What this study is
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.
What's being tested
- Neurocognitive Assessments
Intervention · 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
Intervention · 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
Intervention · PROCEDURE
Patients will undergo carotid artery stenting for 50-70% carotid artery stenosis.
Study details
- Sponsor
- University of California, San Diego
- Conditions
- Carotid Artery Diseases · Neurocognitive Dysfunction
- Enrolling
- 20 people
- Starts
- 2021-07-15
- Est. completion
- 2025-12
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- Patients <18 years of age
- Patients with without compatibility for MRI
- Patients requiring carotid stenting for reasons not related to long-standing stenosis
- Patients requiring emergency carotid stenting for acute symptoms such as crescendo transient ischemic attacks, intolerance of physiologic blood pressure.
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUCSD Medical Center
San Diego, California, United States
- David R Santiago-Dieppa, MD · Contact6195435078drsantiagodieppa@ucsd.edu
- David R Santiago-Dieppa, MD · Sub-investigator
Recruiting
Study team
Sponsor
University of California, San Diego
Study ID 170103
Principal investigator
Alexander A Khalessi, MD
UC San Diego
Study director
David R Santiago-Dieppa, MD
UC San Diego
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.