A Cohort Study on Cardiovascular and Cerebrovascular Outcomes

NCT ID: NCT07178015

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 855 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-30
• Study Completion Date: 2027-12-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

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。

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jia Liu

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

II2025-114-02

Identifier Type: -

Identifier Source: org_study_id