<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/NCT03291340</url>
  </required_header>
  <id_info>
    <org_study_id>827852</org_study_id>
    <nct_id>NCT03291340</nct_id>
  </id_info>
  <brief_title>Determining the Impact of Shunting and CerebroVascular Reactivity on 7T MRI (DISCoVeR 7T MRI)</brief_title>
  <acronym>DISCoVeR</acronym>
  <official_title>A Pilot Cross-sectional Cohort Study of Right-to-left-shunt, Cerebrovascular Reactivity, Ischemic Infarct Burden on High Resolution MRI, and Cognitive Impairment in Elderly Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to use transcanial doppler (TCD) ultrasound to look for possible&#xD;
      risk factors for ischemic brain injury. We will perform contrast TCD with agitated saline&#xD;
      contrast to identify and contrast right-to-left shunt (RLS) and breath holding to assess&#xD;
      cerebrovascular reactivity (CVR) in the elderly.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Recruitment temporarily suspended due to COVID-19 pandemic.&#xD;
  </why_stopped>
  <start_date type="Actual">October 26, 2017</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</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>Presence of right-to-left shunt on TCD</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of cerebrovascular reactivity on TCD</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Volume of ischemic injury</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Location of ischemic injury</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of cognitive impairment</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of cognitive impairment</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Cognitively normal elderly</arm_group_label>
    <description>TCD agitated saline right-to-left shunt study TCD cerebrovascular reactivity study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive impaired elderly</arm_group_label>
    <description>TCD agitated saline right-to-left shunt study TCD cerebrovascular reactivity study</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Only subjects that are enrolled in the NACC longitudinal cohort (Protocol 068200) will be&#xD;
        eligible for this study. Subjects must also agree to participate in the ADCC&#xD;
        high-resolution MRI sub-study to be eligible.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females ≥ 60 years of age.&#xD;
&#xD;
          2. Fluent in English.&#xD;
&#xD;
          3. Part of the NACC longitudinal cohort (Protocol #: 068200) of the PMC/ADCC with&#xD;
             consensus conference designation of cognitively normal, Mild Cognitive Impairment, or&#xD;
             probable/possible Alzheimer's disease.&#xD;
&#xD;
          4. Has consented to participate in the ADCC high-resolution MRI sub-study.&#xD;
&#xD;
          5. NACC longitudinal visit must be within 6 months of the TCD study and brain MRI study.&#xD;
&#xD;
          6. Women: post-menopausal or surgically sterile.&#xD;
&#xD;
          7. Willing and able to complete all required study procedures.&#xD;
&#xD;
          8. Completed 6 grades of education.&#xD;
&#xD;
          9. Geriatric Depression scale less than 6 (assessed within 6 months at the NACC&#xD;
             longitudinal visit).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior clinically symptomatic ischemic or hemorrhagic stroke.&#xD;
&#xD;
          2. Inability to tolerate or contraindication to TCD study in the opinion of an&#xD;
             investigator or treating physician.&#xD;
&#xD;
          3. Any medical or psychological conditions that, in the opinion of the investigator,&#xD;
             would compromise the subject's safety or successful participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>November 23, 2022</last_update_submitted>
  <last_update_submitted_qc>November 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Steven Messe</investigator_full_name>
    <investigator_title>Associate Professor of Neurology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03291340
org study id: 827852
nct id: NCT03291340
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to use transcanial doppler (TCD) ultrasound to look for possible
      risk factors for ischemic brain injury. We will perform contrast TCD with agitated saline
      contrast to identify and contrast right-to-left shunt (RLS) and breath holding to assess
      cerebrovascular reactivity (CVR) in the elderly.
observational model: Cohort
time perspective: Prospective
measure: Presence of right-to-left shunt on TCD
time frame: Baseline
measure: Presence of cerebrovascular reactivity on TCD
time frame: Baseline
measure: Volume of ischemic injury
time frame: Baseline
measure: Location of ischemic injury
time frame: Baseline
measure: Presence of cognitive impairment
time frame: Baseline
measure: Type of cognitive impairment
time frame: Baseline
arm group label: Cognitively normal elderly
description: TCD agitated saline right-to-left shunt study TCD cerebrovascular reactivity study
arm group label: Cognitive impaired elderly
description: TCD agitated saline right-to-left shunt study TCD cerebrovascular reactivity study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Steven Messe
investigator title: Associate Professor of Neurology
mesh term: Cognitive Dysfunction
sharing ipd: No