Carotid StenosisNCT01599195
Use of Amplified Sound Signal to Identify Presence of Carotid and Femoral Stenosis
An observational study of Carotid Stenosis and Femoral Arterial Stenosis, run by Albert Einstein Healthcare Network at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Carotid Stenosis, Femoral Arterial Stenosis, Carotid Bruit Asymptomatic
- What is being tested?
- AudioDoc
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- age 19-90 years
- having clinical ultrasound evaluation of carotid or femoral artery
Who cannot join
- under age 19; over age 90 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
About this study
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.
Read the 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.
- Being tested
- AudioDoc
- Keywords
- carotid stenosis, femoral artery ischemia, carotid bruit asymptomatic, carotid murmur
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AudioDocDevice
AudioDoc will be used to identify the carotid and femoral bruit
| Study group | Role | What they receive |
|---|---|---|
| adults | adults audiodoc use to evaluate for carotid or femoral bruit Receives: Device: AudioDoc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of bruit signal obtained from the amplified stethoscope(AudioDoc) to that found by conventional ultrasonography.
Measured: 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
Measured: duration of hospital stay, typically four days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startApr 2010
- Primary completionSep 2014
- Study completionJan 2017
Why it stopped: Enrollment did not progress as anticipated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Dissin, MD, Albert Einstein Healthcare Network
- Investigators
- Jonathan Dissin, MD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599195
- Sponsor's protocol ID
- HN 4209
- Status last verified
- Jan 2017
- First submitted
- 2 May 2012
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Amplified Sound Signal to Identify Presence of Carotid and Femoral Stenosis
- ClinicalTrials.gov ID
- NCT01599195
- Acronym / sponsor ID
- HN 4209
- Keywords
- carotid stenosis, femoral artery ischemia, carotid bruit asymptomatic, carotid murmur
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment did not progress as anticipated
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adults | – | Device: AudioDocadults audiodoc use to evaluate for carotid or femoral bruit |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- age 19-90 years
- having clinical ultrasound evaluation of carotid or femoral artery
Key exclusion criteria (1 listed)
- under age 19; over age 90 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AudioDocAudioDoc will be used to identify the carotid and femoral bruit | Device | adults |
Primary outcome
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.
1 secondary outcome
To assess the frequency spectral differences obtained from the different recording modalities
Time frame: duration of hospital stay, typically four days
Results and safety
The study was stopped early (reason given: Enrollment did not progress as anticipated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Dissin, MD principal investigator
Albert Einstein Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Stenosis and Femoral Arterial Stenosis, run by Albert Einstein Healthcare Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment did not progress as anticipated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.