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

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ClinicalTrials.gov Identifier: NCT01599195
Recruitment Status : Terminated (Enrollment did not progress as anticipated)
First Posted : May 15, 2012
Last Update Posted : February 1, 2017
Information provided by (Responsible Party):
Jonathan Dissin, MD, 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.

Condition or disease Intervention/treatment
Carotid Stenosis Femoral Arterial Stenosis Carotid Bruit Asymptomatic Carotid Murmur Device: AudioDoc

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
Actual Enrollment : 18 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of Amplified Sound Signal to Identify Presence of Carotid and Femoral Stenosis
Actual Study Start Date : April 2010
Primary Completion Date : September 2014
Study Completion Date : January 2017

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

Primary Outcome Measures :
  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 Outcome Measures :
  1. To assess the frequency spectral differences obtained from the different recording modalities [ Time Frame: duration of hospital stay, typically four days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • under age 19; over age 90 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599195

United States, Pennsylvania
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
Albert Einstein Healthcare Network
Principal Investigator: Jonathan Dissin, MD Albert Einstein Healthcare Network

Responsible Party: Jonathan Dissin, MD, Principal Investigator, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT01599195     History of Changes
Other Study ID Numbers: HN 4209
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jonathan Dissin, MD, Albert Einstein Healthcare Network:
carotid stenosis
femoral artery ischemia
carotid bruit asymptomatic
carotid murmur

Additional relevant MeSH terms:
Constriction, Pathologic
Carotid Stenosis
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases