Carotid Artery DiseasesNCT03344276
Assessing Neurocognition After Cerebrovascular Intervention
A study testing Neurocognitive Assessments, Measurements of inflammatory biomarkers and Carotid Artery Stenting in people with Carotid Artery Diseases and Neurocognitive Dysfunction, run by University of California, San Diego at 1 site in United States.
Trial summary
Decreased blood flow to the brain can cause decreased cognitive function. Carotid disease can result in decreased blood flow to the brain. The investigators seek to assess this relationship prospectively through performing a battery of neurocognitive assessments, collection of serum markers of inflammation, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Diseases, Neurocognitive Dysfunction
- What is being tested?
- Neurocognitive Assessments, Measurements of inflammatory biomarkers and Carotid Artery Stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients >18 years of age
- ultrasound evidence of carotid stenosis; in which the patient has either 50% or greater symptomatic carotid stenosis or 70% or greater asymptomatic carotid stenosis.
Who cannot join
- patients <18 years of age
- patients with without compatibility for MRI
- patients requiring carotid stenting for reasons not related to long-standing stenosis
- patients requiring emergency carotid stenting for acute symptoms such as crescendo transient ischemic attacks, intolerance of physiologic blood pressure.
- Patients that do not have appropriate capacity (i.e. understand the risks and benefits associated with this study) or are unable to consent for themselves will not be included in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCSD Medical Center
San Diego, California, 92103
David R Santiago-Dieppa, MD, 6195435078, drsantiagodieppa@ucsd.edu
David R Santiago-Dieppa, MD
About this study
Decreased blood flow to the brain can cause decreased cognitive function. Carotid disease can result in decreased blood flow to the brain. The investigators seek to assess this relationship prospectively through performing a battery of neurocognitive assessments, collection of serum markers of inflammation, and through neuroimaging at two points before intervention (2 months and 1 month before stenting) and at two points after intervention (1 month and 2 months after intervention). The goal is to provide prospective evidence to identify the extent to which carotid stenosis and hypoperfusion of the brain results in diminished neurocognitive performance, and see if serum biomarkers before and after stenting correlate with these findings.
Read the detailed description
Patients are being asked to partake in this study because the PI has decided on clinical grounds as outlined in the clinical trial, NASCET, (either asymptomatic 70% carotid stenosis or symptomatic >50% carotid stenosis) that CAS or CEA is indicated. The only aspect of the study that is research is the cognitive testing, the inflammatory blood markers, and components of the neuroimaging.
In this pilot study 20 patients, undergoing CAS for CS, will undergo cognitive testing at 2 time points before intervention (1 months, and 2 months) and at 2 time points after invention (1 month and 2 months). The two preoperative time points will serve as the control group and the two postoperative time points will serve as the intervention group.
Patients, as outlined by NASCET criteria, will have between 50% symptomatic stenosis or 70% asymptomatic stenosis of the carotid artery. If patients present acutely or are otherwise clinically determined to be unstable (e.g. crescendo TIAs, intolerance of normal physiologic blood pressure, etc.) due to their carotid disease, they will excluded from the study.
Patients will serve as their own controls, classifying the study as a within-subjects design. Patients will also have venous blood drawn to ascertain the change in serum markers associated with endothelial dysfunction and inflammation before and after intervention. Finally, patients will have magnetic resonance imaging (MRA) one month before intervention and 2 months after intervention in order to assess changes in global cerebral blood flow.
The following neurocognitive tests will take place - the duration of all typically takes one hour to complete.
