跳至主要内容
临床试验/NCT06397820
NCT06397820已完成不适用

Relation Between Artificial Intelligence (AI)-Assisted Quantitative Coronary Angiography and Positron Emission Tomography-Derived Myocardial Blood Flow

Chonnam National University Hospital1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
168
试验地点
1
主要终点
Correlation between diameter stenosis by AI-QCA and PET-driven stress MBF

研究概览

简要总结

The aim of the study is to evaluate the clinical implications of artificial Intelligence (AI)-assisted quantitative coronary angiography (QCA) and positron emission tomography (PET)-derived myocardial blood flow in clinically indicated patients.

详细描述

Percutaneous coronary angiography (CAG) is a standard method for evaluating coronary artery disease. Traditionally, a reduction in the luminal diameter of the coronary arteries by 50% or more during angiography has been considered a significant stenotic lesion. However, the assessment of coronary artery stenosis is usually based on visual estimation by the operator in daily routine clinical practice, which interferes with the objective evaluation.

Quantitative coronary angiography (QCA) has been developed to overcome this limitation. This technique involves the software-based analysis of coronary images obtained through CAG. The previous study showed that there was low concordance between the QCA and visual estimation of coronary artery stenosis (Kappa=0.63) and a reclassification rate of approximately 20%. Furthermore, visual assessments tended to overestimate the degree of coronary artery stenosis, particularly in complex lesions such as bifurcation lesions.

However, there are some limitations to adopting QCA in our daily routine practice. The QCA cannot analyze coronary images on-site and is not fully automated, requiring manual adjustments by humans. Recent advancements have led to the development of artificial intelligence (AI)-based QCA software, which achieves complete automation in the analysis process and provides real-time objective evaluations of coronary artery stenosis.

This study aims to examine the clinical significance of AI-QCA by assessing the correlation between the degree of coronary stenosis detected by AI-QCA and myocardial blood flow abnormalities observed in 13NH3-Ammonia PET scans in patients with coronary artery disease.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Correlation between diameter stenosis by AI-QCA and PET-driven stress MBF

时间窗: Immediate after AI-QCA and PET exams

Performance of AI-QCA predicting for PET-driven stress MBF

Correlation between diameter stenosis by AI-QCA and PET-driven RFR

时间窗: Immediate after AI-QCA and PET exams

Performance of AI-QCA predicting for PET-driven RFR

次要结局

  • Correlation between diameter stenosis by AI-QCA and PET-driven coronary flow reserve (CFR)(Immediate after AI-QCA and PET exams)
  • Correlation between diameter stenosis by AI-QCA and PET-driven semi-quantitative markers of ischemia(Immediate after AI-QCA and PET exams)
  • Myocardial infarction(1 year after last patient enrollment)
  • Correlation between diameter stenosis by AI-QCA and PET-driven coronary flow capacity (CFC)(Immediate after AI-QCA and PET exams)
  • Cardiovascular death(1 year after last patient enrollment)
  • Rate of target vessel revascularization(1 year after last patient enrollment)
  • All-cause death(1 year after last patient enrollment)
  • Rate of cerebrovascular accident(1 year after last patient enrollment)
  • Rate of stent thrombosis(1 year after last patient enrollment)
  • Rate of target lesion revascularization(1 year after last patient enrollment)
  • Rate of any revascularization(1 year after last patient enrollment)
  • Major adverse cerebrocardiovascular event (MACCE)(1 year after last patient enrollment)

研究者

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

Seung Hun Lee

Assistant Professor

Chonnam National University Hospital

研究点 (1)

Loading locations...

相似试验

Relation Between AI-QCA and Cardiac PET | 临床试验