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Completed

NCT Number: NCT02512341

Automatic Differentiation of Innocent and Pathologic Murmurs in Pediatrics

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Eastern Ontario

Ottawa, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • outpatient
  • parental approval for study participation

Exclusion criteria

  • none

Treatment and study plan

Computer Aided Auscultation (CAA)

Device

Other names: Phonocardiogram analysis, Automated heart murmur classification, Murmur screening

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of correctly diagnosed pathological heart murmurs through traditional stethoscope based auscultation by medical experts.

    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.

Sponsors and collaborators

Lead sponsor

CSD Labs GmbH

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jul 30, 2015
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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