- Memory measured with the Hopkins Verbal Learning Test-Revised (HVLT-R) and Rey Complex Figure
- Executive function assessed with Trails A and B
- Attention/processing speed measured with Wechsler Adult Intelligence Scale Digit Span and Coding subtests
- Language assessed with the Multilingual Naming Test and Verbal Fluency
- Visuospatial abilities measured with Block Design
- Global cognition measured with Mattis Dementia Rating Scale
- Estimated premorbid intelligence measured with the American version of the National Adult Reading Test (preoperatively only)
- Mood assessed with the Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI) Biomarkers, as a proxy for systemic inflammation will also be collected. The following biomarkers are associated with inflammation-TNF-α, IL-6, IL-1β, CRP, IFN-γ and endothelial cell activation-sICAM sVCAM will be obtained from venous blood (5 ml) and stored at -80° C until the time of electrochemiluminescence assay. As an accompanying measurement of inflammation, complete blood counts will be assessed.
R statistical software will be used for the statistical analysis. Fisher exact, chi square, and logistic regression testing will be used to assess categorical data while paired t tests and linear regression models will be used to assess continuous variables. Multivariable univariate logistic and linear regression will be performed to assess if carotid intervention is associated with statistically significant changes in neurocognitive performance or changes in serum biomarker levels.
Additional predictors to assess neurocognitive performance will include age, gender, race, degree of carotid stenosis, side of stenosis, prior history of stroke, prior history of neurosurgical or endovascular interventions, presence of coronary artery disease, active malignancy, vasculopathy including diabetes, hypertension, hyperlipidemia, obesity, systemic vascular disease, intracranial atherosclerosis, ultrasound perfusion of intracranial vessels, prior neurocognitive decline: ie prior history of Alzheimer's, degenerative neurological disease. Outcome variables will include standardized neuropsychological measures. The investigators hypothesize a more exuberant neurocognitive response in patients with an incomplete circle of Willis.
A dropped model will be performed to prevent overfitting of the regression analysis. A p value less than 0.05 will be used to define statistical significance.
The investigators predict that patients will not have a statistically significant change in neurocognitive performance during the three-month and six-week time points prior to intervention-and this will serve as the control period. We predict that 35% of patients will have some improvement in neurocognition after intervention. The sample size calculator to identify a difference in groups at a p<0.05 with a power of 0.8 predicts with 5% attrition determines that 20 patients will be required for the analysis.
- Being tested
- Neurocognitive Assessments, Measurements of inflammatory biomarkers, Carotid Artery Stenting
- Keywords
- carotid stenosis, neurocognition, carotid stenting, circle of willis
- Medical subject headings
- Carotid Artery Diseases, Cognition Disorders, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive AssessmentsDiagnostic test
Patients will undergo carotid artery stenting for 50-70% carotid artery stenosis. Prior to surgery patients will undergo a battery of neurocogntive assessments 1 month and 2 months prior to surgery.
Measurements of inflammatory biomarkersDiagnostic test
Patients will undergo carotid artery stenting for 50-70% carotid artery stenosis. After surgery, patients will undergo blood draws to measure for inflammatory biomarkers.
Carotid Artery StentingProcedure or surgery
Patients will undergo carotid artery stenting for 50-70% carotid artery stenosis.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients, as outlined by NASCET criteria, will have between 50 symptomatic stenosis or 70% asymptomatic stenosis of the carotid artery. Patients, undergoing carotid artery stenting for carotid stenosis, will undergo cognitive testing at 2 time points before intervention (1 months, and 2 months). The two preoperative time points will serve as the control group. Receives: Diagnostic Test: Neurocognitive Assessments; Diagnostic Test: Measurements of inflammatory biomarkers |
| Intervention Group | Experimental | Patients, as outlined by NASCET criteria, will have between 50 symptomatic stenosis or 70% asymptomatic stenosis of the carotid artery. Patients, undergoing carotid artery stenting for carotid stenosis, will undergo cognitive testing at 2 time points after invention (1 month and 2 months). The two postoperative time points will serve as the intervention group. Receives: Diagnostic Test: Neurocognitive Assessments; Diagnostic Test: Measurements of inflammatory biomarkers; Procedure: Carotid Artery Stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognition
Neurocognition will be assessed through a battery of 8 tests to measure cognitive capacity across a range of neurocognitive domains.
