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Assessing Neurocognition After Cerebrovascular Intervention

ConditionsCarotid Artery DiseasesNeurocognitive Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 2 interventions
Group B: Intervention GroupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Neurocognition

Neurocognition will be assessed through a battery of 8 tests to measure cognitive capacity across a range of neurocognitive domains.

Time frame
4 months

Secondary outcomes

1

TNF-α

Inflammatory Markers: tumor necrosis factor-α

Time frame
4 months
2

IL-6

Inflammatory Markers: IL-6

Time frame
4 months
3

IL-1β

Inflammatory Markers: IL-1β

Time frame
4 months
4

CRP

Inflammatory Markers: CRP

Time frame
4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

Source ClinicalTrials.gov
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