Carotid StenosisNCT00417586
Cost-Effectiveness of a Specialized Ultrasound Instrument to Diagnose Carotid Stenosis as a Way to Reduce the Risk of Stroke
An observational study of Carotid Stenosis and Cerebrovascular Accident, run by DVX, LLC at 1 site in United States.
Trial summary
Carotid stenosis, a condition in which plaque builds up inside the arteries of the neck and blocks blood flow to the brain, is one common cause of stroke. This study will evaluate the cost-effectiveness of using a new, specialized ultrasound device to screen individuals who are at risk for carotid stenosis. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carotid Stenosis, Cerebrovascular Accident
- What is being tested?
- Specialized Doppler Ultrasound Instrument
- Type of treatment
- Medical device
- How many people
- 984 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Nov 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Primary care patients who fit inclusion criteria
Who may be able to join
- At least one risk factor for carotid stenosis (e.g., cardiac disease, elevated cholesterol, smoking, hypertension)
Who cannot join
- Any symptoms or indications of carotid stenosis or stroke
Trial locations and contacts
1 site in 1 country.
United States1 site
Princeton Surgical Associates
Princeton, New Jersey, 08540
About this study
Official title: New Ultrasound Instrument for Carotid Screening
Carotid stenosis, a condition in which plaque builds up inside the arteries of the neck and blocks blood flow to the brain, is one common cause of stroke. This study will evaluate the cost-effectiveness of using a new, specialized ultrasound device to screen individuals who are at risk for carotid stenosis.
Read the detailed description
Stroke is the third leading cause of death, and the leading cause of long-term disability in the United States. At least half of all strokes are caused by carotid stenosis, a condition in which the arteries in the neck become blocked with plaque and harden. Plaque that breaks off the carotid artery wall and travels to the brain can block critical blood vessels, possibly resulting in a stroke. Carotid endarterectomy, a procedure that removes plaque buildup, can greatly reduce an individual's risk for stroke. Currently, the conventional duplex Doppler ultrasound examination that is used to screen for carotid stenosis requires a skilled sonographer or physician, and is therefore expensive. Study researchers have developed a more cost-effective option: a specialized ultrasound instrument specifically designed to perform carotid stenosis screenings and meant to be used by non-specialist nurses. Previous research has shown that this instrument is inexpensive, easy to use, and effective at diagnosing carotid stenosis. The purpose of this study is to evaluate the cost-effectiveness of the alternative ultrasound instrument at screening older adults who are at risk for carotid stenosis. If the instrument is shown to be cost-effective, it may eventually lead to widespread screening and a reduced incidence of stroke.
In this study, nurses in selected physician's offices will be trained to use the carotid ultrasound screening instrument. Patients over 65 years of age with at least one risk factor for carotid stenosis but with no symptoms will be screened with the device. Screening will take place in the doctors' offices or, when more convenient, at a central screening location; however, in all cases the nurses will use the instrument rather than specialized ultrasound technologists. Individuals found to have carotid stenosis will be referred to undergo a conventional duplex Doppler ultrasound examination for a definitive diagnosis.
- Conditions
- Carotid Stenosis, Cerebrovascular Accident
- Being tested
- Specialized Doppler Ultrasound Instrument
- Keywords
- Stroke
- Medical subject headings
- Carotid Stenosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized Doppler Ultrasound InstrumentDevice
Patients with a reading of 140 cm/sec or higher will be referred for further duplex screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2007 (estimated)
- Study startJun 2007
- Primary completionSep 2010
- Study completionNov 2010
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 984 participants (actual)
Sponsor and investigators
- Lead sponsor
- DVX, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, David Vilkomerson, DVX, LLC
- Investigators
- Kenneth Goldman, MD, Principal investigator, Princeton Surgical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417586
- Sponsor's protocol ID
- 468
- Other IDs
- R44HL072534, R44HL072534-02A1
- Status last verified
- Dec 2013
- First submitted
- 28 Dec 2006
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Ultrasound Instrument for Carotid Screening
- ClinicalTrials.gov ID
- NCT00417586
- Acronym / sponsor ID
- 468
- Conditions
- Carotid Stenosis, Cerebrovascular Accident
- Keywords
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 984 participants (actual)
- Lead sponsor
- DVX, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 1 Jan 2007 (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.
Carotid stenosis, a condition in which plaque builds up inside the arteries of the neck and blocks blood flow to the brain, is one common cause of stroke. This study will evaluate the cost-effectiveness of using a new, specialized ultrasound device to screen individuals who are at risk for carotid stenosis.
Detailed description
Stroke is the third leading cause of death, and the leading cause of long-term disability in the United States. At least half of all strokes are caused by carotid stenosis, a condition in which the arteries in the neck become blocked with plaque and harden. Plaque that breaks off the carotid artery wall and travels to the brain can block critical blood vessels, possibly resulting in a stroke. Carotid endarterectomy, a procedure that removes plaque buildup, can greatly reduce an individual's risk for stroke. Currently, the conventional duplex Doppler ultrasound examination that is used to screen for carotid stenosis requires a skilled sonographer or physician, and is therefore expensive. Study researchers have developed a more cost-effective option: a specialized ultrasound instrument specifically designed to perform carotid stenosis screenings and meant to be used by non-specialist nurses. Previous research has shown that this instrument is inexpensive, easy to use, and effective at diagnosing carotid stenosis. The purpose of this study is to evaluate the cost-effectiveness of the alternative ultrasound instrument at screening older adults who are at risk for carotid stenosis. If the instrument is shown to be cost-effective, it may eventually lead to widespread screening and a reduced incidence of stroke.
In this study, nurses in selected physician's offices will be trained to use the carotid ultrasound screening instrument. Patients over 65 years of age with at least one risk factor for carotid stenosis but with no symptoms will be screened with the device. Screening will take place in the doctors' offices or, when more convenient, at a central screening location; however, in all cases the nurses will use the instrument rather than specialized ultrasound technologists. Individuals found to have carotid stenosis will be referred to undergo a conventional duplex Doppler ultrasound examination for a definitive diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Primary care patients who fit inclusion criteria
Key inclusion criteria (1 listed)
- At least one risk factor for carotid stenosis (e.g., cardiac disease, elevated cholesterol, smoking, hypertension)
Key exclusion criteria (1 listed)
- Any symptoms or indications of carotid stenosis or stroke
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 |
|---|---|---|
| Specialized Doppler Ultrasound InstrumentPatients with a reading of 140 cm/sec or higher will be referred for further duplex screening | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
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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.
Kenneth Goldman, MD principal investigator
Princeton Surgical Associates
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 Cerebrovascular Accident, run by DVX, LLC 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 1 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: finished, as of the sponsor's last update on 11 Dec 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 11 Dec 2013.