跳至主要内容
临床试验/NCT07178015
NCT07178015Enrolling By Invitation不适用

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

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 855 人开始时间: 2021年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
855
试验地点
1
主要终点
the occurrence of symptomatic events

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients with asymptomatic carotid plaques

排除标准

  • •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.

结局指标

主要结局

the occurrence of symptomatic events

时间窗: 12 months after carotid ultrasound examinations

次要结局

未报告次要终点

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jia Liu

Clinical Professor

Sun Yat-sen University

研究点 (1)

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