Cardiovascular Acoustics and an Intelligent Stethoscope
CAIS
1 other identifier
observational
1,150
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 24, 2019
CompletedFirst Submitted
Initial submission to the registry
June 21, 2020
CompletedFirst Posted
Study publicly available on registry
June 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedSeptember 16, 2021
September 1, 2021
2.4 years
June 21, 2020
September 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
To assess specificity of an algorithm for detecting clinically significant valve disease and congenital heart disease relative to the performance of General Practitioners
We will obtain 4, 15 second heart sound recordings from patients (at the Aortic, Pulmonary, Mitral, and Tricuspid sites) using a Littmann 3200 electronic stethoscope.
Day 1
Study Arms (10)
Aortic Valve Stenosis (Adults)
30 patients with mild, 30 with moderate, and 30 with severe mitral regurgitation, using the BSE gradings \[Wharton 2014\].
Mitral Valve Regurgitation (Adults)
30 patients with mild, 30 with moderate, and 30 with severe mitral regurgitation, using the BSE gradings \[Wharton 2014\].
Aortic Regurgitation (Adults)
30 patients with mild, 30 with moderate, and 30 with severe aortic regurgitation, using the BSE gradings \[Wharton 2014\].
Mitral Stenosis (Adults)
30 patients with mild, 30 with moderate, and 30 with severe mitral stenosis, using the BSE gradings \[Wharton 2014\].
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 \[Wharton 2014\].
Ventricular Septal Defects (Paediatric Patients)
36 paediatric patients with mild, 37 with moderate, and 36 with severe ventricular septal defects, using gradings from \[Samaan 1970\].
Aortic Stenosis (Paediatric Patients)
36 paediatric patients with mild, 37 with moderate, and 36 with severe aortic stenosis
Pulmonary Stenosis (Paediatric Patients)
36 paediatric patients with mild, 37 with moderate, and 36 with severe pulmonary stenosis.
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 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.
Eligibility Criteria
Patients attending cardiology clinics at the investigation sites who will be having an echocardiogram
You may qualify if:
- Participant willing and able to give informed consent for participation in study
- Participant to undergo an echocardiogram as part of their routine assessment
You may not qualify if:
- Informed consent is not given
- New York Heart Association (NYHA) functional class = 4
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH, United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge, CB2 0AY, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
Imperial College Healthcare NHS Trust
London, W2 1NY, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bushra Rana, MB BS
Imperial College Healthcare NHS Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2020
First Posted
June 24, 2020
Study Start
October 24, 2019
Primary Completion
March 30, 2022
Study Completion
January 31, 2023
Last Updated
September 16, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share