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
• Status: Enrolling by invitation
• 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
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Abnormalities
• Congenital Abnormalities
• Heart Diseases
• Heart Murmurs
• Heart Valve Diseases
• Valvular Heart Disease

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