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

This study has been terminated.
(Enrollment did not progress as anticipated)
Sponsor:
Information provided by (Responsible Party):
Jonathan Dissin, MD, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier:
NCT01599195
First received: May 2, 2012
Last updated: January 31, 2017
Last verified: January 2017
  Purpose
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 Intervention
Carotid Stenosis
Femoral Arterial Stenosis
Carotid Bruit Asymptomatic
Carotid Murmur
Device: AudioDoc

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of Amplified Sound Signal to Identify Presence of Carotid and Femoral Stenosis

Further study details as provided by Albert Einstein Healthcare Network:

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

Enrollment: 18
Actual Study Start Date: April 2010
Study Completion Date: January 2017
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
adults
adults audiodoc use to evaluate for carotid or femoral bruit
Device: AudioDoc
AudioDoc will be used to identify the carotid and femoral bruit

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.
  Eligibility

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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • under age 19; over age 90 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599195

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

Responsible Party: Jonathan Dissin, MD, Principal Investigator, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT01599195     History of Changes
Other Study ID Numbers: HN 4209
Study First Received: May 2, 2012
Last Updated: January 31, 2017
Individual Participant Data  
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 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

ClinicalTrials.gov processed this record on March 30, 2017