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Clinical Trials/NCT06315153
NCT06315153
Active, not recruiting
Not Applicable

Research of Comprehensive Assessment of Carotid Plaque Vulnerability and Development of Atherosclerotic Ischemic Stroke Risk Prediction Model

Xuanwu Hospital, Beijing2 sites in 1 country500 target enrollmentJanuary 3, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carotid Stenosis
Sponsor
Xuanwu Hospital, Beijing
Enrollment
500
Locations
2
Primary Endpoint
The occurrence of ischemic stroke
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

This observational study was designed for the assessment of plaque vulnerability in patients with carotid atherosclerotic stenosis and the development of predictive models for the occurrence and recurrence of atherosclerotic ischemic stroke.

The objectives of the study were as follows: first, to integrate the degree of carotid stenosis and plaque characteristics assessed by vascular ultrasound for a comprehensive assessment of plaque vulnerability; second, to develop an assessment tool for the risk of future ischemic stroke in patients with asymptomatic carotid stenosis by combining vascular risk factors, serologic markers, carotid ultrasound characteristics, and contrast-enhanced ultrasonographic parameters; and third, to incorporate vascular ultrasound parameters into existing predictive models of ischemic stroke recurrence risk to develop a risk assessment tool for atherosclerotic ischemic stroke.

The main questions it aims to answer are:

  • How to screen high-risk patients and those eligible for revascularization from asymptomatic carotid stenosis patients for primary prevention of stroke.
  • How to improve the prediction accuracy of atherosclerotic ischemic stroke based on existing prediction models for secondary prevention of stroke.

Detailed Description

The data from January 2022 to December 2022 was obtained from the electronic medical record system, but there will be a two-year follow-up of the data. Therefore, this is a two-way cohort study, containing both a retrospective and prospective cohort.

Registry
clinicaltrials.gov
Start Date
January 3, 2022
End Date
April 1, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ① Patients aged ≥ 40 years old; ② Complete clinical data and serological indicators; ③ Carotid artery ultrasound examination was performed after admission.

Exclusion Criteria

  • ① Unilateral or bilateral carotid artery occlusion; ②Carotid stenosis caused by other reasons, such as entrapment, aortitis, radiculopathy and muscle fiber dysplasia; ③Previous carotid stenting or carotid endarterectomy; ④Carotid artery plaques are strongly echogenic with acoustic shadowing, resulting in unclear detection of the lumen.

Outcomes

Primary Outcomes

The occurrence of ischemic stroke

Time Frame: 2 years

Clinical symptoms related to neurological deficits in patients and/or discovery of new infarcted lesions on head magnetic resonance imaging/computed tomography scans

The recurrence of ischemic stroke

Time Frame: 2 years

Clinical symptoms related to neurological deficits in patients and/or discovery of new infarcted lesions on head magnetic resonance imaging/computed tomography scans

Study Sites (2)

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