跳至主要内容
临床试验/CTRI/2025/12/098910
CTRI/2025/12/098910尚未招募不适用

A multicenter study to demonstrate compatibility of ECG-AI acress 12-Lead ECG devices

Anumana Inc.2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2026年1月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
试验地点
2

研究概览

简要总结

Electrocardiograms (ECGs) are among the most widely performed diagnostic tests in medicine due to their affordability, accessibility, and utility in detecting cardiovascular disease. However, the diversity of ECG hardware across manufacturers introduces the potential for device-specific variability in signal characteristics, which could affect the performance of downstream ECG-based artificial intelligence (ECG-AI) algorithms. Despite the high sensitivity and specificity of some ECG-AI tools, their clinical applicability may be limited by lack of generalizability across devices. To study the extent of this limitation, we aim to compare the output of multiple ECG-AI models across a range of ECG machines.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Adult subjects (age 18 or older).

排除标准

  • No subject consent obtained
  • Open chest wounds or recent surgery to the chest or abdomen (less than 30 days)
  • Absence of any limb that would require modification of standard lead placement.

研究者

发起方
Anumana Inc.
申办方类型
Other [Health-technology company]
责任方
Principal Investigator
主要研究者

Dr Santosh Saklecha

Santosh Hospital

研究点 (2)

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