By InvitationNot Applicable

A Cohort Study on Cardiovascular and Cerebrovascular Outcomes

China855 participantsStarted 2021-12-30

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

the occurrence of symptomatic events

Timeframe: 12 months after carotid ultrasound examinations

Trial details

NCT IDNCT07178015

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-30

View on ClinicalTrials.gov More Stroke trials