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_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 biomarkers — DIAGNOSTIC_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 Stenting — PROCEDURE
    Patients 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 Group
    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.
  • Experimental: Intervention Group
    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.

Primary Outcome Measure

Neurocognition [ Time Frame: 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSD Medical CenterSan DiegoCalifornia92103
David R Santiago-Dieppa, MD
6195435078
David R Santiago-Dieppa, MD (SUB_INVESTIGATOR)

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