Mitral Valve Prolapse Clinical Trial
Official title:
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.
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.
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