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.

NCT Number	NCT07178015
Lead Sponsor	Sun Yat-sen University
Conditions	Stroke, Atheroscleroses
Enrollment	855 participants
Start Date	2021-12-30
Primary Completion	2025-12-30 (estimated)
Study Completion	2027-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-12-15