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
  Purpose

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.


Condition Intervention
Heart Murmurs
Congenital Heart Disease
Structural Heart Disease
Device: Artificially-Intelligent Stethoscope
Other: Physical Examination

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Akron Children's Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: December 2007
Study Completion Date: June 2008
Groups/Cohorts Assigned Interventions
All subjects 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.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564122

Locations
United States, Ohio
Akron Children's Hospital's Heart Center
Akron, Ohio, United States, 44308
Akron Children's Hospital's Heart Center
Beachwood, Ohio, United States, 44122
Akron Children's Hospital's Heart Center
Boardman, Ohio, United States, 44512
Sponsors and Collaborators
Akron Children's Hospital
Thomas C. Dispenza, M.D.
John R. Bockoven, M.D. M.B.A.
Investigators
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
  More Information

No publications provided

Responsible Party: Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT00564122     History of Changes
Other Study ID Numbers: 070904
Study First Received: November 23, 2007
Last Updated: October 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Akron Children's Hospital:
Murmur
Artificial-Intelligence
Stethoscope
Congenital Heart Disease
Structural Heart Disease

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Diseases
Heart Murmurs
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014