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

• Sponsor: Albert Einstein Healthcare Network (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01599195
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Actual Duration (Months): 81.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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	Phase
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 Design

• 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: Apr 1, 2010
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. To assess the frequency spectral differences obtained from the different recording modalities [duration of hospital stay, typically four days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jonathan Dissin, MD, Principal Investigator, Albert Einstein Healthcare Network
• ClinicalTrials.gov Identifier: NCT01599195
• Other Study ID Numbers: HN 4209
• First Posted: May 15, 2012
• Last Update Posted: Feb 1, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Jonathan Dissin, MD, Principal Investigator, Albert Einstein Healthcare Network: carotid stenosis; femoral artery ischemia; carotid bruit asymptomatic; carotid murmur
• Additional relevant MeSH terms: Carotid Stenosis; Constriction, Pathologic

Study Results

No Results Posted as of Feb 1, 2017