Measured: 4 months
Secondary outcomes (7)
TNF-α
Inflammatory Markers: tumor necrosis factor-α
Measured: 4 months
IL-6
Inflammatory Markers: IL-6
Measured: 4 months
IL-1β
Inflammatory Markers: IL-1β
Measured: 4 months
CRP
Inflammatory Markers: CRP
Measured: 4 months
IFN-γ
Inflammatory Markers: IFN-γ
Measured: 4 months
sICAM-1
Inflammatory Markers: sICAM-1
Measured: 4 months
sVCAM-1
Inflammatory Markers: sVCAM-1
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start15 Jul 2021
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In this pilot study 20 patients, undergoing CAS for CS, will undergo cognitive testing at 2 time points before intervention (1 months, and 2 months) and at 2 time points after invention (1 month and 2 months). The two preoperative time points will serve as the control group and the two postoperative time points will serve as the intervention group. Patients will serve as their own controls, classifying the study as a within-subjects design. Patients will also have venous blood drawn to ascertain the change in serum markers associated with endothelial dysfunction and inflammation before and after intervention. Finally, patients will have magnetic resonance imaging (MRA) one month before intervention and 2 months after intervention in order to assess changes in global cerebral blood flow.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander A. Khalessi MD MS FAANS, University of California, San Diego
- Investigators
- Alexander A Khalessi, MD, Principal investigator, UC San DiegoDavid R Santiago-Dieppa, MD, Study director, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344276
- Sponsor's protocol ID
- 170103
- Status last verified
- Feb 2025
- First submitted
- 13 Nov 2017
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Per institutional review board, data will only be shared with the researchers specified on the research protocol.
Publications
Arntzen KA, Schirmer H, Johnsen SH, Wilsgaard T, Mathiesen EB. Carotid atherosclerosis predicts lower cognitive test results: a 7-year follow-up study of 4,371 stroke-free subjects - the Tromso study. Cerebrovasc Dis. 2012;33(2):159-65. doi: 10.1159/000334182. Epub 2012 Jan 5.
PubMed 22222422Baracchini C, Mazzalai F, Gruppo M, Lorenzetti R, Ermani M, Ballotta E. Carotid endarterectomy protects elderly patients from cognitive decline: a prospective study. Surgery. 2012 Jan;151(1):99-106. doi: 10.1016/j.surg.2011.06.031. Epub 2011 Sep 22.
PubMed 21943640Shapiro AM, Benedict RH, Schretlen D, Brandt J. Construct and concurrent validity of the Hopkins Verbal Learning Test-revised. Clin Neuropsychol. 1999 Aug;13(3):348-58. doi: 10.1076/clin.13.3.348.1749.
PubMed 10726605Blake GJ, Ridker PM. Novel clinical markers of vascular wall inflammation. Circ Res. 2001 Oct 26;89(9):763-71. doi: 10.1161/hh2101.099270.
PubMed 11679405Cheng Y, Wang YJ, Yan JC, Zhou R, Zhou HD. Effects of carotid artery stenting on cognitive function in patients with mild cognitive impairment and carotid stenosis. Exp Ther Med. 2013 Apr;5(4):1019-1024. doi: 10.3892/etm.2013.954. Epub 2013 Feb 8.
PubMed 23596467North American Symptomatic Carotid Endarterectomy Trial Collaborators; Barnett HJM, Taylor DW, Haynes RB, Sackett DL, Peerless SJ, Ferguson GG, Fox AJ, Rankin RN, Hachinski VC, Wiebers DO, Eliasziw M. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 1991 Aug 15;325(7):445-53. doi: 10.1056/NEJM199108153250701.
PubMed 1852179Wendell CR, Waldstein SR, Ferrucci L, O'Brien RJ, Strait JB, Zonderman AB. Carotid atherosclerosis and prospective risk of dementia. Stroke. 2012 Dec;43(12):3319-24. doi: 10.1161/STROKEAHA.112.672527. Epub 2012 Oct 25.
