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OpenTrials
Completed

NCT Number: NCT02006095

Neuroimaging Correlates of Memory Decline Following Carotid Interventions

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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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Palo Alto Veterans Affairs

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Magnetic Resonance Imaging

Other

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

neuropsychological testing

Behavioral

Primary outcomes

  1. Brain MRI scans

    Time frame: 6 months following the procedure

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Dec 9, 2013
Registry last updated
Aug 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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