Carotid Artery StenosisNCT02006095
Neuroimaging Correlates of Memory Decline Following Carotid Interventions
An observational study of Carotid Artery Stenosis, run by Stanford University at 1 site in United States.
Trial summary
Carotid revascularization can significantly reduce the risk of stroke in patients with severe carotid stenosis; however, it has been associated with cognitive decline in 25% of the older adults who undergo the procedure. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Magnetic resonance imaging and Neuropsychological testing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Apr 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing carotid intervention
Who may be able to join
- Patient is male or female >40 yrs of age.
- Patient has occlusive extracranial carotid stenosis (≥70%)
- Patient is scheduled to undergo a carotid revascularization procedure
- Patient agrees to voluntarily participate in the study and signs an informed consent.
- Patient agrees to be available for follow-up and is able to participate in all study testing procedures.
- Patient has sufficient visual and auditory acuity for cognitive testing.
Who cannot join
- Patient is unable to safely and comfortably undergo MR imaging procedures (e.g., claustrophobia, implanted medical devices that are MRI incompatible such as pacemaker, defibrillator, neural stimulator etc)
- Patient has an untreated or unsuccessfully controlled psychiatric disease (schizophrenia, bipolar disorder).
- Patient has prominent suicidal or homicidal ideation.
- Patient has acute illness or unstable chronic illness (e.g. uncontrolled hypertension, hepatic encephalopathy, portal hypertension, ascites, and esophageal varices, pancreatitis).
- Patient with a history of neurological (e.g., multiple sclerosis, seizure disorder, Parkinson's disease) or systemic illness affecting central nervous system function.
- Patient has prior closed head injury with ≥24 hours of amnesia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Palo Alto Veterans Affairs
Palo Alto, California, 94304
About this study
Carotid revascularization can significantly reduce the risk of stroke in patients with severe carotid stenosis; however, it has been associated with cognitive decline in 25% of the older adults who undergo the procedure. Characterizing risk factors for cognitive decline following carotid interventions and individualizing treatment strategy based on those risks can minimize procedure-associated cognitive dysfunction. Neuroimaging techniques that characterize white matter integrity and regional hypoperfusion have the potential to provide sensitive brain structure indicators that may be associated with memory decline following revascularization procedures. In this protocol, we hope to determine how cerebral blood flow and baseline white matter abnormality in the vulnerable region modify the frequency and cognitive effect of microembolization following carotid revascularization procedures.
- Conditions
- Carotid Artery Stenosis
- Being tested
- Magnetic resonance imaging, Neuropsychological testing
- Keywords
- carotid artery stenting, carotid endarterectomy, magnetic resonance imaging (MRI), neuropsychological testing, microemboli
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingOther
arterial spin labeling, diffusion tensor imaging, and diffusion weighted imaging sequences will be used
Neuropsychological testingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Neuroimaging Correlates | Not described Receives: Other: Magnetic resonance imaging; Behavioral: Neuropsychological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain MRI scans
White matter abnormality and perfusion in correlation with microembolization and cognitive change
Measured: 6 months following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startNov 2012
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Zhou, MD, Principal investigator, Palo Alto Veterans Affairs/Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006095
- Sponsor's protocol ID
- R21NS081416-01
- Status last verified
- Aug 2022
- First submitted
- 29 Oct 2012
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Correlates of Memory Decline Following Carotid Interventions
- ClinicalTrials.gov ID
- NCT02006095
- Acronym / sponsor ID
- R21NS081416-01
- Conditions
- Carotid Artery Stenosis
- Keywords
- carotid artery stenting, carotid endarterectomy, magnetic resonance imaging (MRI), neuropsychological testing, microemboli
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 9 Dec 2013 (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 revascularization can significantly reduce the risk of stroke in patients with severe carotid stenosis; however, it has been associated with cognitive decline in 25% of the older adults who undergo the procedure. Characterizing risk factors for cognitive decline following carotid interventions and individualizing treatment strategy based on those risks can minimize procedure-associated cognitive dysfunction. Neuroimaging techniques that characterize white matter integrity and regional hypoperfusion have the potential to provide sensitive brain structure indicators that may be associated with memory decline following revascularization procedures. In this protocol, we hope to determine how cerebral blood flow and baseline white matter abnormality in the vulnerable region modify the frequency and cognitive effect of microembolization following carotid revascularization procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuroimaging Correlates | – | Other: Magnetic resonance imaging, Behavioral: Neuropsychological testing |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing carotid intervention
Key inclusion criteria (6 listed)
- Patient is male or female >40 yrs of age.
- Patient has occlusive extracranial carotid stenosis (≥70%)
- Patient is scheduled to undergo a carotid revascularization procedure
- Patient agrees to voluntarily participate in the study and signs an informed consent.
- Patient agrees to be available for follow-up and is able to participate in all study testing procedures.
Key exclusion criteria (6 listed)
- Patient is unable to safely and comfortably undergo MR imaging procedures (e.g., claustrophobia, implanted medical devices that are MRI incompatible such as pacemaker, defibrillator, neural stimulator etc)
- Patient has an untreated or unsuccessfully controlled psychiatric disease (schizophrenia, bipolar disorder).
- Patient has prominent suicidal or homicidal ideation.
- Patient has acute illness or unstable chronic illness (e.g. uncontrolled hypertension, hepatic encephalopathy, portal hypertension, ascites, and esophageal varices, pancreatitis).
- Patient with a history of neurological (e.g., multiple sclerosis, seizure disorder, Parkinson's disease) or systemic illness affecting central nervous system function.
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 |
|---|---|---|
| Magnetic resonance imagingarterial spin labeling, diffusion tensor imaging, and diffusion weighted imaging sequences will be used | Other | Neuroimaging Correlates |
| Neuropsychological testing | Behavioural | Neuroimaging Correlates |
Primary outcome
Brain MRI scans
Time frame: 6 months following the procedure
White matter abnormality and perfusion in correlation with microembolization and cognitive change
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 29 Aug 2022.
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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.
Wei Zhou, MD principal investigator
Palo Alto Veterans Affairs/Stanford University
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 Stenosis, run by Stanford University 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 6 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 29 Aug 2022. 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?
Brain MRI scans (time frame: 6 months following the procedure). 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 29 Aug 2022.