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Neuroimaging Correlates of Memory Decline Following Carotid Interventions

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Wei Zhou, Stanford University
ClinicalTrials.gov Identifier:
NCT02006095
First received: October 29, 2012
Last updated: November 17, 2014
Last verified: November 2014

October 29, 2012
November 17, 2014
November 2012
May 2015   (final data collection date for primary outcome measure)
Brain MRI scans [ Time Frame: 6 months following the procedure ] [ Designated as safety issue: No ]
White matter abnormality and perfusion in correlation with microembolization and cognitive change
Same as current
Complete list of historical versions of study NCT02006095 on ClinicalTrials.gov Archive Site
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Neuroimaging Correlates of Memory Decline Following Carotid Interventions
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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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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Carotid Artery Stenosis
  • Other: Magnetic resonance imaging
    arterial spin labeling, diffusion tensor imaging, and diffusion weighted imaging sequences will be used
  • Behavioral: Neuropsychological testing
Experimental: Neuroimaging Correlates
Interventions:
  • Other: Magnetic resonance imaging
  • Behavioral: Neuropsychological testing
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
May 2015
May 2015   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
Yes
Contact: Wei Zhou, MD 650-493-5000 ext 67339 weizhou@stanford.edu
United States
 
NCT02006095
R21NS081416-01
Yes
Wei Zhou, Stanford University
Stanford University
Not Provided
Principal Investigator: Wei Zhou, MD Palo Alto Veterans Affairs/Stanford University
Stanford University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP