Heart MurmursNCT02512341
Automatic Differentiation of Innocent and Pathologic Murmurs in Pediatrics
An observational study of Heart Murmurs and Mitral Valve Prolapse, run by CSD Labs GmbH at 1 site in Canada.
Trial summary
The purpose of this preliminary clinical study is to assess the quality of a computational algorithm that automatically classifies murmurs of phonocardiograms (PCGs) as either pathologic (AHA class I) or as no- or innocent (AHA class III) in the pediatric population. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Murmurs, Mitral Valve Prolapse, Systolic Murmurs
- What is being tested?
- Computer Aided Auscultation (CAA)
- Type of treatment
- Medical device
- How many people
- 106 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Jun 2014
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Outpatients with and without heart defects showing pathological heart murmurs, innocent heart murmurs and heart sounds without murmurs at the cardiology department.
Who may be able to join
- outpatient
- parental approval for study participation
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this preliminary clinical study is to assess the quality of a computational algorithm that automatically classifies murmurs of phonocardiograms (PCGs) as either pathologic (AHA class I) or as no- or innocent (AHA class III) in the pediatric population.
Each patient is auscultated and diagnosed independently by a medical specialist by means of a standard mechanical stethoscope. Additionally, for each patient, a PCG is recorded using a Littmann 3200 electronic stethoscope and later analyzed using the computational algorithm. An echocardiogram is performed as the gold-standard for determining heart pathologies. The results of the computer aided auscultation (CAA) are compared to the findings of the medical professionals as well as to the echocardiogram findings.
Hypothesis: The specific CAA algorithms used in this study are able to differentiate pathologic (AHA class I) from no- or innocent murmurs (AHA class III) in a pediatric population.
Read the detailed description
Background:
Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) would be of great value to the general practitioner and potentially also to the specialist. This would allow objective screening for structural heart disease, standardized documentation of auscultation findings, and may avoid unnecessary referrals to pediatric cardiologists. Our goal was to further develop and assess the quality of a novel computational algorithm that automatically classifies murmurs of phonocardiograms (PCGs) acquired in a pediatric population.
Methods:
Patients with no-, innocent-, and pathologic murmurs were recruited from the general pediatric cardiology clinic. Using an electronic stethoscope, PCGs were acquired by the pediatric cardiologist from each patient. The PCGs were analyzed by the algorithm and diagnoses were compared to findings by the pediatric specialist and echocardiography as the gold standard.
The following registry procedures and quality factors have been implemented in this preliminary clinical study:
- Quality assurance plan, including
- data validation
- proper registration procedures
- Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (medical records and paper case report forms).
- Standard Operating Procedures to address registry operations and analysis activities, including patient recruitment, data collection, data management, data analysis.
- Conditions
- Heart Murmurs, Mitral Valve Prolapse, Systolic Murmurs
- Being tested
- Computer Aided Auscultation (CAA)
- Keywords
- Computer Aided Auscultation (CAA), Electronic Stethoscope, Phonocardiography, Heart Auscultation
- Medical subject headings
- Heart Murmurs, Mitral Valve Prolapse, Systolic Murmurs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Aided Auscultation (CAA)Device
Also called Phonocardiogram analysis, Automated heart murmur classification, Murmur screening
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of correctly diagnosed pathological heart murmurs through independent algorithm-based auscultation.
Each patient is screened and diagnosed regarding a potential heart murmur by a medical expert through standard stethoscope-based auscultation. Heart sounds are recorded using an electronic Littmann 3200 stethoscope. The resulting phonocardiograms are analyzed and diagnosed independently, offline, with no external input, by an algorithm. A final diagnosis for each patient is made by a medical expert by performing an echocardiogram, the gold standard method for heart murmur detection. The diagnoses of both the medical expert and the algorithm are finally compared to the echocardiogram-based diagnosis.
Measured: 2 months
Secondary outcomes (1)
Number of correctly diagnosed pathological heart murmurs through traditional stethoscope based auscultation by medical experts.
