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Clinical Trials/NCT01599195
NCT01599195TerminatedNot Applicable

Use of Amplified Sound Signal to Identify Presence of Carotid and Femoral Stenosis

Albert Einstein Healthcare Network1 site in 1 country18 target enrollmentStarted: April 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
18
Locations
1
Primary Endpoint
Comparison of bruit signal obtained from the amplified stethoscope(AudioDoc) to that found by conventional ultrasonography.

Study Overview

Brief Summary

The purpose of the study is to test a new amplified stethoscope(AudioDoc) that can detect the presence of bruit by using an acoustic signal to represent the bruit. This pilot study will address two questions: is there a detectable difference in recorded sound signal of carotid and femoral bruit when compared to sound signals captured when there is no bruit present; is the use of a visual recorded signal more accurate in identifying carotid and femoral bruit when compared to traditional auscultation with a regular stethoscope and ultrasound.

Detailed Description

Recorded signals are stored on a laptop computer. The signals later undergo Fourier analysis are then compared to the findings on carotid ultrasoud as to degree of stenosis. Subjects with high grade stenosis in which no bruit was ascultated but in which carotid ultrasound data suggests a bruit may be present are studied for soft /inaudible bruits. When available, data will be correlated to CT/conventional angiographic studies.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
19 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • age 19-90 years
  • having clinical ultrasound evaluation of carotid or femoral artery

Exclusion Criteria

  • under age 19; over age 90 years

Outcomes

Primary Outcomes

Comparison of bruit signal obtained from the amplified stethoscope(AudioDoc) to that found by conventional ultrasonography.

Time Frame: subjects will be followed for duration of hospital stay, typically four days.

Secondary Outcomes

  • To assess the frequency spectral differences obtained from the different recording modalities(duration of hospital stay, typically four days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jonathan Dissin, MD

Principal Investigator

Albert Einstein Healthcare Network

Study Sites (1)

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