PubMed 23103489Sun Q, Xia Z, Qu C, Ruan X, Li J, Cong L, Zheng X, Du Y. Carotid artery stenting ameliorates the cognitive impairment in patients with leukoaraiosis, the ischemic change of cerebral white matter. Tohoku J Exp Med. 2014 Aug;233(4):257-64. doi: 10.1620/tjem.233.257.
PubMed 25098321
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Neurocognition After Cerebrovascular Intervention
- ClinicalTrials.gov ID
- NCT03344276
- Acronym / sponsor ID
- 170103
- Keywords
- carotid stenosis, neurocognition, carotid stenting, circle of willis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Nov 2017 (actual)
- 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.
Decreased blood flow to the brain can cause decreased cognitive function. Carotid disease can result in decreased blood flow to the brain. The investigators seek to assess this relationship prospectively through performing a battery of neurocognitive assessments, collection of serum markers of inflammation, and through neuroimaging at two points before intervention (2 months and 1 month before stenting) and at two points after intervention (1 month and 2 months after intervention). The goal is to provide prospective evidence to identify the extent to which carotid stenosis and hypoperfusion of the brain results in diminished neurocognitive performance, and see if serum biomarkers before and after stenting correlate with these findings.
Detailed description
Patients are being asked to partake in this study because the PI has decided on clinical grounds as outlined in the clinical trial, NASCET, (either asymptomatic 70% carotid stenosis or symptomatic >50% carotid stenosis) that CAS or CEA is indicated. The only aspect of the study that is research is the cognitive testing, the inflammatory blood markers, and components of the neuroimaging.
In this pilot study 20 patients, undergoing CAS for CS, will undergo cognitive testing at 2 time points before intervention (1 months, and 2 months) and at 2 time points after invention (1 month and 2 months). The two preoperative time points will serve as the control group and the two postoperative time points will serve as the intervention group.
Patients, as outlined by NASCET criteria, will have between 50% symptomatic stenosis or 70% asymptomatic stenosis of the carotid artery. If patients present acutely or are otherwise clinically determined to be unstable (e.g. crescendo TIAs, intolerance of normal physiologic blood pressure, etc.) due to their carotid disease, they will excluded from the study.
Patients will serve as their own controls, classifying the study as a within-subjects design. Patients will also have venous blood drawn to ascertain the change in serum markers associated with endothelial dysfunction and inflammation before and after intervention. Finally, patients will have magnetic resonance imaging (MRA) one month before intervention and 2 months after intervention in order to assess changes in global cerebral blood flow.
The following neurocognitive tests will take place - the duration of all typically takes one hour to complete.
- Memory measured with the Hopkins Verbal Learning Test-Revised (HVLT-R) and Rey Complex Figure
- Executive function assessed with Trails A and B
- Attention/processing speed measured with Wechsler Adult Intelligence Scale Digit Span and Coding subtests
- Language assessed with the Multilingual Naming Test and Verbal Fluency
- Visuospatial abilities measured with Block Design
- Global cognition measured with Mattis Dementia Rating Scale
- Estimated premorbid intelligence measured with the American version of the National Adult Reading Test (preoperatively only)
- Mood assessed with the Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI) Biomarkers, as a proxy for systemic inflammation will also be collected. The following biomarkers are associated with inflammation-TNF-α, IL-6, IL-1β, CRP, IFN-γ and endothelial cell activation-sICAM sVCAM will be obtained from venous blood (5 ml) and stored at -80° C until the time of electrochemiluminescence assay. As an accompanying measurement of inflammation, complete blood counts will be assessed.
R statistical software will be used for the statistical analysis. Fisher exact, chi square, and logistic regression testing will be used to assess categorical data while paired t tests and linear regression models will be used to assess continuous variables. Multivariable univariate logistic and linear regression will be performed to assess if carotid intervention is associated with statistically significant changes in neurocognitive performance or changes in serum biomarker levels.
