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Neuroimaging Correlates of Memory Decline Following Carotid Interventions

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ClinicalTrials.gov Identifier: NCT02006095
Recruitment Status : Unknown
Verified February 2015 by Wei Zhou, Stanford University.
Recruitment status was:  Recruiting
First Posted : December 9, 2013
Last Update Posted : February 24, 2015
Sponsor:
Information provided by (Responsible Party):
Wei Zhou, Stanford University

Brief 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.

Condition or disease Intervention/treatment
Carotid Artery Stenosis Other: Magnetic resonance imaging Behavioral: Neuropsychological testing

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : November 2012
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Group/Cohort Intervention/treatment
Neuroimaging Correlates Other: Magnetic resonance imaging
arterial spin labeling, diffusion tensor imaging, and diffusion weighted imaging sequences will be used

Behavioral: Neuropsychological testing



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



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing carotid intervention
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Wei Zhou, Professor of Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT02006095     History of Changes
Other Study ID Numbers: R21NS081416-01 ( U.S. NIH Grant/Contract )
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015

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

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