Detection of Valvular Heart Disease Using Artificial Intelligence-based Stethoscope

April 24, 2024 updated by: Xiao-dong Zhuang
The aim of this study is to develop a deep learning-based application of heart sounds in the diagnosis of valvular heart disease, which can be used to screen patients with valvular heart disease and promote earlier clinical monitoring and intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • First Affiliated Hospital, Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

patients with and without valvular heart disease assessed by echocardiography

Description

Inclusion Criteria:

  1. age>18 years
  2. In the past 1 month, echocardiography was performed to diagnose valvular heart disease (positive group) and echocardiography to exclude valvular heart disease (negative group).
  3. Consent to study and be able to sign informed consent

Exclusion Criteria:

  1. After prosthetic valve replacement
  2. Congenital heart disease (except bilobal aortic valve)
  3. Hypertrophic Cardiomyopathy（HCM）
  4. Pregnant, lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with valvular heart disease
Other: artificial intelligence-based stethoscope
artificial intelligence-based stethoscope
patients without valvular heart disease
Other: artificial intelligence-based stethoscope
artificial intelligence-based stethoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
valvular heart disease
Time Frame: 10 months
Reports therefore graded VHD as none, mild, moderate, severe, or critical, with additional borderline categories (eg, moderate to severe) also allowed
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiao-dong Zhuang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stethoscope study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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