Additional predictors to assess neurocognitive performance will include age, gender, race, degree of carotid stenosis, side of stenosis, prior history of stroke, prior history of neurosurgical or endovascular interventions, presence of coronary artery disease, active malignancy, vasculopathy including diabetes, hypertension, hyperlipidemia, obesity, systemic vascular disease, intracranial atherosclerosis, ultrasound perfusion of intracranial vessels, prior neurocognitive decline: ie prior history of Alzheimer's, degenerative neurological disease. Outcome variables will include standardized neuropsychological measures. The investigators hypothesize a more exuberant neurocognitive response in patients with an incomplete circle of Willis.
A dropped model will be performed to prevent overfitting of the regression analysis. A p value less than 0.05 will be used to define statistical significance.
The investigators predict that patients will not have a statistically significant change in neurocognitive performance during the three-month and six-week time points prior to intervention-and this will serve as the control period. We predict that 35% of patients will have some improvement in neurocognition after intervention. The sample size calculator to identify a difference in groups at a p<0.05 with a power of 0.8 predicts with 5% attrition determines that 20 patients will be required for the analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this pilot study 20 patients, undergoing CAS for CS, will undergo cognitive testing at 2 time points before intervention (1 months, and 2 months) and at 2 time points after invention (1 month and 2 months). The two preoperative time points will serve as the control group and the two postoperative time points will serve as the intervention group. Patients will serve as their own controls, classifying the study as a within-subjects design. Patients will also have venous blood drawn to ascertain the change in serum markers associated with endothelial dysfunction and inflammation before and after intervention. Finally, patients will have magnetic resonance imaging (MRA) one month before intervention and 2 months after intervention in order to assess changes in global cerebral blood flow.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Diagnostic Test: Neurocognitive Assessments, Diagnostic Test: Measurements of inflammatory biomarkersPatients, as outlined by NASCET criteria, will have between 50 symptomatic stenosis or 70% asymptomatic stenosis of the carotid artery. Patients, undergoing carotid artery stenting for carotid stenosis, will undergo cognitive testing at 2 time points before intervention (1 months, and 2 months). The two preoperative time points will serve as the control group. |
| Intervention Group | Experimental | Diagnostic Test: Neurocognitive Assessments, Diagnostic Test: Measurements of inflammatory biomarkers, Procedure: Carotid Artery StentingPatients, as outlined by NASCET criteria, will have between 50 symptomatic stenosis or 70% asymptomatic stenosis of the carotid artery. Patients, undergoing carotid artery stenting for carotid stenosis, will undergo cognitive testing at 2 time points after invention (1 month and 2 months). The two postoperative time points will serve as the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients >18 years of age
- ultrasound evidence of carotid stenosis; in which the patient has either 50% or greater symptomatic carotid stenosis or 70% or greater asymptomatic carotid stenosis.
Key exclusion criteria (5 listed)
- patients <18 years of age
- patients with without compatibility for MRI
- patients requiring carotid stenting for reasons not related to long-standing stenosis
- patients requiring emergency carotid stenting for acute symptoms such as crescendo transient ischemic attacks, intolerance of physiologic blood pressure.
- Patients that do not have appropriate capacity (i.e. understand the risks and benefits associated with this study) or are unable to consent for themselves will not be included in this study.
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 |
|---|---|---|
| Neurocognitive AssessmentsPatients will undergo carotid artery stenting for 50-70% carotid artery stenosis. Prior to surgery patients will undergo a battery of neurocogntive assessments 1 month and 2 months prior to surgery. | Diagnostic test | Control Group, Intervention Group |
| Measurements of inflammatory biomarkersPatients will undergo carotid artery stenting for 50-70% carotid artery stenosis. After surgery, patients will undergo blood draws to measure for inflammatory biomarkers. | Diagnostic test | Control Group, Intervention Group |
| Carotid Artery StentingPatients will undergo carotid artery stenting for 50-70% carotid artery stenosis. | Procedure or surgery | Intervention Group |
Primary outcome
Neurocognition
Time frame: 4 months
Neurocognition will be assessed through a battery of 8 tests to measure cognitive capacity across a range of neurocognitive domains.
