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TerminatedNCT01599195Updated Feb 1, 2017

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

An observational study in Carotid Stenosis, Femoral Arterial Stenosis and Carotid Bruit Asymptomatic, sponsored by Albert Einstein Healthcare Network. Terminated at 1 site in United States. Open to participants aged 19 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-01.

Sponsored by Albert Einstein Healthcare Network · Observational

Why this study was terminated
Enrollment did not progress as anticipated
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
18
Ages
19 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Carotid Stenosis
  • Femoral Arterial Stenosis
  • Carotid Bruit Asymptomatic
  • Carotid Murmur

Keywords

  • carotid stenosis
  • femoral artery ischemia
  • carotid bruit asymptomatic
  • carotid murmur
03

In context

Carotid Stenosis

339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.

This study's enrollment of 18 is below the median of 173 across 144 observational studies indexed under Carotid Stenosis.

Browse Carotid Stenosis studies →

Lead sponsor

Albert Einstein Healthcare Network is the lead sponsor of 63 studies on the registry; 6 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

any person age 19 through 90 years who have been clinically determined to require evaluation of carotid or femoral arteries for suspected stenosis

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • under age 19; over age 90 years
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
18 participants (actual)

Groups and cohorts

  • adults

    adults audiodoc use to evaluate for carotid or femoral bruit

    Device: AudioDoc

Interventions

  • DeviceAudioDoc

    AudioDoc will be used to identify the carotid and femoral bruit

06

What researchers measure

Primary outcomes

  1. 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

  1. To assess the frequency spectral differences obtained from the different recording modalities

    Time frame: duration of hospital stay, typically four days

07

Study locations

1 site
  • Albert Einstein Healthcare Network
    Philadelphia, Pennsylvania 19141, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01599195
Lead sponsor
Albert Einstein Healthcare Network
Responsible party
Jonathan Dissin, MD (Principal Investigator, Albert Einstein Healthcare Network) — Principal investigator
First posted
May 15, 2012
Start date
Apr 2010
Primary completion
Sep 2014
Completion
Jan 2017
Last update
Feb 1, 2017

Study contacts

Jonathan Dissin, MD
principal investigator · Albert Einstein Healthcare Network

Oversight

Data monitoring committee
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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