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

Terminated

• Conditions: Carotid Stenosis; Carotid Bruit Asymptomatic; Carotid Murmur; Femoral Arterial Stenosis
• Interventions: Device: AudioDoc

• Registration Number: NCT01599195
• Lead Sponsor: Albert Einstein Healthcare Network

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2012-05-02
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-15
• Primary Completion: 2014-09
• Status Verified: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

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Exclusion Criteria

• under age 19; over age 90 years

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
adults	AudioDoc	adults audiodoc use to evaluate for carotid or femoral bruit

Primary Outcome Measures

Name	Time	Method
Comparison of bruit signal obtained from the amplified stethoscope(AudioDoc) to that found by conventional ultrasonography.	subjects will be followed for duration of hospital stay, typically four days.

Secondary Outcome Measures

Name	Time	Method
To assess the frequency spectral differences obtained from the different recording modalities	duration of hospital stay, typically four days

Trial Locations

Locations (1)

Albert Einstein Healthcare Network; 🇺🇸 Philadelphia, Pennsylvania, United States