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Cardiovascular Acoustics and an Intelligent Stethoscope

Cardiovascular Acoustics and an Intelligent Stethoscope. An Observational Study to Collect Heart Sound Recordings From Patients to Understand the Acoustic Characteristics of Murmurs and Develop an Artificially Intelligent Stethoscope.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04445012
Acronym
CAIS
Enrollment
1150
Registered
2020-06-24
Start date
2019-10-24
Completion date
2023-01-31
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valve Diseases

Brief summary

The aim of the project is to develop an artificial intelligence software capable of analysing heart sounds to provide early diagnosis of a variety heart diseases at an early stage. Since the invention of the stethoscope by Laennec in 1816, the basic design has not changed significantly. Our software could be coupled with existing electronic stethoscopes to create an 'intelligent' stethoscope that could be used by healthcare assistants or practice nurses to screen for sound producing heart diseases. It could also be used at home by patients who would otherwise go undiagnosed. The study investigators at Cambridge University Engineering Department (CUED) have developed a proof-of-concept AI algorithm to detect heart murmurs. However, in order to accurately detect the specific pathology and severity underlying the murmur, more heart sound recordings (matched with the ground truth from the patient's echocardiogram) are required. Patients presenting to one of the partner hospitals requiring an echocardiogram as part of their routine care will be invited to consent to this study. Participation will entail recording of a patient's heart sounds using an electronic stethoscope as well as collection of routine clinical data and a routine clinical echocardiogram at a single routine out patient visit.

Detailed description

This project will develop an AI algorithm which can be imported into a stethoscope to make it capable of automatically diagnosing any valve disease present and its severity. This will help GPs produce more accurate diagnoses, reduce costs by having fewer unnecessary referrals for echocardiogram, and produce more accurate diagnoses in countries where echocardiograms are not readily available due to their cost. Using a small sample of data as well as some which has been labelled by clinician auscultation, the team has created an award-winning AI algorithm capable of accurate detection of heart murmurs. However, in order to improve the accuracy and capability of this system more heart sound recordings from a range of diseases (matched with echocardiogram diagnosis) are required. The key to the success of this study will be to produce an AI algorithm that is more accurate than different grades of doctors at detecting the specific abnormality and severity underlying a heart murmur. This methodology will also provide a comprehensive study on acoustic characteristics of different heart sounds. So far all the acoustic characteristics of heart sounds taught to medical students are based on subjective opinion. This study will be able to objectively analyse these acoustic characteristics.

Interventions

None listed

Sponsors

Papworth Hospital NHS Foundation Trust
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Days to No maximum
Healthy volunteers
No

Inclusion criteria

* Participant willing and able to give informed consent for participation in study * Participant to undergo an echocardiogram as part of their routine assessment

Exclusion criteria

* Informed consent is not given * New York Heart Association (NYHA) functional class = 4

Design outcomes

Primary

MeasureTime frameDescription
To assess specificity of an algorithm for detecting clinically significant valve disease and congenital heart disease relative to the performance of General PractitionersDay 1We will obtain 4, 15 second heart sound recordings from patients (at the Aortic, Pulmonary, Mitral, and Tricuspid sites) using a Littmann 3200 electronic stethoscope.

Countries

United Kingdom

Contacts

Primary ContactNicky Watson, MSc
nicky.watson2@nhs.net01223639684
Backup ContactVictoria Hughes, PhD
victoria.hughes1@nhs.net01223 639678

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026