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Enrolling by invitation NCT07178015

A Cohort Study on Cardiovascular and Cerebrovascular Outcomes

Observational Stroke Atheroscleroses

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ultrasound scanning.
Who it may be relevant to
Registry conditions: Stroke, Atheroscleroses. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Combination product ultrasound scanning
    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 outcome measures

  • the occurrence of symptomatic events [Time frame: 12 months after carotid ultrasound examinations]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • the Third Affiliated Hospital of Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT07178015 · II2025-114-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