跳至主要内容
临床试验/NCT07316231
NCT07316231
招募中
不适用

Toho Multicenter Registry for Evaluating the Accuracy and Practical Utility of AI-Enhanced 12-Lead ECG in Monitoring Atrial Fibrillation

Toho University1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2025年9月11日最近更新:

概览

阶段
不适用
状态
招募中
入组人数
350
试验地点
1
主要终点
the 1-2-year composite endpoint of all-cause death and major adverse cardiac events (MACE), including AF recurrence

概览

简要总结

Atrial fibrillation (AF) is a major cause of heart failure and ischemic stroke, making early detection and intervention critically important. However, timely ECG recording during paroxysmal episodes is often difficult, leading to delayed diagnosis. Recently, an AI-enhanced 12-lead ECG equipped with a "hidden AF risk estimation" function has been introduced. This technology analyzes sinus rhythm ECGs and stratifies the likelihood of prior AF into four risk categories. Although this novel approach may facilitate earlier AF detection and optimize the timing of therapeutic intervention, its clinical accuracy and real-world utility remain insufficiently validated. Therefore, this multicenter study aims to evaluate the diagnostic performance and clinical usefulness of AI-based AF risk assessment and to clarify its association with subsequent AF incidence and patient outcomes.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Patients with atrial fibrillation or atrial tachycardia (AF/AT) in whom sinus rhythm is maintained or can be confirmed at the time of ECG recording

排除标准

  • Age \<18 years
  • History of long-standing persistent or permanent atrial fibrillation
  • Frequent premature beats preventing acquisition of a sinus rhythm ECG
  • Patients with no clinical indication to suspect atrial fibrillation

结局指标

主要结局

the 1-2-year composite endpoint of all-cause death and major adverse cardiac events (MACE), including AF recurrence

时间窗: one-two year

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

Hideki Koike

Principal Investigator

Toho University

研究点 (1)

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