Carotid Artery DiseaseNCT01042912
Frequency Analysis of Carotid Artery Disease
An observational study of Carotid Artery Disease, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to determine if carotid artery stenosis can be detected using an electronic stethoscope. This study will use a commercially available electronic stethoscope to record carotid sounds in patients with suspected carotid artery stenosis. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Carotid Artery Disease
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Feb 2010
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any inpatient or outpatient with inclusion criteria met and exclusion criteria not met presenting for aniography to the University of Minnesota Fairview Hospital or Clinic in Minneapolis or Redwing, Minnesota
Who may be able to join
- Age 40-80
- Indicated for diagnostic ultrasound related to carotid artery stenosis
Who cannot join
- Pregnant women
- Prior carotid intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center (UMMC) Fairview Clinics
Minneapolis, Minnesota, 55455
About this study
Official title: A Single-centered Investigation Into the Frequency Domain Patterns in the Carotid Vessel in Patients With Suspected Stenosis
The purpose of this study is to determine if carotid artery stenosis can be detected using an electronic stethoscope. This study will use a commercially available electronic stethoscope to record carotid sounds in patients with suspected carotid artery stenosis. The presence of absence of abnormal vessels will be confirmed by diagnostic ultrasound as part of normal patient care at this institution.
- Conditions
- Carotid Artery Disease
- Keywords
- diagnosis, carotid, artery, disease, auscultation, sound
- Medical subject headings
- Carotid Artery Diseases, Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startMay 2009
- Primary completionFeb 2010 (estimated)
- Study completionFeb 2010 (estimated)
Why it stopped: PI left inistitution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie A Johnson, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042912
- Sponsor's protocol ID
- 901M57884
- Status last verified
- Sep 2014
- First submitted
- 4 Jan 2010
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centered Investigation Into the Frequency Domain Patterns in the Carotid Vessel in Patients With Suspected Stenosis
- ClinicalTrials.gov ID
- NCT01042912
- Acronym / sponsor ID
- 901M57884
- Conditions
- Carotid Artery Disease
- Keywords
- diagnosis, carotid, artery, disease, auscultation, sound
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left inistitution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 6 Jan 2010 (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 this study is to determine if carotid artery stenosis can be detected using an electronic stethoscope. This study will use a commercially available electronic stethoscope to record carotid sounds in patients with suspected carotid artery stenosis. The presence of absence of abnormal vessels will be confirmed by diagnostic ultrasound as part of normal patient care at this institution.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any inpatient or outpatient with inclusion criteria met and exclusion criteria not met presenting for aniography to the University of Minnesota Fairview Hospital or Clinic in Minneapolis or Redwing, Minnesota
Key inclusion criteria (2 listed)
- Age 40-80
- Indicated for diagnostic ultrasound related to carotid artery stenosis
Key exclusion criteria (2 listed)
- Pregnant women
- Prior carotid intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
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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.
Marie A Johnson, PhD principal investigator
University of Minnesota
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 Artery Disease, run by University of Minnesota 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 2 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: withdrawn, as of the sponsor's last update on 19 Sep 2014. 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 withdrawn before enrolling participants, so there are no results.
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.
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 19 Sep 2014.