Cardiovascular Acoustics and an Intelligent Stethoscope (CAIS)

September 14, 2021 updated by: Papworth Hospital NHS Foundation Trust

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust
        • Contact:
      • Cambridge, United Kingdom, CB2 0AY
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital NHS Foundation Trust
        • Contact:
      • London, United Kingdom, SE1 9RT
      • London, United Kingdom, W2 1NY
        • Recruiting
        • Imperial College Healthcare NHS Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 weeks and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients attending cardiology clinics at the investigation sites who will be having an echocardiogram

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To assess specificity of an algorithm for detecting clinically significant valve disease and congenital heart disease relative to the performance of General Practitioners
Time Frame: Day 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Papworth Hospital NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bushra Rana, MB BS, Imperial College Healthcare NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 24, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P02087

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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