Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Accuracy of an Artificially-intelligent Stethoscope

This study has been completed.
Sponsor:
Collaborators:
Thomas C. Dispenza, M.D.
John R. Bockoven, M.D. M.B.A.
Information provided by (Responsible Party):
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT00564122
First received: November 23, 2007
Last updated: October 31, 2011
Last verified: October 2011

November 23, 2007
October 31, 2011
December 2007
Not Provided
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 [ Time Frame: Not applicable; all data collection for any given patient will be completed within less than 12 hours--usually MUCH less than 12 hours. ] [ Designated as safety issue: No ]
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 [ Time Frame: Not applicable; all data collection for any given patient will be completed within less than 12 hours--usually MUCH less than 12 hours. ]
Complete list of historical versions of study NCT00564122 on ClinicalTrials.gov Archive Site
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. [ Time Frame: Not applicable; all data collection for any given patient will be completed within less than 12 hours--usually MUCH less than 12 hours. ] [ Designated as safety issue: No ]
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. [ Time Frame: Not applicable; all data collection for any given patient will be completed within less than 12 hours--usually MUCH less than 12 hours. ]
Not Provided
Not Provided
 
The Accuracy of an Artificially-intelligent Stethoscope
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
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Heart Murmurs
  • Congenital Heart Disease
  • Structural Heart Disease
  • Device: Artificially-Intelligent Stethoscope
    After subjects' medical visits are complete, the heart sounds of all subjects will be recorded and assessed by an artificially-intelligent stethoscope. Attempts will be made to make satisfactory 20-second recordings from a total of eight positions on the chest with the patient in supine and upright positions.
    Other Name: Cardioscan, Zargis Medical Corporation, Serial Number 000127
  • Other: Physical Examination
    A Pediatric Cardiologist will examine each subject to the extent needed to make clinical assessments. This represents the ordinary standard-of-care.
All subjects
Interventions:
  • Device: Artificially-Intelligent Stethoscope
  • Other: Physical Examination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
June 2008
Not Provided

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.
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00564122
070904
Yes
Akron Children's Hospital
Akron Children's Hospital
  • Thomas C. Dispenza, M.D.
  • John R. Bockoven, M.D. M.B.A.
Principal Investigator: Thomas C. Dispenza, M.D. Akron Children's Hospital
Principal Investigator: John R. Bockoven, M.D. M.B.A. Akron Children's Hospital
Akron Children's Hospital
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP