跳至主要内容
临床试验/NCT05856110
NCT05856110招募中不适用

Coronary Computed Tomography Angiography and Functional Analysis in Risk Stratification of Coronary Artery Disease: A Prospective, Multi-center Cohort Study

Ruijin Hospital9 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2023年7月3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
2,000
试验地点
9
主要终点
Major Adverse Cardiovascular Events

研究概览

简要总结

This study is a multicenter, prospective clinical cohort study. The study intends to continuously enroll patients with coronary heart disease. All subjects will undergo coronary CTA (followed by anatomic, functional and radiomics analysis), proteomics research as well as clinical follow-up of cardiovascular events. The purpose of this study is to establish a new, non-invasive cardiovascular disease risk stratification system.

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 evaluate the accuracy of early identification of cardiovascular high-risk groups based on the functional evaluation model based on coronary CTA images through a multi-center, prospective clinical cohort study, so as to establish an early, non-invasive and accurate risk classification of cardiovascular events in coronary heart disease.

研究设计

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

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 18-80 years
  • Clinically significant angina pectoris, suspecting coronary artery disease

排除标准

  • Unsuitable for coronary CTA (such as severe renal impairment, uncontrolled thyroid condition, allergic to iodine, etc.)
  • Without a visible plaque (defined as ≥ 30% stenosis) in major coronary arteries in coronary CTA
  • Prior history of myocardial infarction or heart failure
  • Prior history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
  • Severe renal or liver failure
  • Familial hypercholesterolemia
  • Estimated survival ≤1 year
  • Malignant tumor
  • Poor coordinance, unable to follow-up

结局指标

主要结局

Major Adverse Cardiovascular Events

时间窗: 2 years

Including cardiovascular death, myocardial infarction, and stroke

次要结局

  • Myocardial infarction(2 years)
  • Cardiovascular death(2 years)
  • Stroke(2 years)
  • Coronary Revascularization(2 years)

研究者

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

RUIYAN ZHANG

Director of Cardiology, Director of cardiovascular catherization lab, Principle Investigator

Ruijin Hospital

研究点 (9)

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