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NCT Number: NCT06009718

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiaotong School of Medicine, Shanghai, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Determination of Heart Failure Disease

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bei Song, MD

CONTACT

[email protected]

+86 21 15821960139

Wenli Zhang, MD

CONTACT

[email protected]

+86 21 13917615339

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Aug 24, 2023
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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