Can a Smartphone Listen to Your Heart? A Performance Study on Detecting Abnormalities in Your Heart Sounds

NCT06070298 | Active Not Recruiting

• 1 other identifier: AUSC1
• Study Type: observational
• Target: 577
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to assess the performance of the software called ausculto™. ausculto™ is a collection of computer algorithms that intend to analyse heart sounds recorded from the built-in microphone of a smartphone for abnormal sounds. Participants will have their heart sounds recorded during their regular clinic appointment after consenting to participate in this study. Researchers will manually annotate the recorded heart sounds to create a database for use in future training and testing of artificial intelligence (AI) intended for medical uses.

Conditions

Valvular Heart Disease; Heart Murmurs; Cardiovascular Abnormalities

Keywords

Auscultation; Smartphone; Heart Sounds; Heart Auscultation; Phonocardiography; Stethoscopes; Telemedicine

Outcome Measures

Primary Outcomes (2)

• Sensitivity of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth

  Sensitivity is defined as the percentage of true positives out of all positive cases from the ground truth. Cardiologist electronic stethoscope heart sound recording annotations paired with echocardiography diagnosis will be used as the ground truth. Heart sound recordings from electronic stethoscope will be rated by two independent cardiologists for presence or absence of murmur, with a third cardiologist consulted in case of disagreement.

  Day 0

• Specificity of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth

  Specificity is defined as the percentage of true negatives out of all negative cases from the ground truth. Cardiologist electronic stethoscope heart sound recording annotations paired with echocardiography diagnosis will be used as the ground truth. Heart sound recordings from electronic stethoscope will be rated by two independent cardiologists for presence or absence of murmur, with a third cardiologist consulted in case of disagreement.

  Day 0

Secondary Outcomes (11)

• Sensitivity of ausculto™ Using Auscultation as Ground Truth

  Day 0

• Specificity of ausculto™ Using Auscultation as Ground Truth

  Day 0

• Sensitivity of ausculto™ Using Echocardiography as Ground Truth

  Day 0

• Specificity of ausculto™ Using Echocardiography as Ground Truth

  Day 0

• Positive Predictive Value of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth

  Day 0

Study Arms (2)

Abnormal Echocardiography Diagnosis

Participants with abnormal echocardiography diagnosis within three years.

Diagnostic Test: Computer algorithms

Normal Echocardiography Diagnosis

Participants with normal echocardiography diagnosis within three years.

Diagnostic Test: Computer algorithms

Interventions

Computer algorithms DIAGNOSTIC_TEST

Collection of lightweight computer algorithms called ausculto™ that is designed to perform real-time heart sound analysis to detect heart murmur.

Also known as: ausculto™, Vitogram™

Abnormal Echocardiography Diagnosis; Normal Echocardiography Diagnosis

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult hospital cardiology out-patients (22-year-old and above) who have undergone echocardiography within 3 years at their normal non-research follow-up clinic visit appointment.

You may qualify if:

• Age: ≥22 years (adult)
• Outpatients who have undergone echocardiography within 3 years at their normal non-research follow-up clinic visit appointment
• Implanted active medical devices in the torso, such as pacemakers and defibrillators

Sponsors & Collaborators

• Wong Chun Ka: lead
• Laboratory of Data Discovery for Health: collaborator
• The University of Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong SAR, China

Location

MeSH Terms

Conditions

Heart Valve Diseases; Heart Murmurs; Cardiovascular Abnormalities

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Chun Ka Wong, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 6, 2023
• Study Start: December 1, 2023
• Primary Completion: April 7, 2025
• Study Completion: May 1, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)