Each patient is screened and diagnosed regarding a potential heart murmur by a medical expert through standard stethoscope-based auscultation. Heart sounds are recorded using an electronic Littmann 3200 stethoscope. The resulting phonocardiograms are analyzed and diagnosed independently, offline, with no external input, by an algorithm. A final diagnosis for each patient is made by a medical expert by performing an echocardiogram, the gold standard method for heart murmur detection. The diagnoses of both the medical expert and the algorithm are finally compared to the echocardiogram-based diagnosis.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startNov 2013
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart MurmursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 106 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- CSD Labs GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lillian Lai, MD, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512341
- Sponsor's protocol ID
- OTT01
- Status last verified
- Jul 2018
- First submitted
- 29 Jul 2015
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Differentiation of Innocent and Pathologic Murmurs in Pediatrics
- ClinicalTrials.gov ID
- NCT02512341
- Acronym / sponsor ID
- OTT01
- Conditions
- Heart Murmurs, Mitral Valve Prolapse, Systolic Murmurs
- Keywords
- Computer Aided Auscultation (CAA), Electronic Stethoscope, Phonocardiography, Heart Auscultation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- CSD Labs GmbHUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this preliminary clinical study is to assess the quality of a computational algorithm that automatically classifies murmurs of phonocardiograms (PCGs) as either pathologic (AHA class I) or as no- or innocent (AHA class III) in the pediatric population.
Each patient is auscultated and diagnosed independently by a medical specialist by means of a standard mechanical stethoscope. Additionally, for each patient, a PCG is recorded using a Littmann 3200 electronic stethoscope and later analyzed using the computational algorithm. An echocardiogram is performed as the gold-standard for determining heart pathologies. The results of the computer aided auscultation (CAA) are compared to the findings of the medical professionals as well as to the echocardiogram findings.
Hypothesis: The specific CAA algorithms used in this study are able to differentiate pathologic (AHA class I) from no- or innocent murmurs (AHA class III) in a pediatric population.
Detailed description
Background:
Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) would be of great value to the general practitioner and potentially also to the specialist. This would allow objective screening for structural heart disease, standardized documentation of auscultation findings, and may avoid unnecessary referrals to pediatric cardiologists. Our goal was to further develop and assess the quality of a novel computational algorithm that automatically classifies murmurs of phonocardiograms (PCGs) acquired in a pediatric population.
Methods:
Patients with no-, innocent-, and pathologic murmurs were recruited from the general pediatric cardiology clinic. Using an electronic stethoscope, PCGs were acquired by the pediatric cardiologist from each patient. The PCGs were analyzed by the algorithm and diagnoses were compared to findings by the pediatric specialist and echocardiography as the gold standard.
The following registry procedures and quality factors have been implemented in this preliminary clinical study:
- Quality assurance plan, including
- data validation
- proper registration procedures
- Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (medical records and paper case report forms).
- Standard Operating Procedures to address registry operations and analysis activities, including patient recruitment, data collection, data management, data analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Outpatients with and without heart defects showing pathological heart murmurs, innocent heart murmurs and heart sounds without murmurs at the cardiology department.
Key inclusion criteria (2 listed)
- outpatient
- parental approval for study participation
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer Aided Auscultation (CAA)Also: Phonocardiogram analysis, Automated heart murmur classification, Murmur screening | Device | – |
Primary outcome
Number of correctly diagnosed pathological heart murmurs through independent algorithm-based auscultation.
Time frame: 2 months
Each patient is screened and diagnosed regarding a potential heart murmur by a medical expert through standard stethoscope-based auscultation. Heart sounds are recorded using an electronic Littmann 3200 stethoscope. The resulting phonocardiograms are analyzed and diagnosed independently, offline, with no external input, by an algorithm. A final diagnosis for each patient is made by a medical expert by performing an echocardiogram, the gold standard method for heart murmur detection. The diagnoses of both the medical expert and the algorithm are finally compared to the echocardiogram-based diagnosis.
1 secondary outcome
Number of correctly diagnosed pathological heart murmurs through traditional stethoscope based auscultation by medical experts.
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lillian Lai, MD principal investigator
Children's Hospital of Eastern Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Murmurs and Mitral Valve Prolapse, run by CSD Labs GmbH at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of correctly diagnosed pathological heart murmurs through independent algorithm-based auscultation. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.