST

Plasma levels of metabolites and some proteins will be further determined

carotid high-resolution magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

Define plaque composition and morphological characteristics

Interventions

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Plasma

Plasma levels of metabolites and some proteins will be further determined

Intervention Type DIAGNOSTIC_TEST

carotid high-resolution magnetic resonance imaging

Define plaque composition and morphological characteristics

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Neurosurgical Institute

OTHER

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Neurosurgical Institution

Locations

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Beijing Tiantan hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2024-2-1072

Identifier Type: OTHER

Identifier Source: secondary_id

KY2024-070-02

Identifier Type: -

Identifier Source: org_study_id

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