Clinical Trial: Automatic Differentiation of Innocent and Pathologic Murmurs in Pediatrics

Study Status: Completed
Recruit Status: Completed
Study Type: Observational [Patient Registry]

Official Title: Automatic Differentiation of Innocent and Pathologic Murmurs in Pediatrics

Brief Summary:

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.

Detailed Summary:

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 operation
  Sponsor: CSD Labs GmbH
  

  Current Primary Outcome: 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 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.
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome: 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 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.
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: CSD Labs GmbH
  

  Dates:
  Date Received: July 29, 2015
  Date Started: November 2013
  Date Completion:
  Last Updated: July 29, 2015
  Last Verified: July 2015