Cardiovascular Acoustics and an Intelligent Stethoscope

NCT ID: NCT04445012

Last Updated: 2021-09-16

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

1150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-24

Study Completion Date

2023-01-31

Brief Summary

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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

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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.

Conditions

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Heart Valve Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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 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
Minimum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Papworth Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Royal Papworth Hospital NHS Foundation Trust

Cambridge, , United Kingdom

Site Status RECRUITING

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

King's College Hospital NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Nicky Watson, MSc

Role: CONTACT

01223639684

Victoria Hughes, PhD

Role: CONTACT

01223 639678

Facility Contacts

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Rick Steeds, MA, MBBS, MD

Role: primary

Len Shapiro, MB BChir MD

Role: primary

Shakeel Qureshi, MBCHB, MRCP

Role: primary

Mark Monaghan, MSc, PhD

Role: primary

Bushra Rana, MB BS

Role: primary

Other Identifiers

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P02087

Identifier Type: -

Identifier Source: org_study_id

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