NCT06009718

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Timeline

• Start date: 2023-08-25
• Primary completion: 2027-06-01
• Completion: 2028-06-01
• First posted: 2023-08-24
• Last updated: 2025-01-16

Locations

3 sites across 1 country: China