Heart MurmursNCT03227848
eMurmur ID - Clinical Performance Evaluation
An observational study of Heart Murmurs and Pathologic Murmurs, run by CSD Labs GmbH at 1 site in Canada.
Trial summary
The differentiation between innocent and pathologic murmurs through traditional auscultation can often be challenging, which in the end makes the diagnosis strongly dependent on the clinitians experience and clinical expertise. Read more about this study
- Who is it for?
- Ages 1 day and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Murmurs, Pathologic Murmurs, Innocent Murmurs
- What is being tested?
- Automated Heart Murmur Detection AI
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jan 2017to 30 Apr 2018
- 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 1 day and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study participants will be chosen based on the heart murmur types required to meet a specified target patient population. Pre-selection of AHA class I and AHA class III patients will be done to achieve a reasonably similar distribution of murmur types compared to a US patient population. All major pathological and innocent murmur types will be included and their occurrence depending on age will be considered. Number of participants drawn: 120 participants across all ages will be included, 75% pediatric and 25% adult.
Who may be able to join
- All age groups of patients will be included from 1day old
- Patients who are being followed for known congenital heart disease and are returning for follow up
- Patients referred for a suspected heart murmur
Who cannot join
- Mismatch between the expert physician's diagnosis (auscultation based) and the diagnosis resulting from echocardiography (independently read by a cardiologist blinded to the auscultation results). Note: both, the expert physician and echocardiography results must independently reach the same diagnosis, which is then accepted as the gold standard reference diagnosis to which both devices are compared to. This is necessary because not every pathology visible on an echocardiogram causes an audible murmur, and not every murmur heard by a medical expert might correlate to pathology.
- Patient whose behaviour does not allow for a standard auscultation by the physician (e.g. a screaming fit).
Trial locations and contacts
1 site in 1 country.
About this study
The differentiation between innocent and pathologic murmurs through traditional auscultation can often be challenging, which in the end makes the diagnosis strongly dependent on the clinitians experience and clinical expertise. With the development of technology it is now possible to help diagnose heart murmurs using computer aided auscultation systems (CAA). eMurmur ID is an investigational CAA system (not FDA cleared) and the investigators hypothesize that it can distinguish between AHA class I (pathologic murmurs) and AHA class III heart sounds (innocent murmurs and/or no murmurs) with a sensitivity and specificity not worse compared to a similar FDA cleared CAA system on market.
- Conditions
- Heart Murmurs, Pathologic Murmurs, Innocent Murmurs, Congenital Heart Defect, Systolic Murmurs, Diastolic Murmurs
- Being tested
- Automated Heart Murmur Detection AI
- Medical subject headings
- Heart Murmurs, Heart Defects, Congenital, Systolic Murmurs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Heart Murmur Detection AIDevice
Also called eMurmur ID
Automated AI algorithm-based analysis of digital heart sound recordings to detect and classify heart murmurs. Heart sound recordings were fully blinded before undergoing one-time automated analysis. AI algorithm results for each recording include: AHA classification (Class I (pathologic heart murmur) versus class III (innocent heart murmur or no heart murmur), murmur timing, murmur grade, heart rate and S1/S2 identification.
What is being measured
The primary outcome is the main question the study is designed to answer.
eMurmur ID sensitivity and specificity
The primary endpoints of the study are sensitivity and specificity. The clinical reference gold standard diagnosis is defined as expert physicians' diagnosis confirmed by independently interpreted echocardiogram diagnosis.
True positive (TP), true negative (TN), false positive (FP) and false negative (FN) will be determined via comparison of the heart murmur classification results with the clinical gold standard (echocardiogram) diagnosis.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start4 Jan 2017
- Primary completion24 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 120 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 Hopsital of Eastern Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227848
- Sponsor's protocol ID
- OTT03
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lai LS, Redington AN, Reinisch AJ, Unterberger MJ, Schriefl AJ. Computerized Automatic Diagnosis of Innocent and Pathologic Murmurs in Pediatrics: A Pilot Study. Congenit Heart Dis. 2016 Sep;11(5):386-395. doi: 10.1111/chd.12328. Epub 2016 Mar 15.
