Cardiovascular Acoustics and an Intelligent Stethoscope
NCT ID: NCT04445012
Last Updated: 2021-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1150 participants
OBSERVATIONAL
2019-10-24
2023-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Aortic Valve Stenosis (Adults)
30 patients with mild, 30 with moderate, and 30 with severe mitral regurgitation, using the BSE gradings \[Wharton 2014\].
No interventions assigned to this group
Mitral Valve Regurgitation (Adults)
30 patients with mild, 30 with moderate, and 30 with severe mitral regurgitation, using the BSE gradings \[Wharton 2014\].
No interventions assigned to this group
Aortic Regurgitation (Adults)
30 patients with mild, 30 with moderate, and 30 with severe aortic regurgitation, using the BSE gradings \[Wharton 2014\].
No interventions assigned to this group
Mitral Stenosis (Adults)
30 patients with mild, 30 with moderate, and 30 with severe mitral stenosis, using the BSE gradings \[Wharton 2014\].
No interventions assigned to this group
Mixed Valve Disease (Adults)
30 patients with mild, 30 with moderate, and 30 with severe mixed valve disease. Overall classification based on the most severe disease using the BSE gradings \[Wharton 2014\].
No interventions assigned to this group
Ventricular Septal Defects (Paediatric Patients)
36 paediatric patients with mild, 37 with moderate, and 36 with severe ventricular septal defects, using gradings from \[Samaan 1970\].
No interventions assigned to this group
Aortic Stenosis (Paediatric Patients)
36 paediatric patients with mild, 37 with moderate, and 36 with severe aortic stenosis
No interventions assigned to this group
Pulmonary Stenosis (Paediatric Patients)
36 paediatric patients with mild, 37 with moderate, and 36 with severe pulmonary stenosis.
No interventions assigned to this group
Patent Ductus Arteriosus (Paediatric Patients)
36 paediatric patients with mild, 37 with moderate, and 36 with severe patent ductus arteriosus, graded using ductal size \[Arlettaz 2017\].
No interventions assigned to this group
No Disease (Paediatric Patients)
264 paediatric patients with no heart disease. Note that we are only taking recordings from those who have been referred for an echocardiogram with a suspected heart condition but are subsequently found to have no heart disease.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Participant to undergo an echocardiogram as part of their routine assessment
Exclusion Criteria
* New York Heart Association (NYHA) functional class = 4
14 Days
ALL
No
Sponsors
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Papworth Hospital NHS Foundation Trust
OTHER_GOV
Responsible Party
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Principal Investigators
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Bushra Rana, MB BS
Role: PRINCIPAL_INVESTIGATOR
Imperial College Healthcare NHS Trust
Locations
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University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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P02087
Identifier Type: -
Identifier Source: org_study_id
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