Congenital Heart Disease Clinical Trial
Official title:
A Comparison of the Accuracy of an Artificially-Intelligent Stethoscope Versus Pediatric Cardiologists in the Assessment of Pediatric Patients Referred to a Cardiologist for the Assessment of a Heart Murmur
This study will characterize the accuracy of a commercially available artificially-intelligent stethoscope in determining which childhood murmurs suggest underlying congenital structural heart disease and therefore warrant diagnostic echocardiograms.
Heart murmurs can be ausculted in most pediatric patients, but underlying Congenital
Structural Heart (CSH) Disease is rare. Nevertheless, CSH Disease is often first suggested
by the presence of a murmur. Primary care providers refer pediatric patients to
Cardiologists for murmur evaluations with low accuracy, and this pattern results in:
1. needless emotional strain on many patients with functionally normal hearts and their
families,
2. increased morbidity and mortality rates for rare patients with delayed cardiac
diagnoses, and
3. exorbitant costs to society.
Referral accuracy for murmur evaluations probably is low because the differences between
innocent and pathological murmurs can be subtle. Computer-assisted analysis of heart sounds
may increase the accuracy of primary care referrals to pediatric cardiologists, but the
accuracy of the only FDA-approved artificially-intelligent cardiac auscultation system,
Zargis Medical Corporation's Cardioscan®, has never been determined prospectively in an
unselected population of live pediatric patients. As a primary endpoint, the study herein
proposed would prospectively compare the sensitivity and specificity of the Cardioscan® with
that of CHMCA's Pediatric Cardiologists in the identification of cardiac pathology among 300
new and unselected pediatric patients referred to CHMCA's cardiologists for murmur
evaluations, using two-dimensional transthoracic echocardiography as the common
gold-standard. Double-blinding will be in place. The study also will attempt secondarily to
gauge the clinical significance of pathology missed by the Cardioscan®, to define
sub-populations of patients among which the Cardioscan's® judgment should be considered less
accurate, and to gather data concerning the value and acceptability to families of the
Cardioscan®. If (as expected) the Cardioscan's® accuracy merely approaches that of Pediatric
Cardiologists, then the study herein proposed would still establish the Cardioscan® as a
formidable tool for primary care providers—a helpful, billable, and potentially cost-saving
alternative to consulting Cardiology on patients with probably- or possibly-innocent
murmurs. Data collection for this project will occur predominantly within CHMCA's Heart
Center in Akron, although some data collection may occur within CHMCA and/or at CHMCA's
Heart Centers in Beachwood and/or Boardman. Minimal disruption to existing clinical patient
flow through those settings would be expected and the entire protocol is expected to be
completely painless and noninvasive, with no foreseeable health risks.
;
Observational Model: Case-Crossover, Time Perspective: Prospective
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