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

NCT01599195 | Terminated FDA Device

• 1 other identifier: HN 4209
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Stenosis; Femoral Arterial Stenosis; Carotid Bruit Asymptomatic; Carotid Murmur

Keywords

carotid stenosis; femoral artery ischemia; carotid bruit asymptomatic; carotid murmur

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To assess the frequency spectral differences obtained from the different recording modalities

  duration of hospital stay, typically four days

Study Arms (1)

adults

adults audiodoc use to evaluate for carotid or femoral bruit

Device: AudioDoc

Interventions

AudioDoc DEVICE

AudioDoc will be used to identify the carotid and femoral bruit

adults

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• under age 19; over age 90 years

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jonathan Dissin, MD

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 15, 2012
• Study Start: April 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: January 1, 2017
• Last Updated: February 1, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)