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

NCT ID: NCT01599195

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2017-01-31

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.

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

adults

adults audiodoc use to evaluate for carotid or femoral bruit

AudioDoc

Intervention Type: DEVICE

AudioDoc will be used to identify the carotid and femoral bruit

Interventions

AudioDoc

AudioDoc will be used to identify the carotid and femoral bruit

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Albert Einstein Healthcare Network

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Dissin, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Dissin, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein Healthcare Network

Locations

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

HN 4209

Identifier Type: -

Identifier Source: org_study_id