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NCT06070298 Clinical Trial

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

Valvular Heart Disease Clinical Trial

Official title:
Smartphone-Based Use of Phonocardiography Technique for Detection of Murmurs: Diagnostic Performance Study Protocol

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06070298
Other study ID # AUSC1
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date December 2024

Study information
Verified date December 2023
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 577
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers
Gender All
Age group 22 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Queen Mary Hospital Hong Kong Hong Kong SAR

Sponsors (3)
Lead Sponsor Collaborator
Wong Chun Ka Laboratory of Data Discovery for Health, The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Sensitivity of ausculto™ Using Auscultation 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 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 Specificity of ausculto™ Using Auscultation 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 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 Sensitivity of ausculto™ Using Echocardiography as Ground Truth 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. Day 0
Secondary Specificity of ausculto™ Using Echocardiography as Ground Truth 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. Day 0
Secondary Positive Predictive Value of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth 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. Day 0
Secondary Negative Predictive Value of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth 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. Day 0
Secondary Positive Predictive Value of ausculto™ Using Auscultation as Ground Truth 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. Day 0
Secondary Negative Predictive Value of ausculto™ Using Auscultation as Ground Truth 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. Day 0
Secondary Positive Predictive Value of ausculto™ Using Echocardiography as Ground Truth 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. Day 0
Secondary Negative Predictive Value of ausculto™ Using Echocardiography as Ground Truth 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. Day 0
Secondary Number of Adverse Events Reported by Participants Deemed to be Caused by the Observational Procedures Day 0 to Day 1
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