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

Carotid Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01599195
• Other study ID #: HN 4209
• Status: Terminated
• Phase: N/A
• First received: May 2, 2012
• Last updated: January 31, 2017
• Start date: April 2010
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Albert Einstein Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: January 2017
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

Inclusion Criteria:

• age 19-90 years

• having clinical ultrasound evaluation of carotid or femoral artery

Exclusion Criteria:

• under age 19; over age 90 years

Related Conditions & MeSH terms

• Carotid Bruit Asymptomatic
• Carotid Murmur
• Carotid Stenosis
• Constriction, Pathologic
• Femoral Arterial Stenosis

Intervention

Device:
• AudioDoc
AudioDoc will be used to identify the carotid and femoral bruit

Locations

Country	Name	City	State
United States	Albert Einstein Healthcare Network	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess the frequency spectral differences obtained from the different recording modalities		duration of hospital stay, typically four days