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Risk Prediction Model for Cerebrovascular Events in Carotid Artery Stenosis

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Capital Medical University

Status

Invitation-only

Conditions

Carotid Stenosis

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT06452173
KY2024-070-02
2024-2-1072 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

high risk
Description:
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.
Treatment:
Diagnostic Test: Plasma
Diagnostic Test: carotid high-resolution magnetic resonance imaging
low risk
Description:
Patients without cerebrovascular events within six months are defined as low-risk carotid stenosis patients.
Treatment:
Diagnostic Test: Plasma
Diagnostic Test: carotid high-resolution magnetic resonance imaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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