Use of Amplified Sound Signal to Identify Presence of Carotid and Femoral Stenosis
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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 |
- 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. ] [ Designated as safety issue: No ]
- To assess the frequency spectral differences obtained from the different recording modalities [ Time Frame: duration of hospital stay, typically four days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
adults
adults subjects clinically evaluated for carotid or femoral bruit
|
Device: AudioDoc
AudioDoc has the capability of recording sounds of blood flow in open or narrowed femoral or carotid arteries simply by placing head of stethoscope against selected vessel
|
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
any person age 19 through 90 years who have been clinically determined to require evaluation of carotid or femoral arteries for suspected stenosis
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| Contact: Jonathan Dissin, MD | 215-456-7190 | dissinj@einstein.edu |
| Contact: John Chukwunweike Nwosu | 215-456-3894 | johnchuk@einstein.edu |
| United States, Pennsylvania | |
| Albert Einstein Healthcare Network | Recruiting |
| Philadelphia, Pennsylvania, United States, 19141 | |
| Contact: Jonathan Dissin, MD 215-456-7190 dissinj@einstein.edu | |
| Contact: John Chukwunweike Nwosu 215-456-3894 johnchuk@einstein.edu | |
| Principal Investigator: Jonathan Dissin, MD | |
| Albert Einstein Healthcare Network | Recruiting |
| Philadelphia, Pennsylvania, United States, 19141 | |
| Contact: Jonathan Dissin, MD 215-456-7190 dissinj@einstein.edu | |
| Contact: John Chukwunweike Nwosu 215-456-3894 johnchuk@einstein.edu | |
| Principal Investigator: | Jonathan Dissin, MD | Albert Einstein Healthcare Network |
More Information
No publications provided
| Responsible Party: | Jonathan Dissin, MD, Director of Neurosensory Science Unit, 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: | May 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Albert Einstein Healthcare Network:
|
carotid stenosis femoral artery ischemia carotid bruit asymptomatic carotid murmur |
Additional relevant MeSH terms:
|
Carotid Stenosis Constriction, Pathologic Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 21, 2013