A Cohort Study on Cardiovascular and Cerebrovascular Outcomes

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07178015

Enrollment

855

Registered

2025-09-17

Start date

2021-12-30

Completion date

2027-12-30

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atheroscleroses, Stroke

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.

Interventions

COMBINATION_PRODUCTultrasound 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。

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
the occurrence of symptomatic events	12 months after carotid ultrasound examinations

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026