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

January 31, 2017 updated by: Jonathan Dissin, MD, Albert Einstein Healthcare Network
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Healthcare Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • under age 19; over age 90 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
adults
adults audiodoc use to evaluate for carotid or femoral bruit
Device: AudioDoc
AudioDoc will be used to identify the carotid and femoral bruit

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the frequency spectral differences obtained from the different recording modalities
Time Frame: duration of hospital stay, typically four days
duration of hospital stay, typically four days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein Healthcare Network

Investigators

  • Principal Investigator: Jonathan Dissin, MD, Albert Einstein Healthcare Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2010

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

May 2, 2012

First Submitted That Met QC Criteria

May 14, 2012

First Posted (Estimate)

May 15, 2012

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN 4209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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