Heart MurmursNCT02105480
Automated Algorithm Based Analysis of Phonocardiograms of Newborns
An observational study of Heart Murmurs and Mitral Valve Prolapse, run by CSD Labs GmbH at 1 site in Austria.
Trial summary
The purpose of this double-blind pivotal clinical utility study is to determine on a large patient population whether heart murmurs can be reliably detected with high sensitivity and specificity using a locked, automated algorithm-based phonocardiogram analysis (also referred to as computer aided auscultation (CAA)). Read more about this study
- Who is it for?
- Ages 1 minute to 5 daysHealthy 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
- 220 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2013to 18 Jan 2017
- 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 minute to 5 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Premature babies and newborns stationed at the department of neonatology
Who may be able to join
- any premature baby or newborn
- 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 double-blind pivotal clinical utility study is to determine on a large patient population whether heart murmurs can be reliably detected with high sensitivity and specificity using a locked, automated algorithm-based phonocardiogram analysis (also referred to as computer aided auscultation (CAA)).
Each patient is auscultated and diagnosed independently by a medical specialist. Additionally, for each patient, an echocardiogram is performed as the gold-standard for determining heart pathologies. The CAA results are compared to the findings of the medical professionals as well as to the echocardiogram findings.
Hypothesis: The specific (locked) CAA algorithms used in this study are able to automatically diagnose pathological heart murmurs in premature babies and newborns with at least the same accuracy as experienced medical specialists.
Read the detailed description
The following registry procedures and quality factors have been implemented:
- Quality assurance plan, including
- data validation
- proper registration procedures
- regular site monitoring
- regular auditing
- Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
- 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, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
- Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
- Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.
- Plan for missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results.
- Conditions
- Heart Murmurs, Mitral Valve Prolapse, Systolic Murmurs
- Being tested
- Computer aided auscultation (CAA)
- Keywords
- Computer aided auscultation (CAA), Phonocardiogram analysis, Murmur detection, 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 heart murmurs through locked, independent algorithm based auscultation and 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 stethoscope and analyzed and diagnosed independently (with no external input) by a locked algorithm. A final diagnoses 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 (after completion of patient recruitment).
Measured: 2 years (expected)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startNov 2013
- Primary completion25 Jan 2016
- Study completion18 Jan 2017
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
- 220 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- CSD Labs GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerhard Pichler, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105480
- Sponsor's protocol ID
- GRZ02 (AAAPN)
- Status last verified
- Jul 2018
- First submitted
- 31 Mar 2014
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Algorithm Based Analysis of Phonocardiograms of Newborns
- ClinicalTrials.gov ID
- NCT02105480
- Acronym / sponsor ID
- GRZ02 (AAAPN)
- Conditions
- Heart Murmurs, Mitral Valve Prolapse, Systolic Murmurs
- Keywords
- Computer aided auscultation (CAA), Phonocardiogram analysis, Murmur detection, Heart auscultation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- CSD Labs GmbHUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- 25 Jan 2016 (actual)
- Study completion
- 18 Jan 2017 (actual)
- First posted
- 7 Apr 2014 (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 double-blind pivotal clinical utility study is to determine on a large patient population whether heart murmurs can be reliably detected with high sensitivity and specificity using a locked, automated algorithm-based phonocardiogram analysis (also referred to as computer aided auscultation (CAA)).
Each patient is auscultated and diagnosed independently by a medical specialist. Additionally, for each patient, an echocardiogram is performed as the gold-standard for determining heart pathologies. The CAA results are compared to the findings of the medical professionals as well as to the echocardiogram findings.
Hypothesis: The specific (locked) CAA algorithms used in this study are able to automatically diagnose pathological heart murmurs in premature babies and newborns with at least the same accuracy as experienced medical specialists.
Detailed description
The following registry procedures and quality factors have been implemented:
- Quality assurance plan, including
- data validation
- proper registration procedures
- regular site monitoring
- regular auditing
- Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
- 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, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
- Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
- Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.
- Plan for missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 1 minute to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Premature babies and newborns stationed at the department of neonatology
Key inclusion criteria (2 listed)
- any premature baby or newborn
- 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 heart murmurs through locked, independent algorithm based auscultation and traditional stethoscope based auscultation by medical experts
Time frame: 2 years (expected)
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 stethoscope and analyzed and diagnosed independently (with no external input) by a locked algorithm. A final diagnoses 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 (after completion of patient recruitment).
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 17 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.
Gerhard Pichler, MD principal investigator
Medical University of Graz
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 Austria.
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 17 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 Austria. 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 heart murmurs through locked, independent algorithm based auscultation and traditional stethoscope based auscultation by medical experts (time frame: 2 years (expected)). 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 17 Jul 2018.