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

Active, not recruiting

• Conditions: Heart Murmurs; Cardiovascular Abnormalities; Valvular Heart Disease
• Interventions: Diagnostic Test: Computer algorithms

• Registration Number: NCT06070298
• Lead Sponsor: Wong Chun Ka

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-29
• Study First Submitted QC: 2023-09-29
• Study First Posted: 2023-10-06
• Study Start: 2023-12-01
• Status Verified: 2025-04
• Primary Completion: 2025-04-07
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 577

Inclusion Criteria

• Age: ≥22 years (adult)
• Outpatients who have undergone echocardiography within 3 years at their normal non-research follow-up clinic visit appointment

Exclusion Criterion:

• Implanted active medical devices in the torso, such as pacemakers and defibrillators

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abnormal Echocardiography Diagnosis	Computer algorithms	Participants with abnormal echocardiography diagnosis within three years.
Normal Echocardiography Diagnosis	Computer algorithms	Participants with normal echocardiography diagnosis within three years.

Primary Outcome Measures

Name	Time	Method
Sensitivity of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth	Day 0	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.
Specificity of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth	Day 0	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.

Secondary Outcome Measures

Name	Time	Method
Sensitivity of ausculto™ Using Auscultation as Ground Truth	Day 0	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 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.
Specificity of ausculto™ Using Echocardiography as Ground Truth	Day 0	Specificity is defined as the percentage of true negatives out of all negative cases from the ground truth. Echocardiography diagnosis will be used as the ground truth.
Negative Predictive Value of ausculto™ Using Echocardiography as Ground Truth	Day 0	Negative predictive value is defined as the percentage of true negatives out of all negative results from ausculto™. Echocardiography diagnosis will be used as the ground truth.
Sensitivity of ausculto™ Using Echocardiography as Ground Truth	Day 0	Sensitivity is defined as the percentage of true positives out of all positive cases from the ground truth. Echocardiography diagnosis will be used as the ground truth.
Specificity of ausculto™ Using Auscultation as Ground Truth	Day 0	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 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.
Negative Predictive Value of ausculto™ Using Auscultation as Ground Truth	Day 0	Negative predictive value is defined as the percentage of true negatives out of all negative results from ausculto™. Cardiologist electronic stethoscope heart sound recording annotations 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.
Positive Predictive Value of ausculto™ Using Echocardiography as Ground Truth	Day 0	Positive predictive value is defined as the percentage of true positives out of all positive results from ausculto™. Echocardiography diagnosis will be used as the ground truth.
Number of Adverse Events Reported by Participants Deemed to be Caused by the Observational Procedures	Day 0 to Day 1
Positive Predictive Value of ausculto™ Using Auscultation as Ground Truth	Day 0	Positive predictive value is defined as the percentage of true positives out of all positive results from ausculto™. Cardiologist electronic stethoscope heart sound recording annotations 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.
Positive Predictive Value of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth	Day 0	Positive predictive value is defined as the percentage of true positives out of all positive results from ausculto™. 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.
Negative Predictive Value of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth	Day 0	Negative predictive value is defined as the percentage of true negatives out of all negative results from ausculto™. 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.

Trial Locations

Locations (1)

Queen Mary Hospital; 🇨🇳 Hong Kong, Hong Kong SAR, China