Cognitive Function in Carotid StentingNCT00919165
Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement
An observational study of Cognitive Function in Carotid Stenting, run by Corewell Health West at 1 site in United States.
Trial summary
To determine the effect of carotid artery stenting, on cognitive function, in patients with high grade carotid artery stenosis Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cognitive Function in Carotid Stenting
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to 20 Apr 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe carotid artery stenosis
Who may be able to join
- 40-80 years of age
- Right hand dominate
- Asymptomatic:defined as: no symptoms of TIA/stroke in the previous 6 months
- Baseline doppler study with a peak systolic velocity of 400cm/sec
- Patient is deemed candidate for carotid artery stenting
- TIMI flow of 1,2 or 3
Show all 9Show fewer
- 80% or greater stenosis of distal common or internal carotid artery, as determined angiographically, as defined in ACAS
- Subjects are able to give informed consent
- Subjects are willing/able to complete follow-up visits
Who cannot join
- History of major stroke: within the past 6 months
- History of Alzheimers disease or Dementia
- Unable or willing to complete the baseline and 20 days neuro-cognitive testing planned major surgery within the next 2 months
- Planned intervention opposite carotid artery within 2 months
- Ineligibility for carotid stent procedure due to anatomy, thrombus, or inability to complete anti-platelet therapy
- Any individual identified with cognitive impairment which would affect their performance during cognitive testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement: Cognitive Function in Carotid Stenting
To determine the effect of carotid artery stenting, on cognitive function, in patients with high grade carotid artery stenosis
Read the detailed description
Single Center, Case Controlled design using pre and post stent cognitive function testin. Patients will serve as self controls to observe the effect, if any, of carotid stent placement on cognitive function in asymptomatic patients with high grade carotid artery stenosis
- Conditions
- Cognitive Function in Carotid Stenting
- Keywords
- carotid stenting, cognitive function, pre and post stent, severe carotid artery 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.
| Study group | Role | What they receive |
|---|---|---|
| control and study group | severe carotid artery stenosis in asymptomatic patients defined as greater than 80% stenosis angiographically or greater than 400 cm/sec peak systolic velocity on carotid doppler evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the effect of carotid artery stenting, on cognitive function after carotid artery stenting in patients with severe carotid artery stenosis
Measured: 45 days
Secondary outcomes (1)
to evaluate the clinical benefit of carotid artery stenting on cognitive function, pre and post carotid artery stenting
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startDec 2007
- Primary completionMar 2017
- Study completion20 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Function in Carotid StentingStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Steven Pastyrnak, PhD, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919165
- Sponsor's protocol ID
- 2007-286
- Status last verified
- Jul 2023
- First submitted
- 11 Jun 2009
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement: Cognitive Function in Carotid Stenting
- ClinicalTrials.gov ID
- NCT00919165
- Acronym / sponsor ID
- 2007-286
- Conditions
- Cognitive Function in Carotid Stenting
- Keywords
- carotid stenting, cognitive function, pre and post stent, severe carotid artery stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Dec 2007
- Primary completion
- Mar 2017 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 12 Jun 2009 (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.
To determine the effect of carotid artery stenting, on cognitive function, in patients with high grade carotid artery stenosis
Detailed description
Single Center, Case Controlled design using pre and post stent cognitive function testin. Patients will serve as self controls to observe the effect, if any, of carotid stent placement on cognitive function in asymptomatic patients with high grade carotid artery stenosis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| control and study group | – | –severe carotid artery stenosis in asymptomatic patients defined as greater than 80% stenosis angiographically or greater than 400 cm/sec peak systolic velocity on carotid doppler evaluation |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe carotid artery stenosis
Key inclusion criteria (9 listed)
- 40-80 years of age
- Right hand dominate
- Asymptomatic:defined as: no symptoms of TIA/stroke in the previous 6 months
- Baseline doppler study with a peak systolic velocity of 400cm/sec
- Patient is deemed candidate for carotid artery stenting
Key exclusion criteria (6 listed)
- History of major stroke: within the past 6 months
- History of Alzheimers disease or Dementia
- Unable or willing to complete the baseline and 20 days neuro-cognitive testing planned major surgery within the next 2 months
- Planned intervention opposite carotid artery within 2 months
- Ineligibility for carotid stent procedure due to anatomy, thrombus, or inability to complete anti-platelet therapy
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
to determine the effect of carotid artery stenting, on cognitive function after carotid artery stenting in patients with severe carotid artery stenosis
Time frame: 45 days
1 secondary outcome
to evaluate the clinical benefit of carotid artery stenting on cognitive function, pre and post carotid artery stenting
Time frame: 45 days
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 13 Jul 2023.
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.
Steven Pastyrnak, PhD principal investigator
Corewell Health West
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 Cognitive Function in Carotid Stenting, run by Corewell Health West 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 9 inclusion and 6 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 13 Jul 2023. 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?
to determine the effect of carotid artery stenting, on cognitive function after carotid artery stenting in patients with severe carotid artery stenosis (time frame: 45 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 13 Jul 2023.