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OpenTrials
Enrolling by Invitation

NCT Number: NCT07178015

A Cohort Study on Cardiovascular and Cerebrovascular Outcomes

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.

Enrolling by Invitation

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ultrasound scanning

Combination Product

Ultrasound (US) is one of the most frequently utilized methods in carotid screening worldwide, because of its noninvasive and radiation-free nature and advantages of cost-effectiveness and convenience。

Primary outcomes

  1. the occurrence of symptomatic events

    Time frame: 12 months after carotid ultrasound examinations

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Plaque-RADS Combined With Vector Flow Imaging in Assessing Carotid Atherosclerotic Risk

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Sep 17, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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