A Cohort Study on Cardiovascular and Cerebrovascular Outcomes

NCT07178015 | Enrolling By Invitation

• 1 other identifier: II2025-114-02
• Study Type: observational
• Target: 855
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• the occurrence of symptomatic events

  12 months after carotid ultrasound examinations

Interventions

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。

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with asymptomatic carotid plaques who underwent carotid ultrasound examinations.

You may qualify if:

• patients with asymptomatic carotid plaques

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Stroke; Atherosclerosis

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: December 30, 2021
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-09

Locations

CN (1)