7 secondary outcomes
TNF-α
Time frame: 4 months
IL-6
Time frame: 4 months
IL-1β
Time frame: 4 months
CRP
Time frame: 4 months
IFN-γ
Time frame: 4 months
sICAM-1
Time frame: 4 months
sVCAM-1
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 22222422Arntzen KA, Schirmer H, Johnsen SH, Wilsgaard T, Mathiesen EB. Carotid atherosclerosis predicts lower cognitive test results: a 7-year follow-up study of 4,371 stroke-free subjects - the Tromso study. Cerebrovasc Dis. 2012;33(2):159-65. doi: 10.1159/000334182. Epub 2012 Jan 5.
- Background: PubMed 21943640Baracchini C, Mazzalai F, Gruppo M, Lorenzetti R, Ermani M, Ballotta E. Carotid endarterectomy protects elderly patients from cognitive decline: a prospective study. Surgery. 2012 Jan;151(1):99-106. doi: 10.1016/j.surg.2011.06.031. Epub 2011 Sep 22.
- Background: PubMed 10726605Shapiro AM, Benedict RH, Schretlen D, Brandt J. Construct and concurrent validity of the Hopkins Verbal Learning Test-revised. Clin Neuropsychol. 1999 Aug;13(3):348-58. doi: 10.1076/clin.13.3.348.1749.
- Background: PubMed 11679405Blake GJ, Ridker PM. Novel clinical markers of vascular wall inflammation. Circ Res. 2001 Oct 26;89(9):763-71. doi: 10.1161/hh2101.099270.
- Background: PubMed 23596467Cheng Y, Wang YJ, Yan JC, Zhou R, Zhou HD. Effects of carotid artery stenting on cognitive function in patients with mild cognitive impairment and carotid stenosis. Exp Ther Med. 2013 Apr;5(4):1019-1024. doi: 10.3892/etm.2013.954. Epub 2013 Feb 8.
- Background: PubMed 1852179North American Symptomatic Carotid Endarterectomy Trial Collaborators; Barnett HJM, Taylor DW, Haynes RB, Sackett DL, Peerless SJ, Ferguson GG, Fox AJ, Rankin RN, Hachinski VC, Wiebers DO, Eliasziw M. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 1991 Aug 15;325(7):445-53. doi: 10.1056/NEJM199108153250701.
- Background: PubMed 23103489Wendell CR, Waldstein SR, Ferrucci L, O'Brien RJ, Strait JB, Zonderman AB. Carotid atherosclerosis and prospective risk of dementia. Stroke. 2012 Dec;43(12):3319-24. doi: 10.1161/STROKEAHA.112.672527. Epub 2012 Oct 25.
- Background: PubMed 25098321Sun Q, Xia Z, Qu C, Ruan X, Li J, Cong L, Zheng X, Du Y. Carotid artery stenting ameliorates the cognitive impairment in patients with leukoaraiosis, the ischemic change of cerebral white matter. Tohoku J Exp Med. 2014 Aug;233(4):257-64. doi: 10.1620/tjem.233.257.
- Individual participant dataSharing planned: No. Per institutional review board, data will only be shared with the researchers specified on the research protocol.
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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.
Alexander A Khalessi, MD principal investigator
UC San Diego
David R Santiago-Dieppa, MD study director
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurocognitive Assessments, Measurements of inflammatory biomarkers and Carotid Artery Stenting in people with Carotid Artery Diseases and Neurocognitive Dysfunction, run by University of California, San Diego 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 5 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: looking for participants now, as of the sponsor's last update on 6 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Khalessi, MD ((619) 543-5540, akhalessi@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognition (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03344276, which also lists 8 linked publications.
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 6 Feb 2025.