Carotid StenosisNCT01315288
A Randomized Trial of Clinical Decision Making in Asymptomatic Carotid Stenosis
A study testing One of 6 video presentation by one of 4 presenters in people with Carotid Stenosis, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this study is to determine patient variables, physician presenter variables, and information variables that might affect clinical decision making in asymptomatic carotid stenosis. The hypothesis is that information variables are the most significant determinant of clinical decision making. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- One of 6 video presentation by one of 4 presenters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Aug 2010
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No known history of carotid stenosis
Who cannot join
- History of dementia
- Unable to read English
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine patient variables, physician presenter variables, and information variables that might affect clinical decision making in asymptomatic carotid stenosis. The hypothesis is that information variables are the most significant determinant of clinical decision making.
- Conditions
- Carotid Stenosis
- Being tested
- One of 6 video presentation by one of 4 presenters
- Keywords
- Medical decision making, Asymptomatic Carotid Stenosis
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One of 6 video presentation by one of 4 presentersOther
| Study group | Role | What they receive |
|---|---|---|
| Video presentation absolute risk | Active comparator | absolute risk Receives: Other: One of 6 video presentation by one of 4 presenters |
| Video presentation absolute event-free survival | Active comparator | absolute event-free survival Receives: Other: One of 6 video presentation by one of 4 presenters |
| Video presentation annualized absolute risk | Active comparator | annualized absolute risk Receives: Other: One of 6 video presentation by one of 4 presenters |
| Video presentation relative risk | Active comparator | relative risk Receives: Other: One of 6 video presentation by one of 4 presenters |
| Video presentation qualitative description | Active comparator | qualitative description Receives: Other: One of 6 video presentation by one of 4 presenters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision regarding surgery
Subjects are asked to make a choice regarding surgery after watching a 30 second video.
Measured: Approximately 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startOct 2008
- Primary completionJan 2010
- Study completionAug 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.
- More trials run by Henry Ford Health SystemThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315288
- Sponsor's protocol ID
- ACSCDM-1
- Status last verified
- Jan 2024
- First submitted
- 14 Mar 2011
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Clinical Decision Making in Asymptomatic Carotid Stenosis
- ClinicalTrials.gov ID
- NCT01315288
- Acronym / sponsor ID
- ACSCDM-1
- Conditions
- Carotid Stenosis
- Keywords
- Medical decision making, Asymptomatic Carotid Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 15 Mar 2011 (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 patient variables, physician presenter variables, and information variables that might affect clinical decision making in asymptomatic carotid stenosis. The hypothesis is that information variables are the most significant determinant of clinical decision making.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Video presentation absolute risk | Active comparator | Other: One of 6 video presentation by one of 4 presentersabsolute risk |
| Video presentation absolute event-free survival | Active comparator | Other: One of 6 video presentation by one of 4 presentersabsolute event-free survival |
| Video presentation annualized absolute risk | Active comparator | Other: One of 6 video presentation by one of 4 presentersannualized absolute risk |
| Video presentation relative risk | Active comparator | Other: One of 6 video presentation by one of 4 presentersrelative risk |
| Video presentation qualitative description | Active comparator | Other: One of 6 video presentation by one of 4 presentersqualitative description |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No known history of carotid stenosis
Key exclusion criteria (2 listed)
- History of dementia
- Unable to read English
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 |
|---|---|---|
| One of 6 video presentation by one of 4 presenters | Other | Video presentation absolute event-free survival, Video presentation absolute risk, Video presentation annualized absolute risk, Video presentation qualitative description, Video presentation relative risk |
Primary outcome
Decision regarding surgery
Time frame: Approximately 2 minutes
Subjects are asked to make a choice regarding surgery after watching a 30 second video.
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 5 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One of 6 video presentation by one of 4 presenters in people with Carotid Stenosis, run by Henry Ford Health System 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 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: finished, as of the sponsor's last update on 5 Jan 2024. 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.
What does the primary outcome measure?
Decision regarding surgery (time frame: Approximately 2 minutes). 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 5 Jan 2024.