Artificial Intelligence (AI) Analysis of Synchronized Phonocardiography (PCG) and Electrocardiogram(ECG)

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT06009718
• Lead Sponsor: Ruijin Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-08-19
• Study First Posted: 2023-08-24
• Study Start: 2023-08-25
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16
• Primary Completion: 2027-06-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• 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
• Age ≥ 18
• At least 8 consecutive cycles of sinus rhythm can be recorded

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of Heart Failure Disease	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.

Trial Locations

Locations (3)

Ruijin Hospital, Shanghai Jiaotong School of Medicine; 🇨🇳 Shanghai, China

Shanghai Chest Hospital, Shanghai Jiao Tong University School Of Medicine; 🇨🇳 Shanghai, China

Shanghai East Hospital; 🇨🇳 Shanghai, China