<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01718600</url>
  </required_header>
  <id_info>
    <org_study_id>R01NS070308</org_study_id>
    <nct_id>NCT01718600</nct_id>
  </id_info>
  <brief_title>Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions</brief_title>
  <official_title>Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Microembolization is commonly associated with carotid artery stenting (CAS), but our&#xD;
      understanding of subclinical microembolization is superficial. Through collaborative effects&#xD;
      of multidisciplinary team-experts, novel approaches, and longitudinal evaluations, we hope to&#xD;
      better understand the clinical significance and long-term cognitive effects of microemboli.&#xD;
      This proposal may change our current clinical practice by providing a better outcome measure&#xD;
      for carotid interventions and improving outcomes of CAS procedures through risk factor&#xD;
      stratification. Our central hypothesis is that development of subclinical microemboli is&#xD;
      associated with decline in cognitive function following CAS and that the risk of development&#xD;
      of microemboli themselves is associated with patient- and procedure-related factors. We hope&#xD;
      that this prospective study will help to clarify these important issues in the era of rapidly&#xD;
      evolving percutaneous interventions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2011</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of microemboli in correlation with changes in neurocognitive assessment performance</measure>
    <time_frame>1 year following CAS procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factor stratification for incidence of microemboli</measure>
    <time_frame>1 year following CAS procedure</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">207</enrollment>
  <condition>Carotid Artery Stenosis</condition>
  <arm_group>
    <arm_group_label>Neuroimaging Correlates</arm_group_label>
    <description>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. 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 proposal, we hope to determine the risk factors and cognitive effect of microembolization following carotid revascularization procedures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Neuropsychological testing</intervention_name>
    <arm_group_label>Neuroimaging Correlates</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing carotid intervention&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is male or female &gt;40 yrs of age.&#xD;
&#xD;
          -  Patient has occlusive extracranial carotid stenosis (≥70%)&#xD;
&#xD;
          -  Patient is scheduled to undergo an endovascular intervention of a lesion in the&#xD;
             extracranial carotid artery&#xD;
&#xD;
          -  Patient agrees to voluntarily participate and signs an informed consent.&#xD;
&#xD;
          -  Patient agrees to be available for follow-up and is able to participate in all study&#xD;
             testing procedures.&#xD;
&#xD;
          -  Patient has sufficient visual and auditory acuity for cognitive testing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is unable to safely and comfortably undergo magnetic resonance imaging&#xD;
             procedures (e.g., claustrophobia, implanted medical devices that are MRI incompatible&#xD;
             such as pacemaker, defibrillator, neural stimulator etc)&#xD;
&#xD;
          -  Patient has an untreated or unsuccessfully controlled psychiatric disease&#xD;
             (schizophrenia, bipolar disorder).&#xD;
&#xD;
          -  Patient has prominent suicidal or homicidal ideation.&#xD;
&#xD;
          -  Patient has acute illness or unstable chronic illness (e.g. uncontrolled hypertension,&#xD;
             hepatic encephalopathy, portal hypertension, ascites, and esophageal varices,&#xD;
             pancreatitis).&#xD;
&#xD;
          -  Patient with a history of neurological (e.g., multiple sclerosis, seizure disorder,&#xD;
             Parkinson's disease) or systemic illness affecting central nervous system function.&#xD;
&#xD;
          -  Patient has prior closed head injury with ≥24 hours of amnesia.&#xD;
&#xD;
          -  Patient is unable to understand or sign the informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Palo Alto Veterans Affairs</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin, Madison</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Zhou W, Hitchner E, Gillis K, Sun L, Floyd R, Lane B, Rosen A. Prospective neurocognitive evaluation of patients undergoing carotid interventions. J Vasc Surg. 2012 Dec;56(6):1571-8. doi: 10.1016/j.jvs.2012.05.092. Epub 2012 Aug 11.</citation>
    <PMID>22889720</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>August 24, 2022</last_update_submitted>
  <last_update_submitted_qc>August 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>carotid artery stenting</keyword>
  <keyword>neuropsychological testing</keyword>
  <keyword>microembolization</keyword>
  <keyword>MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Stenosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01718600
org study id: R01NS070308
nct id: NCT01718600
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Microembolization is commonly associated with carotid artery stenting (CAS), but our
      understanding of subclinical microembolization is superficial. Through collaborative effects
      of multidisciplinary team-experts, novel approaches, and longitudinal evaluations, we hope to
      better understand the clinical significance and long-term cognitive effects of microemboli.
      This proposal may change our current clinical practice by providing a better outcome measure
      for carotid interventions and improving outcomes of CAS procedures through risk factor
      stratification. Our central hypothesis is that development of subclinical microemboli is
      associated with decline in cognitive function following CAS and that the risk of development
      of microemboli themselves is associated with patient- and procedure-related factors. We hope
      that this prospective study will help to clarify these important issues in the era of rapidly
      evolving percutaneous interventions.
observational model: Cohort
time perspective: Prospective
measure: Incidence of microemboli in correlation with changes in neurocognitive assessment performance
time frame: 1 year following CAS procedure
measure: Risk factor stratification for incidence of microemboli
time frame: 1 year following CAS procedure
arm group label: Neuroimaging Correlates
description: 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. 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 proposal, we hope to determine the risk factors and cognitive effect of microembolization following carotid revascularization procedures.
intervention type: Behavioral
intervention name: Neuropsychological testing
arm group label: Neuroimaging Correlates
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: United States
citation: Zhou W, Hitchner E, Gillis K, Sun L, Floyd R, Lane B, Rosen A. Prospective neurocognitive evaluation of patients undergoing carotid interventions. J Vasc Surg. 2012 Dec;56(6):1571-8. doi: 10.1016/j.jvs.2012.05.092. Epub 2012 Aug 11.
PMID: 22889720
responsible party type: Sponsor
mesh term: Carotid Stenosis