Assessing Neurocognition After Cerebrovascular Intervention
Part of paid clinical trials in San Diego, California.
- Sponsor
- University of California, San Diego
- Study ID
- NCT03344276
- Status
- Recruiting
Conditions
- Carotid Artery Diseases
- Neurocognitive Dysfunction
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Neurocognitive Assessments — DIAGNOSTIC_TESTPatients 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 biomarkers — DIAGNOSTIC_TESTPatients 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 Stenting — PROCEDUREPatients will undergo carotid artery stenting for 50-70% carotid artery stenosis.
Study Details
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.
Key Dates
- Start date
- Jul 15, 2021
- Status verified
- Feb 2025
- Primary completion
- Oct 31, 2025
- Completion
- Dec 31, 2025
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Control GroupPatients, 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.
- Experimental: Intervention GroupPatients, 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.
Primary Outcome Measure
Neurocognition [ Time Frame: 4 months ]
Central Contacts
- Alexander Khalessi, MD(619) 543-5540
- ARVIN WALI, BA, MAS7149282722
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCSD Medical Center | San Diego | California | 92103 | David R Santiago-Dieppa, MD (SUB_INVESTIGATOR) |
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