An interventional study of Neurocognitive Assessments and Measurements of inflammatory biomarkers in Carotid Artery Diseases and Neurocognitive Dysfunction, sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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Among 77 studies in Carotid Artery Diseases with a site in United States — 15 open to participants now, 18 under way, none of them phase 3. Carotid Artery Diseases · United States.
Among the 77 studies in Carotid Artery Diseases with a site in United States, this one is the 37th largest by planned enrollment of the 43 interventional ones that give a count, is one of 3 that started in 2021, is one of 23 with no phase, reaches primary completion later than 5 of the 17 other live ones, and was the 53rd registered.
259 studies on the registry are indexed under Carotid Artery Diseases; 60 are open to participants now.
Browse Carotid Artery Diseases studies →15 of the 77 studies in Carotid Artery Diseases with a site in United States are open now. Recruiting first, the newest first:
Boston Scientific Corporation · Sites in United States
Ages 18+
Shockwave Medical, Inc. · Sites in United States
Ages 18+
University of California, San Francisco · Sites in United States
Ages 18+ · Women only
Intervascular · Sites in United States, Belgium, France and 1 more country
Ages 18+
Colorado Prevention Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 47 Carotid Artery Diseases studies recruiting now, 32 (68%) set no upper age limit and 2 (4%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
77 studies; the count open now beside each. This study's row is marked.
First in 1990; this study’s year is marked. 3 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 144 across 120 interventional studies indexed under Carotid Artery Diseases.
Median enrollment 210 across the 43 interventional studies, 211 across the 34 observational. Of the 51 that completed or were terminated, 22 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
35 of 77 have an industry lead sponsor. The 10 most frequent:
University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
University of California, San Diego has 1 study filed under Carotid Artery Diseases — fewer than ten, so there is no comparison to draw.
8 of the studies in Carotid Artery Diseases with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06653387InspireMDA Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach | 2026-11-20 |
| NCT02240862University of Maryland, BaltimoreThe CREST-2 Registry | 2026-12-31 |
| NCT02850588Society for Vascular Surgery Patient Safety OrganizationSVS VQI TransCarotid Revascularization Surveillance Project | 2026-12-31 |
| NCT07334834Colorado Prevention CenterImplementation of an Algorithm- and Multi-professional Team-supported Strategy to Improve Lipid Management of Patients With Atherosclerotic Cardiovascular Disease | 2027-05 |
| NCT07916883Washington University School of MedicinePET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite) | 2027-05-31 |
Add all 8 to your calendar (.ics) → With an account.
Among the 77 studies in Carotid Artery Diseases with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Neurocognitive Assessments · Diagnostic Test: Measurements of inflammatory biomarkers
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.
Diagnostic Test: Neurocognitive Assessments · Diagnostic Test: Measurements of inflammatory biomarkers · Procedure: Carotid Artery Stenting
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.
Patients will undergo carotid artery stenting for 50-70% carotid artery stenosis. After surgery, patients will undergo blood draws to measure for inflammatory biomarkers.
Patients will undergo carotid artery stenting for 50-70% carotid artery stenosis.
Neurocognition
Neurocognition will be assessed through a battery of 8 tests to measure cognitive capacity across a range of neurocognitive domains.
Time frame: 4 months
TNF-α
Inflammatory Markers: tumor necrosis factor-α
Time frame: 4 months
IL-6
Inflammatory Markers: IL-6
Time frame: 4 months
IL-1β
Inflammatory Markers: IL-1β
Time frame: 4 months
CRP
Inflammatory Markers: CRP
Time frame: 4 months
IFN-γ
Inflammatory Markers: IFN-γ
Time frame: 4 months
sICAM-1
Inflammatory Markers: sICAM-1
Time frame: 4 months
sVCAM-1
Inflammatory Markers: sVCAM-1
Time frame: 4 months
Plan to share: No — Per institutional review board, data will only be shared with the researchers specified on the research protocol.
Started Jul 2021 (actual). Primary completion is estimated for Oct 2025, 51 months after the start.
Of 42 interventional studies with no phase under Carotid Artery Diseases, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 59. This study's planned 51 months is above that.
How these figures are worked out, and which studies are left out of them.
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