Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID03344276

Assessing Neurocognition After Cerebrovascular Intervention

Led by University of California, San Diego · Updated on 2025-02-06

20

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Decreased blood flow to the brain, caused by carotid artery disease, can lead to reduced cognitive function. Researchers are evaluating how carotid stenosis and brain hypoperfusion affect neurocognitive performance. This study also investigates whether inflammation markers in the blood relate to cognitive changes before and after carotid artery stenting. The research is designed as a pilot study involving 20 patients meeting specific carotid stenosis criteria. Participants will undergo carotid artery stenting and have neurocognitive testing at two time points before the procedure (2 months and 1 month prior) and two time points after the procedure (1 month and 2 months post-stenting). Blood samples will be collected before and after stenting to measure inflammatory biomarkers. Magnetic resonance angiography scans will be done one month before and two months after the intervention to assess cerebral blood flow changes. During the study, participants will complete various neurocognitive tests covering memory, executive function, attention, language, visuospatial abilities, global cognition, premorbid intelligence, and mood. Blood tests will measure markers linked to inflammation and endothelial activation. Researchers will analyze these data alongside clinical factors to understand cognitive changes related to carotid intervention. The total study participation includes pre- and post-intervention assessments over approximately four months.

CONDITIONS

Brief Title

Assessing Neurocognition After Cerebrovascular Intervention

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years of age or older
  • Ultrasound evidence of carotid stenosis with either 50% or greater symptomatic stenosis or 70% or greater asymptomatic stenosis
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years
  • Inability to undergo MRI
  • Need for carotid stenting for reasons other than long-standing stenosis
  • Emergency carotid stenting due to acute symptoms like crescendo transient ischemic attacks or blood pressure intolerance
  • Inability to understand the study risks and benefits or inability to provide consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 to 2 visits for eligibility assessment

Pre-intervention Assessments

Duration - 2 months

Participants undergo neurocognitive testing and biomarker blood draws at 2 time points before carotid artery stenting to serve as control measures.

2 visits (in-person) for assessments 1 and 2 months before intervention

Carotid Artery Stenting

Duration - 1 day

Participants undergo the carotid artery stenting procedure for carotid stenosis.

1 visit (in-person) for the stenting procedure

Post-intervention Assessments

Duration - 2 months

Participants undergo neurocognitive testing, biomarker blood draws, and neuroimaging at 1 and 2 months after carotid artery stenting to assess changes following intervention.

2 visits (in-person) for assessments 1 and 2 months after intervention

Trial Site Locations

Total: 1 location

1

UCSD Medical Center

San Diego, California, United States, 92103

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Research Team

A

Alexander Khalessi, MD

A

ARVIN WALI, BA, MAS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Carotid atherosclerosis predicts lower cognitive test results: a 7-year follow-up study of 4,371 stroke-free subjects - the Tromsø study.

Kjell Arne Arntzen, Henrik Schirmer, Stein Harald Johnsen...

https://pubmed.ncbi.nlm.nih.gov/22222422

Effects of carotid artery stenting on cognitive function in patients with mild cognitive impairment and carotid stenosis.

Yong Cheng, Yan Jiang Wang, Jia Chuan Yan...

https://pubmed.ncbi.nlm.nih.gov/23596467

Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis.

North American Symptomatic Carotid Endarterectomy Trial Collaborators, H J M Barnett, D W Taylor...

https://pubmed.ncbi.nlm.nih.gov/1852179

Carotid artery stenting ameliorates the cognitive impairment in patients with leukoaraiosis, the ischemic change of cerebral white matter.

QinJian Sun, ZhangYong Xia, ChuanQiang Qu...

https://pubmed.ncbi.nlm.nih.gov/25098321