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A Cohort Study on Cardiovascular and Cerebrovascular Outcomes

Sun Yat-sen University logo

Sun Yat-sen University

Status

Invitation-only

Conditions

Atheroscleroses
Stroke

Treatments

Combination Product: ultrasound scanning

Study type

Observational

Funder types

Other

Identifiers

NCT07178015
II2025-114-02

Details and patient eligibility

About

A standardized tool for grading carotid atherosclerotic plaques-dubbed Carotid Plaque-RADS (Reporting and Data System)-has recently been developed. Ultrasound (US) is one of the most frequently utilized methods in carotid screening worldwide. However, the clinical utility of US-based carotid plaque-RADS in refining stroke risk stratification beyond conventional stenosis grading has not been thoroughly validated. This study intends to conduct a bidirectional cohort study. In the retrospective part, we will collect relevant clinical data of patients and combine the Plaque-RADS scoring system to establish a risk regression prediction model for cardiovascular and cerebrovascular events in patients with carotid plaques. We will also prospectively collect a batch of patient data and incorporate ultrasound vector flow imaging and vascular hardness analysis to conduct a prospective cohort study, and further verify the accuracy and effectiveness of the model. Through this research, we aim to identify high-risk patients early, provide early intervention and treatment for high-risk individuals, and reduce the mortality and disability rates of cardiovascular and cerebrovascular diseases.

Enrollment

855 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients with asymptomatic carotid plaques

Exclusion criteria

  • suboptimal image quality or insufficiently detailed examination affecting analysis accuracy;
  • recent hemorrhagic cerebral infarction, intracranial hemorrhage, or intracranial neoplasms;
  • a prior history of neck radiotherapy or ipsilateral carotid artery surgical/stent procedures;
  • lost to follow-up monitoring or had an estimated survival time <12 months.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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