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Neuroimaging Correlates of Memory Decline Following Carotid Interventions

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by Stanford University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Wei Zhou, Stanford University Identifier:
First received: October 29, 2012
Last updated: February 20, 2015
Last verified: February 2015
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.

Condition Intervention
Carotid Artery Stenosis
Other: Magnetic resonance imaging
Behavioral: Neuropsychological testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Brain MRI scans [ Time Frame: 6 months following the procedure ]
    White matter abnormality and perfusion in correlation with microembolization and cognitive change

Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Neuroimaging Correlates Other: Magnetic resonance imaging
arterial spin labeling, diffusion tensor imaging, and diffusion weighted imaging sequences will be used
Behavioral: Neuropsychological testing


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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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Please refer to this study by its identifier: NCT02006095

Contact: Wei Zhou, MD 650-493-5000 ext 67339

United States, California
Palo Alto Veterans Affairs Recruiting
Palo Alto, California, United States, 94304
Contact: Elizabeth Hitchner, MA    650-493-5000 ext 68632   
Principal Investigator: Wei Zhou, MD         
Sponsors and Collaborators
Stanford University
Principal Investigator: Wei Zhou, MD Palo Alto Veterans Affairs/Stanford University
  More Information

Responsible Party: Wei Zhou, Professor of Surgery, Stanford University Identifier: NCT02006095     History of Changes
Other Study ID Numbers: R21NS081416-01 ( US NIH Grant/Contract Award Number )
Study First Received: October 29, 2012
Last Updated: February 20, 2015

Keywords provided by Stanford University:
carotid artery stenting
carotid endarterectomy
magnetic resonance imaging (MRI)
neuropsychological testing

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on April 24, 2017