Recruiting

Neurocognition

Sponsor:

UCLA

Code:

NCT03344276

Conditions

Carotid Artery Diseases

Neurocognitive Dysfunction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neurocognitive Assessments

Measurements of inflammatory biomarkers

Carotid Artery Stenting

Study Details

Brief 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 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.

Conditions

Carotid Artery Diseases

Neurocognitive Dysfunction

Study ID

NCT03344276

Start date

Jul 15, 2021

Status verified date

Feb, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

1. patients <18 years of age
2. patients with without compatibility for MRI
3. patients requiring carotid stenting for reasons not related to long-standing stenosis
4. patients requiring emergency carotid stenting for acute symptoms such as crescendo transient ischemic attacks, intolerance of physiologic blood pressure.
5. 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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Neurocognitive Assessments

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

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

Patients will undergo carotid artery stenting for 50-70% carotid artery stenosis.

Primary outcome measure

  • Neurocognition [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Alexander Khalessi, MD

(619) 543-5540akhalessi@ucsd.edu

ARVIN WALI, BA, MAS

7149282722AWALI@UCSD.EDU

Locations

UCSD Medical Center

Recruiting

San Diego, California, United States, 92103

Contacts

David R Santiago-Dieppa, MD

6195435078drsantiagodieppa@ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Feb 6, 2025

Last verified

Feb, 2025

Keywords

  • carotid stenosis
  • neurocognition
  • carotid stenting
  • circle of willis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-02-06.