跳至主要内容
临床试验/NCT05884008
NCT05884008招募中不适用

Coronary Computed Tomography Angiography and Functional Analysis in Risk Stratification of Coronary Artery Disease: A Retrospective Cohort Study

Ruijin Hospital9 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
9
主要终点
Coronary artery plaque risk level

研究概览

简要总结

This study is a multicenter, retrospective imaging study. The study intends to retrospectively enroll patients with acute myocardial infarction who had received coronary CTA in a certain time-window before this event. All coronary CTA will be analyzed by anatomic, functional and radiomic analysis, assisted by artificial intelligence. The purpose of this study is to establish a coronary artery disease risk stratification system by coronary CTA.

详细描述

Coronary angiography has been the gold standard for the diagnosis of coronary heart disease and PCI decision-making. However, the value of CAG in risk stratification is limited due to its invasive nature and lack of ability to evaluate coronary physiology and plaque characteristics, which often leads to over-treatment or under-treatment. In recent years, with the development and improvement of imaging technology, the resolution and diagnostic accuracy of coronary artery CTA have been greatly improved, and the subsequent anatomy and function (non-invasive CT-FFR, etc.) have made the assessment of coronary artery lesion risk multi-dimensional. Comprehensive and accurate coronary artery CTA scan plays a positive role in establishing the appropriate standard for PCI and improving the prognosis of patients. However, the existing problems of coronary artery CTA are insufficient imaging studies, complex image analysis, inconsistent diagnostic criteria, and insufficient clinical evidence. This study is one of the series of clinical studies on the topic of "Risk Evaluation by COronary Computed Tomography and Artificial Intelligence Based fuNctIonal analyZing tEchniques (RECOGNIZE)". The purpose of the study is to establish a coronary artery disease risk stratification system by coronary CTA and anatomic, functional and radiomic analysis, assisted by artificial intelligence.

研究设计

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

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

入选标准

  • Age between 18-80 years old
  • Received coronary CT angiography 3 months to 5 years prior to acute coronary myocardial infarction. CCTA identified coronary atherosclerotic plaques with diameter stenosis ≥ 10%

排除标准

  • Familial hypercholesterolemia
  • Prior history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
  • Prior history of myocardial infarction before the recent event
  • Severe liver or renal insufficiency

结局指标

主要结局

Coronary artery plaque risk level

时间窗: 3 months to 5 years prior to acute myocardial infarction

Coronary plaque risk was determined using an artificial intelligence (AI) guided risk stratification model based on Coronary CTA structural, functional and radiomic analysis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

RUIYAN ZHANG

Director of Cardiology Department, Principal Investigator

Ruijin Hospital

研究点 (9)

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