The Accuracy of an Artificially-intelligent Stethoscope

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564122
• Other study ID #: 070904
• Status: Completed
• Phase: N/A
• First received: November 23, 2007
• Last updated: October 31, 2011
• Start date: December 2007
• Est. completion date: June 2008

Study information

• Verified date: October 2011
• Source: Akron Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Heart Murmurs
• Structural Heart Disease

Intervention

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:
• Physical Examination
A Pediatric Cardiologist will examine each subject to the extent needed to make clinical assessments. This represents the ordinary standard-of-care.

Locations

Country	Name	City	State
United States	Akron Children's Hospital's Heart Center	Akron	Ohio
United States	Akron Children's Hospital's Heart Center	Beachwood	Ohio
United States	Akron Children's Hospital's Heart Center	Boardman	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Akron Children's Hospital	John R. Bockoven, M.D. M.B.A., Thomas C. Dispenza, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Not applicable; all data collection for any given patient will be completed within less than 12 hours--usually MUCH less than 12 hours.	No
Secondary	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.		Not applicable; all data collection for any given patient will be completed within less than 12 hours--usually MUCH less than 12 hours.	No