Valvular Heart DiseaseAUSC1NCT06070298
Can a Smartphone Listen to Your Heart? A Performance Study on Detecting Abnormalities in Your Heart Sounds
An observational study of Valvular Heart Disease and Heart Murmurs, run by Wong Chun Ka at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Valvular Heart Disease, Heart Murmurs, Cardiovascular Abnormalities
- What is being tested?
- Computer algorithms
- How many people
- 577 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to May 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age: ≥22 years (adult)
- Outpatients who have undergone echocardiography within 3 years at their normal non-research follow-up clinic visit appointment
Who cannot join
- Implanted active medical devices in the torso, such as pacemakers and defibrillators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smartphone-Based Use of Phonocardiography Technique for Detection of Murmurs: Diagnostic Performance Study Protocol
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.
- Being tested
- Computer algorithms
- Keywords
- Auscultation, Smartphone, Heart Sounds, Heart Auscultation, Phonocardiography, Stethoscopes, Telemedicine
- Medical subject headings
- Heart Valve Diseases, Heart Murmurs, Cardiovascular Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer algorithmsDiagnostic test
Also called ausculto™, Vitogram™
Collection of lightweight computer algorithms called ausculto™ that is designed to perform real-time heart sound analysis to detect heart murmur.
| Study group | Role | What they receive |
|---|---|---|
| Abnormal Echocardiography Diagnosis | Participants with abnormal echocardiography diagnosis within three years. Receives: Diagnostic Test: Computer algorithms | |
| Normal Echocardiography Diagnosis | Participants with normal echocardiography diagnosis within three years. Receives: Diagnostic Test: Computer algorithms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0
Number of Adverse Events Reported by Participants Deemed to be Caused by the Observational Procedures
Measured: Day 0 to Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Dec 2023
- Primary completion7 Apr 2025
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 577 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Wong Chun Ka
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratory of Data Discovery for Health, The University of Hong Kong
- Responsible party
- Sponsor-investigator, Wong Chun Ka, The University of Hong Kong
- Investigators
- Chun Ka Wong, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070298
- Sponsor's protocol ID
- AUSC1
- Acronym
- AUSC1
- Status last verified
- Apr 2025
- First submitted
- 29 Sep 2023
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-Based Use of Phonocardiography Technique for Detection of Murmurs: Diagnostic Performance Study Protocol
- ClinicalTrials.gov ID
- NCT06070298
- Acronym / sponsor ID
- AUSC1 / AUSC1
- Keywords
- Auscultation, Smartphone, Heart Sounds, Heart Auscultation, Phonocardiography, Stethoscopes, Telemedicine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 577 participants (estimated)
- Lead sponsor
- Wong Chun KaUniversity, hospital or other
- Collaborators
- Laboratory of Data Discovery for Health, The University of Hong Kong
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- May 2025 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abnormal Echocardiography Diagnosis | – | Diagnostic Test: Computer algorithmsParticipants with abnormal echocardiography diagnosis within three years. |
| Normal Echocardiography Diagnosis | – | Diagnostic Test: Computer algorithmsParticipants with normal echocardiography diagnosis within three years. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age: ≥22 years (adult)
- Outpatients who have undergone echocardiography within 3 years at their normal non-research follow-up clinic visit appointment
Key exclusion criteria (1 listed)
- Implanted active medical devices in the torso, such as pacemakers and defibrillators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer algorithmsAlso: ausculto™, Vitogram™Collection of lightweight computer algorithms called ausculto™ that is designed to perform real-time heart sound analysis to detect heart murmur. | Diagnostic test | Abnormal Echocardiography Diagnosis, Normal Echocardiography Diagnosis |
Primary outcome
Sensitivity of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth
Time frame: 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
Time frame: 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.
11 secondary outcomes
Sensitivity of ausculto™ Using Auscultation as Ground Truth
Time frame: Day 0
Specificity of ausculto™ Using Auscultation as Ground Truth
Time frame: Day 0
Sensitivity of ausculto™ Using Echocardiography as Ground Truth
Time frame: Day 0
Specificity of ausculto™ Using Echocardiography as Ground Truth
Time frame: Day 0
Positive Predictive Value of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth
Time frame: Day 0
Negative Predictive Value of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth
Time frame: Day 0
Positive Predictive Value of ausculto™ Using Auscultation as Ground Truth
Time frame: Day 0
Negative Predictive Value of ausculto™ Using Auscultation as Ground Truth
Time frame: Day 0
Positive Predictive Value of ausculto™ Using Echocardiography as Ground Truth
Time frame: Day 0
Negative Predictive Value of ausculto™ Using Echocardiography as Ground Truth
Time frame: Day 0
Number of Adverse Events Reported by Participants Deemed to be Caused by the Observational Procedures
Time frame: Day 0 to Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun Ka Wong, MBBS principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Heart Disease and Heart Murmurs, run by Wong Chun Ka at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.