跳至主要内容
临床试验/NCT06287892
NCT06287892招募中不适用

Diagnosis of Hypertrophic Cardiomyopathy With Artificial Intelligence-enhanced Electrocardiogram

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
1
主要终点
Diagnosis of HCM with AI-ECG

研究概览

简要总结

The study aims to establish a diagnostic model of hypertrophic cardiomyopathy with artificial intelligence-enhanced electrocardiogram.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Diagnosed with HCM

排除标准

  • Patients with ventricular pacing

结局指标

主要结局

Diagnosis of HCM with AI-ECG

时间窗: 1 year within the time frame of ECG data collection

First a diagnosis of HCM is made as the standard outcome according to 1) an International Classification of Diseases (ICD) code for HCM (ICD-9425.1, 425.11, 425.18, and ICD10 I42.1, I42.2); 2) reports from the echocardiographers. An AI-ECG algorithm will be used to make a diagnosis of HCM and compared with the standard outcome. The performance of the AI-ECG algorithm will be evaluated with metrics including AU-ROC, specificity, sensitivity and F1 value.

次要结局

未报告次要终点

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yixiu Liang

Director of Department of Cardiology

Shanghai Zhongshan Hospital

研究点 (1)

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