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CompletedNCT02006095Updated Aug 29, 2022

Neuroimaging Correlates of Memory Decline Following Carotid Interventions

An observational study in Carotid Artery Stenosis, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-29.

Sponsored by Stanford University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
207
Ages
40 Years and older
Sex
All
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Study summary

Carotid revascularization can significantly reduce the risk of stroke in patients with severe carotid stenosis; however, it has been associated with cognitive decline in 25% of the older adults who undergo the procedure. Characterizing risk factors for cognitive decline following carotid interventions and individualizing treatment strategy based on those risks can minimize procedure-associated cognitive dysfunction. Neuroimaging techniques that characterize white matter integrity and regional hypoperfusion have the potential to provide sensitive brain structure indicators that may be associated with memory decline following revascularization procedures. In this protocol, we hope to determine how cerebral blood flow and baseline white matter abnormality in the vulnerable region modify the frequency and cognitive effect of microembolization following carotid revascularization procedures.

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Conditions studied

  • Carotid Artery Stenosis

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Keywords

  • carotid artery stenting
  • carotid endarterectomy
  • magnetic resonance imaging (MRI)
  • neuropsychological testing
  • microemboli
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In context

Carotid Stenosis

339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.

This study's enrollment of 207 is above the median of 173 across 144 observational studies indexed under Carotid Stenosis.

Browse Carotid Stenosis studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients undergoing carotid intervention

Inclusion criteria

  • Patient is male or female >40 yrs of age.
  • Patient has occlusive extracranial carotid stenosis (≥70%)
  • Patient is scheduled to undergo a carotid revascularization procedure
  • Patient agrees to voluntarily participate in the study and signs an informed consent.
  • Patient agrees to be available for follow-up and is able to participate in all study testing procedures.
  • Patient has sufficient visual and auditory acuity for cognitive testing.

Exclusion criteria

Exclusion Criteria:

  • Patient is unable to safely and comfortably undergo MR imaging procedures (e.g., claustrophobia, implanted medical devices that are MRI incompatible such as pacemaker, defibrillator, neural stimulator etc)
  • Patient has an untreated or unsuccessfully controlled psychiatric disease (schizophrenia, bipolar disorder).
  • Patient has prominent suicidal or homicidal ideation.
  • Patient has acute illness or unstable chronic illness (e.g. uncontrolled hypertension, hepatic encephalopathy, portal hypertension, ascites, and esophageal varices, pancreatitis).
  • Patient with a history of neurological (e.g., multiple sclerosis, seizure disorder, Parkinson's disease) or systemic illness affecting central nervous system function.
  • Patient has prior closed head injury with ≥24 hours of amnesia.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
207 participants (actual)
Patient registry
No

Groups and cohorts

  • Neuroimaging Correlates

    Other: Magnetic resonance imaging · Behavioral: Neuropsychological testing

Interventions

  • OtherMagnetic resonance imaging

    arterial spin labeling, diffusion tensor imaging, and diffusion weighted imaging sequences will be used

  • BehavioralNeuropsychological testing
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What researchers measure

Primary outcomes

  1. Brain MRI scans

    White matter abnormality and perfusion in correlation with microembolization and cognitive change

    Time frame: 6 months following the procedure

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Study locations

1 site
  • Palo Alto Veterans Affairs
    Palo Alto, California 94304, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02006095
Lead sponsor
Stanford University
Responsible party
Sponsor
First posted
Dec 9, 2013
Start date
Nov 2012
Primary completion
Apr 2018
Completion
Apr 2018
Last update
Aug 29, 2022

Study contacts

Wei Zhou, MD
principal investigator · Palo Alto Veterans Affairs/Stanford University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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