PubMed 26990211
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
- eMurmur ID - Clinical Performance Evaluation
- ClinicalTrials.gov ID
- NCT03227848
- Acronym / sponsor ID
- OTT03
- Conditions
- Heart Murmurs, Pathologic Murmurs, Innocent Murmurs, Congenital Heart Defect, Systolic Murmurs, Diastolic Murmurs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- CSD Labs GmbHUniversity, hospital or other
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 24 Jul 2017 (actual)
- 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 differentiation between innocent and pathologic murmurs through traditional auscultation can often be challenging, which in the end makes the diagnosis strongly dependent on the clinitians experience and clinical expertise. With the development of technology it is now possible to help diagnose heart murmurs using computer aided auscultation systems (CAA). eMurmur ID is an investigational CAA system (not FDA cleared) and the investigators hypothesize that it can distinguish between AHA class I (pathologic murmurs) and AHA class III heart sounds (innocent murmurs and/or no murmurs) with a sensitivity and specificity not worse compared to a similar FDA cleared CAA system on market.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants will be chosen based on the heart murmur types required to meet a specified target patient population. Pre-selection of AHA class I and AHA class III patients will be done to achieve a reasonably similar distribution of murmur types compared to a US patient population. All major pathological and innocent murmur types will be included and their occurrence depending on age will be considered. Number of participants drawn: 120 participants across all ages will be included, 75% pediatric and 25% adult.
Key inclusion criteria (3 listed)
- All age groups of patients will be included from 1day old
- Patients who are being followed for known congenital heart disease and are returning for follow up
- Patients referred for a suspected heart murmur
Key exclusion criteria (2 listed)
- Mismatch between the expert physician's diagnosis (auscultation based) and the diagnosis resulting from echocardiography (independently read by a cardiologist blinded to the auscultation results). Note: both, the expert physician and echocardiography results must independently reach the same diagnosis, which is then accepted as the gold standard reference diagnosis to which both devices are compared to. This is necessary because not every pathology visible on an echocardiogram causes an audible murmur, and not every murmur heard by a medical expert might correlate to pathology.
- Patient whose behaviour does not allow for a standard auscultation by the physician (e.g. a screaming fit).
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 |
|---|---|---|
| Automated Heart Murmur Detection AIAlso: eMurmur IDAutomated AI algorithm-based analysis of digital heart sound recordings to detect and classify heart murmurs. Heart sound recordings were fully blinded before undergoing one-time automated analysis. AI algorithm results for each recording include: AHA classification (Class I (pathologic heart murmur) versus class III (innocent heart murmur or no heart murmur), murmur timing, murmur grade, heart rate and S1/S2 identification. | Device | – |
Primary outcome
eMurmur ID sensitivity and specificity
Time frame: 1 day
The primary endpoints of the study are sensitivity and specificity. The clinical reference gold standard diagnosis is defined as expert physicians' diagnosis confirmed by independently interpreted echocardiogram diagnosis. True positive (TP), true negative (TN), false positive (FP) and false negative (FN) will be determined via comparison of the heart murmur classification results with the clinical gold standard (echocardiogram) diagnosis.
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.
- Background: PubMed 26990211Lai LS, Redington AN, Reinisch AJ, Unterberger MJ, Schriefl AJ. Computerized Automatic Diagnosis of Innocent and Pathologic Murmurs in Pediatrics: A Pilot Study. Congenit Heart Dis. 2016 Sep;11(5):386-395. doi: 10.1111/chd.12328. Epub 2016 Mar 15.
- Computerized Automatic Diagnosis of Innocent and Pathologic Murmurs in Pediatrics: A Pilot Study.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Hopsital of Eastern Ontario, Canada
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 Pathologic Murmurs, 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 3 inclusion and 2 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?
eMurmur ID sensitivity and specificity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03227848, which also lists 1 linked publication.
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.