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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
  Purpose

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: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

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 ] [ Designated as safety issue: No ]
    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)
Arms Assigned Interventions
Experimental: Neuroimaging Correlates Other: Magnetic resonance imaging
arterial spin labeling, diffusion tensor imaging, and diffusion weighted imaging sequences will be used
Behavioral: Neuropsychological testing

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02006095

Contacts
Contact: Wei Zhou, MD 650-493-5000 ext 67339 weizhou@stanford.edu

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

No publications provided

Responsible Party: Wei Zhou, Professor of Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT02006095     History of Changes
Other Study ID Numbers: R21NS081416-01
Study First Received: October 29, 2012
Last Updated: November 17, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Carotid Stenosis
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014