NCT07178015

A Cohort Study on Cardiovascular and Cerebrovascular Outcomes

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 855 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stroke
• Atheroscleroses

Interventions

Type	Name	Description
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。

Timeline

• Start date: 2021-12-30
• Primary completion: 2025-12-30
• Completion: 2027-12-30
• First posted: 2025-09-17
• Last updated: 2025-12-15

Locations

1 site across 1 country: China