Clinical trial NCT00564122: The Accuracy of an Artificially-intelligent Stethoscope
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Murmurs
Congenital Heart Disease
Structural Heart Disease
Keywords: Murmur
Artificial-Intelligence
Stethoscope
Congenital Heart Disease
Structural Heart Disease
Lead sponsor: Akron Children's Hospital
Sponsor class: OTHER
Collaborators: name: Thomas C. Dispenza, M.D.
name: John R. Bockoven, M.D. M.B.A.
First posted: 2007-11-27
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient must present to a consulted Cardiologist for a 1st non-primary care murmur evaluation. This will usually occur in an outpatient Pediatric Cardiology clinic site.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* The patient must present to a consulted cardiologist for a 1st non-primary care murmur evaluation.

Exclusion Criteria:

* Non English-speakers
* At least moderately agitated or disruptive patients
* An echocardiogram or a Cardiology evaluation was done previously
* The patient no longer has an ausculable murmur at presentation.
* The patient didn't have a transthoracic echocardiogram with Color Doppler done.
* Patients admitted to the NICU before protocol completes.
* Protocol can't be completed on the day of presentation.

Primary outcomes:
measure: Sensitivity of the Artificially-Intelligent Stethoscope as compared with that of Pediatric Cardiologists in determining which patients needed echocardiograms because they have congenital structural heart disease
timeFrame: Not applicable; all data collection for any given patient will be completed within less than 12 hours--usually MUCH less than 12 hours.
Secondary outcomes:
measure: Specificity of the Artificially-Intelligent Stethoscope as compared with that of Pediatric Cardiologists in determining which patients needed echocardiograms because they have congenital structural heart disease.
timeFrame: Not applicable; all data collection for any given patient will be completed within less than 12 hours--usually MUCH less than 12 hours.
Other outcomes:
Locations:
city: Akron
country: United States
facility: Akron Children's Hospital's Heart Center
state: Ohio
city: Beachwood
country: United States
facility: Akron Children's Hospital's Heart Center
state: Ohio
city: Boardman
country: United States
facility: Akron Children's Hospital's Heart Center
state: Ohio
Study officials:
affiliation: Akron Children's Hospital
name: Thomas C. Dispenza, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Akron Children's Hospital
name: John R. Bockoven, M.D. M.B.A.
role: PRINCIPAL_INVESTIGATOR
References: