Carotid Artery Stenting for Cognitive Impairment
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Diego
Disqualifiers: Under 18, MRI incompatibility, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the effectiveness of the treatment Carotid Artery Stenting for improving cognitive function?
Several studies have explored the impact of Carotid Artery Stenting (CAS) on cognitive function, with some indicating potential improvements in cognitive performance after the procedure. However, results are inconsistent, and factors like test design may influence outcomes, suggesting that while CAS might help some patients, its effects on cognition are not yet fully understood.
12345Is carotid artery stenting generally safe for humans?
Carotid artery stenting (CAS) is generally considered safe, with studies showing it as a viable alternative to surgery for treating narrowed carotid arteries, though it may have a risk of complications like stroke. Using cerebral protection devices during the procedure can reduce these risks, and many patients experience no major complications during follow-up.
678910How does carotid artery stenting differ from other treatments for cognitive impairment?
Carotid artery stenting (CAS) is unique because it involves placing a small mesh tube in the carotid artery to improve blood flow, which may help with cognitive function by enhancing brain perfusion. Unlike other treatments, CAS directly addresses blood flow issues that can affect brain function, and it is an alternative to surgery for patients with carotid artery stenosis.
1451112Eligibility Criteria
This trial is for adults over 18 with carotid artery disease, evidenced by significant narrowing of the carotid arteries. It's not suitable for those under 18, lacking capacity to consent, needing emergency stenting, incompatible with MRI scans or intolerant to normal blood pressure levels.Inclusion Criteria
My ultrasound shows I have significant narrowing in my carotid artery.
I am over 18 years old.
Exclusion Criteria
I need an urgent procedure for my carotid artery due to worsening symptoms.
I am younger than 18 years old.
I understand the risks and benefits of this study and can consent for myself.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-intervention Assessment
Cognitive testing and neuroimaging conducted at 2 months and 1 month before intervention
2 months
2 visits (in-person)
Intervention
Carotid artery stenting procedure
1 day
1 visit (in-person)
Post-intervention Assessment
Cognitive testing and neuroimaging conducted at 1 month and 2 months after intervention
2 months
2 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 months
Participant Groups
The study aims to understand how narrowed carotid arteries affect brain function. Participants will undergo neurocognitive tests and have their blood checked for inflammation markers before and after getting a procedure called Carotid Artery Stenting.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment3 Interventions
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.
Group II: Control GroupActive Control2 Interventions
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.
Carotid Artery Stenting is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Carotid Artery Stenting for:
- Symptomatic carotid stenosis ≥70%
- Asymptomatic carotid stenosis >60%
- Symptomatic carotid stenosis 50-69%
🇺🇸 Approved in United States as Carotid Artery Stenting for:
- Symptomatic carotid stenosis ≥70%
- Asymptomatic carotid stenosis >60%
- Symptomatic carotid stenosis 50-69%
🇨🇦 Approved in Canada as Carotid Artery Stenting for:
- Symptomatic carotid stenosis ≥70%
- Asymptomatic carotid stenosis >60%
- Symptomatic carotid stenosis 50-69%
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCSD Medical CenterSan Diego, CA
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Who Is Running the Clinical Trial?
University of California, San DiegoLead Sponsor
References
Effect of carotid artery stenting on cognitive function in patients with carotid artery stenosis: a prospective, 3-month-follow-up study. [2020]Carotid artery stenting (CAS) is emerging as an alternative to carotid endarterectomy for the treatment of carotid artery stenosis (CS), but the effect of CAS on the cognitive function of patients with severe CS has not been fully investigated. The aim of this study was to use comprehensive neuropsychological tests to determine the effect of CAS on cognitive function from baseline to 3 months postprocedure in patients with severe CS.
Ignoring floor and ceiling effects may underestimate the effect of carotid artery stenting on cognitive performance. [2018]Data on neuropsychological outcome after carotid artery stenting (CAS) remain inconsistent, furthermore cognitive outcome seems to be unpredictable in the individual case. Previous studies reporting improvement or decline might be due to ceiling and floor effects of the applied cognitive tests. We applied cognitive testing before and after CAS, avoiding the pitfall of ceiling and floor effects.
Neuropsychological sequelae of carotid angioplasty with stent placement: correlation with ischemic lesions in diffusion weighted imaging. [2022]Few studies investigated the neuropsychological outcome after carotid angioplasty with stent placement (CAS), yielding partially inconsistent results. The present investigation evaluated the effect of CAS in patients with high-grade stenosis and assessed the predictive value of ischemic lesion number for postinterventional cognitive deterioration.
The impact of carotid artery stenting on cognitive function in patients with extracranial carotid artery stenosis. [2015]The effect of carotid artery stenting (CAS) on cognitive function in patients with extracranial carotid artery stenosis is equivocal. The aim of this study was to examine the impact of CAS on various domains of cognitive function.
Carotid Artery Stenting and Its Impact on Cognitive Function: A Prospective Observational Study. [2020]Carotid artery stenting (CAS) has evolved as a first-line therapeutic option for carotid revascularization in indicated patients for stroke prevention, but there is still a lack of data on its effect on cognitive function (CF), especially among Indian patients. To determine the effect of CAS on CF and to study the immediate and delayed complications of CAS in Indian patients.
Octogenarians are not at increased risk for periprocedural stroke following carotid artery stenting. [2016]We analyzed the risk of adverse events following carotid angioplasty and stenting (CAS) in patients or = 80 years of age (group II).
Carotid Angioplasty and Stenting and Embolic Protection. [2018]We review the evidence on the safety and efficacy of carotid angioplasty and stenting (CAS) compared to carotid endarterectomy (CEA) and also summarizes emerging technical issues.
Outcomes of carotid artery stenting in high-risk patients with carotid artery stenosis: a single neurovascular center retrospective review of 101 consecutive patients. [2010]Carotid artery angioplasty and carotid artery stenting (CAS) offer a viable alternative to carotid endarterectomy for symptomatic and asymptomatic patients; however, the complication rates associated with CAS may be higher than previously documented. We evaluated the safety and efficacy of CAS in high surgical risk patients in a single neurovascular center retrospective review.
Siena carotid artery stenting score: a risk modelling study for individual patients. [2022]Carotid artery stenting (CAS) still entails a considerable peri-interventional risk of serious neurological adverse events. The aim of this study was to generate a score to grade this risk for CAS in individual patients.
[Carotid artery stenting with different cerebral protection systems]. [2010]Carotid angioplasty with stent implantation (CAS) has become an alternative for carotid endarterectomy in treatment of carotid arteries atherosclerosis due to low procedural injury and comparable procedural risk. Wide application of cerebral protection devices decreased the procedural risk. The aim of the study was to estimate the procedural safety of CAS procedures with application of different cerebral protection systems. CAS procedures were performed in 48 patients. One procedure was unsuccessful, in this patient stroke occurred. Distal occlusion balloon system was used in 5 patients, proximal occlusion balloons for common carotid artery was used in 21 pts and filter systems in 22 pts. During 6-months follow-up, we observed no death nor stroke (40 pts). In one patient we revealed TIA. Moreover we found restenosis in one patient 6 months after CAS (total occlusion). In our experience CAS procedures were safe and incidence of major cerebro-vascular complications comparable to other centers.
Improvement of Cerebral Glucose Metabolism in Symptomatic Patients With Carotid Artery Stenosis After Stenting. [2018]Neurocognitive performance among patients with carotid artery stenosis or occlusion may deteriorate because of chronic cerebral hypoperfusion. Carotid artery stenting (CAS) has been reported to improve cerebral perfusion and neurocognitive function. The purpose of the study was to evaluate cerebral metabolism using F-fluorodeoxyglucose (FDG) positron emission tomography (PET) after CAS.
Procedural embolic protection strategies for carotid artery stenting: current status and future prospects. [2023]Carotid artery angioplasty and stenting (CAS) is an established procedure to treat carotid artery stenosis for either primary or secondary prevention of stroke. Randomized clinical trials have shown an increased risk of periprocedural cerebrovascular events with CAS compared with carotid endarterectomy (CEA). Several strategies have been proposed to mitigate this risk, including alternative vascular access site, proximal/distal embolic protection devices, and dual-layer stents, among others.