Risk Prediction Model for Cerebrovascular Events in Carotid Artery Stenosis

NCT06452173 | Enrolling By Invitation DMC

• 2 other identifiers: KY2024-070-022024-2-1072
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carotid Stenosis

Keywords

carotid stenosis; stroke; Risk prediction model; Deep-learning

Outcome Measures

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.

  Within six months from the date of consultation

Study Arms (2)

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

Plasma DIAGNOSTIC_TEST

Plasma levels of metabolites and some proteins will be further determined

high risk; low risk

carotid high-resolution magnetic resonance imaging DIAGNOSTIC_TEST

Define plaque composition and morphological characteristics

high risk; low risk

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Beijing Neurosurgical Institute: collaborator

Study Sites (1)

Beijing Tiantan hospital

Beijing, Beijing Municipality, 100070, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and plaque specimen

MeSH Terms

Conditions

Carotid Stenosis; Stroke

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yan Zhang, MD

  Beijing Neurosurgical Institution

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)