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

Study Overview
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Brief Summary
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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.

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

Conditions
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Valvular Heart Disease, Heart Murmurs, Cardiovascular Abnormalities

Intervention / Treatment
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* Diagnostic Test: Computer algorithms


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Abnormal Echocardiography Diagnosis<br>Participants with abnormal echocardiography diagnosis within three years. | Diagnostic Test: Computer algorithms<br>* Collection of lightweight computer algorithms called ausculto™ that is designed to perform real-time heart sound analysis to detect heart murmur.<br>* Other names: Vitogram™;|
| Normal Echocardiography Diagnosis<br>Participants with normal echocardiography diagnosis within three years. | Diagnostic Test: Computer algorithms<br>* Collection of lightweight computer algorithms called ausculto™ that is designed to perform real-time heart sound analysis to detect heart murmur.<br>* Other names: Vitogram™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Number of Adverse Events Reported by Participants Deemed to be Caused by the Observational Procedures |  | Day 0 to Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Auscultation, Smartphone, Heart Sounds, Heart Auscultation, Phonocardiography, Stethoscopes, Telemedicine