Clinical trial NCT06070298: Can a Smartphone Listen to Your Heart? A Performance Study on Detecting Abnormalities in Your Heart Sounds
Official title: Smartphone-Based Use of Phonocardiography Technique for Detection of Murmurs: Diagnostic Performance Study Protocol
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Valvular Heart Disease
Heart Murmurs
Cardiovascular Abnormalities
Keywords: Auscultation
Smartphone
Heart Sounds
Heart Auscultation
Phonocardiography
Stethoscopes
Telemedicine
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Laboratory of Data Discovery for Health
name: The University of Hong Kong
First posted: 2023-10-06
Enrollment: 577
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth
timeFrame: Day 0
measure: Specificity of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth
timeFrame: Day 0
Secondary outcomes:
measure: Sensitivity of ausculto™ Using Auscultation as Ground Truth
timeFrame: Day 0
measure: Specificity of ausculto™ Using Auscultation as Ground Truth
timeFrame: Day 0
measure: Sensitivity of ausculto™ Using Echocardiography as Ground Truth
timeFrame: Day 0
measure: Specificity of ausculto™ Using Echocardiography as Ground Truth
timeFrame: Day 0
measure: Positive Predictive Value of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth
timeFrame: Day 0
measure: Negative Predictive Value of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth
timeFrame: Day 0
measure: Positive Predictive Value of ausculto™ Using Auscultation as Ground Truth
timeFrame: Day 0
measure: Negative Predictive Value of ausculto™ Using Auscultation as Ground Truth
timeFrame: Day 0
measure: Positive Predictive Value of ausculto™ Using Echocardiography as Ground Truth
timeFrame: Day 0
measure: Negative Predictive Value of ausculto™ Using Echocardiography as Ground Truth
timeFrame: Day 0
measure: Number of Adverse Events Reported by Participants Deemed to be Caused by the Observational Procedures
timeFrame: Day 0 to Day 1
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
state: Hong Kong SAR
Study officials:
affiliation: The University of Hong Kong
name: Chun Ka Wong, MBBS
role: PRINCIPAL_INVESTIGATOR
References: