deltatrials
Completed OBSERVATIONAL NCT02512341

Automatic Differentiation of Innocent and Pathologic Murmurs in Pediatrics

Sponsor: CSD Labs GmbH

Updated 7 times since 2017 Last updated: Jul 16, 2018 Started: Nov 30, 2013 Primary completion: Dec 31, 2013 Completion: Jun 30, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Heart Murmurs and Mitral Valve Prolapse and is currently completed. CSD Labs GmbH leads this study, which shows 7 recorded versions since 2013 — indicating limited longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.

Study Description(click to expand)

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...

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.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotCompleted~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotCompleted~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshotCompleted~Aug 2018 – ~Jan 2021 · 29 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed

  2. Jul 2024 — Sep 2024 [monthly]

    Completed

  3. Jan 2021 — Jul 2024 [monthly]

    Completed

  4. Aug 2018 — Jan 2021 [monthly]

    Completed

  5. Jun 2018 — Aug 2018 [monthly]

    Completed

Show 2 earlier versions
  1. Apr 2018 — Jun 2018 [monthly]

    Completed

    Phase: NANone

  2. Jan 2017 — Apr 2018 [monthly]

    Completed NA

    First recorded

Nov 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • CSD Labs GmbH
Data source: CSD Labs GmbH

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations