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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02512341
Other study ID # OTT01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2013
Est. completion date June 2014

Study information

Verified date July 2018
Source CSD Labs GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this preliminary clinical study is to assess the quality of a computational algorithm that automatically classifies murmurs of phonocardiograms (PCGs) as either pathologic (AHA class I) or as no- or innocent (AHA class III) in the pediatric population.

Each patient is auscultated and diagnosed independently by a medical specialist by means of a standard mechanical stethoscope. Additionally, for each patient, a PCG is recorded using a Littmann 3200 electronic stethoscope and later analyzed using the computational algorithm. An echocardiogram is performed as the gold-standard for determining heart pathologies. The results of the computer aided auscultation (CAA) are compared to the findings of the medical professionals as well as to the echocardiogram findings.

Hypothesis: The specific CAA algorithms used in this study are able to differentiate pathologic (AHA class I) from no- or innocent murmurs (AHA class III) in a pediatric population.


Description:

Background:

Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) would be of great value to the general practitioner and potentially also to the specialist. This would allow objective screening for structural heart disease, standardized documentation of auscultation findings, and may avoid unnecessary referrals to pediatric cardiologists. Our goal was to further develop and assess the quality of a novel computational algorithm that automatically classifies murmurs of phonocardiograms (PCGs) acquired in a pediatric population.

Methods:

Patients with no-, innocent-, and pathologic murmurs were recruited from the general pediatric cardiology clinic. Using an electronic stethoscope, PCGs were acquired by the pediatric cardiologist from each patient. The PCGs were analyzed by the algorithm and diagnoses were compared to findings by the pediatric specialist and echocardiography as the gold standard.

The following registry procedures and quality factors have been implemented in this preliminary clinical study:

- Quality assurance plan, including

- data validation

- proper registration procedures

- Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (medical records and paper case report forms).

- Standard Operating Procedures to address registry operations and analysis activities, including patient recruitment, data collection, data management, data analysis.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date June 2014
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- outpatient

- parental approval for study participation

Exclusion Criteria:

Study Design


Intervention

Device:
Computer Aided Auscultation (CAA)


Locations

Country Name City State
Canada Children's Hospital of Eastern Ontario Ottawa

Sponsors (1)

Lead Sponsor Collaborator
CSD Labs GmbH

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of correctly diagnosed pathological heart murmurs through independent algorithm-based auscultation. Each patient is screened and diagnosed regarding a potential heart murmur by a medical expert through standard stethoscope-based auscultation. Heart sounds are recorded using an electronic Littmann 3200 stethoscope. The resulting phonocardiograms are analyzed and diagnosed independently, offline, with no external input, by an algorithm. A final diagnosis for each patient is made by a medical expert by performing an echocardiogram, the gold standard method for heart murmur detection. The diagnoses of both the medical expert and the algorithm are finally compared to the echocardiogram-based diagnosis. 2 months
Secondary Number of correctly diagnosed pathological heart murmurs through traditional stethoscope based auscultation by medical experts. Each patient is screened and diagnosed regarding a potential heart murmur by a medical expert through standard stethoscope-based auscultation. Heart sounds are recorded using an electronic Littmann 3200 stethoscope. The resulting phonocardiograms are analyzed and diagnosed independently, offline, with no external input, by an algorithm. A final diagnosis for each patient is made by a medical expert by performing an echocardiogram, the gold standard method for heart murmur detection. The diagnoses of both the medical expert and the algorithm are finally compared to the echocardiogram-based diagnosis. 2 months
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