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临床试验/NCT06009718
NCT06009718招募中不适用

A Deep-learning-based Multi-modal Phonocardiogram(PCG) and Electrocardiogram(ECG) Processing Framework for Screening Depressed Left Ventricular Ejection Fraction (dLVEF) Using a Wearable Cardiac Patch

Ruijin Hospital3 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2023年8月25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
3,000
试验地点
3
主要终点
Determination of Heart Failure Disease

研究概览

简要总结

The diagnosis of depressed left ventricular ejection fraction (dLVEF) (EF<50%) depends on golden standard ultrasound cardiography (UCG). A wearable synchronized phonocardiography (PCG) and electrocardiogram (ECG) device can assist in the diagnosis of dLVEF, which can both expedite access to life-saving therapies and reduce the need for costly testing.

详细描述

The synchronized PCG and ECG is wirelessly paired with the WenXin Mobile application, allowing for simultaneous recording and visualization of PCG and ECG. These features uniquely enable this device to accumulate large sets of acoustic data on patients both with and without heart failure(HF).

This study is a Case-control study. In this study, the investigators seek to develop an artificial intelligence (AI) analysis system to identify dLVEF (EF<50%) by PCG and ECG. All adults (aged ≥18 years) planned for UCG were eligible to participate (inpatients and outpatients). Specifically, the investigators will attempt to develop machine learning algorithms to learn synchronized PCG and ECG of patients with dLVEF. Then we use these algorithms to identify dLVEF subjects. The investigators anticipate to demonstrate the wearable cardiac patch with synchronized PCG and ECG can reliably and accurately diagnose dLVEF in the primary care setting.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Attendance at RuiJin hospital for UCG
  • Signed dated informed consent
  • Commit to follow the research procedures and cooperate in the implementation of the whole process research
  • UCG has been completed
  • At least 8 consecutive cycles of sinus rhythm can be recorded

排除标准

  • Patients with pacemakers
  • Complete left bundle branch block or block or QRS wave widening>120ms
  • Left chest skin damaged or allergic to patch
  • Refusal to participate

结局指标

主要结局

Determination of Heart Failure Disease

时间窗: one time assessment at baseline (approx. 5 minutes)

Heart Failure Disease was determined by EMAT (millisecond, ms)calculate from synchronized PCG and ECG signals using an artificial intelligence (AI) guided model.

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

RUIYAN ZHANG

Director of Cardiology Department, Chief Physician

Ruijin Hospital

研究点 (3)

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