xml: <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/NCT06018090</url>
    </required_header>
    <id_info>
      <org_study_id>362/19</org_study_id>
      <nct_id>NCT06018090</nct_id>
    </id_info>
    <brief_title>Microembolic Detection in Acute Ischemic Stroke Patients With Atrial Fibrillation and Outcome</brief_title>
    <official_title>Microembolic Detection in Acute Ischemic Stroke Patients With Atrial Fibrillation and Outcome - A Prospective Multicenter Study With Transcranial Doppler</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centro Hospitalar De São João, E.P.E.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Giessen</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Padova</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Ostrava</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Clinical Hospital Centre Zagreb</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Centro Hospitalar De São João, E.P.E.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This multicenter international prospective cohort study will include patients with AIS with a&#xD;
        known or newly diagnosed anticoagulant-naïve AF. All centers will use the same transcranial&#xD;
        Doppler machine for one-hour monitoring with bilateral 2-MHz probes within 24 hours of&#xD;
        symptom onset. Recordings will be analyzed for MES by a blinded central reader. The primary&#xD;
        aim is to determine the proportion of patients with MES and the association of MES with&#xD;
        functional outcomes assessed by a modified Rankin scale (mRS) score at 90 days.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 6, 2019</start_date>
    <completion_date type="Actual">October 6, 2022</completion_date>
    <primary_completion_date type="Actual">August 31, 2022</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>90 Days</target_duration>
    <primary_outcome>
      <measure>Prevalence of MES</measure>
      <time_frame>Within 24 hours of symptom onset</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Poor functional outcome</measure>
      <time_frame>90-days after stroke</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Ordinal Shift Analysis of mRS scale score</measure>
      <time_frame>90-days after stroke</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">61</enrollment>
    <condition>Infarction, Brain</condition>
    <condition>Embolism</condition>
    <condition>Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>Acute Ischemic Stroke Patients with Atrial Fibrillation</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>The presence and rate of MES measured by TCD monitoring</intervention_name>
      <description>TCD monitoring within 24 hours from the last known well time. Bilateral M1 segments of middle cerebral artery were insonated at a single depth with 2-MHz transducers secured by a probe-holder.</description>
      <arm_group_label>Acute Ischemic Stroke Patients with Atrial Fibrillation</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Acute ischemic stroke admitted to the Stroke Unit, history of AF/flutter, or a new&#xD;
          diagnosis of AF at the time of stroke, and able possibility to be monitored within 24 hours&#xD;
          after symptom onset.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  acute ischemic stroke admitted to the Stroke Unit, history of AF/flutter or a new&#xD;
               diagnosis of AF at the stroke, and with a possibility to be monitored within 24 hours&#xD;
               after symptom onset.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  use of anticoagulants at stroke onset; prosthetic valves; inadequate temporal bone&#xD;
               window; uncooperative patients.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Pedro Miguel Castro</name>
        <address>
          <city>Porto</city>
          <zip>4200-319</zip>
          <country>Portugal</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Portugal</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Centro Hospitalar De São João, E.P.E.</investigator_affiliation>
      <investigator_full_name>Pedro Castro</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Infarction</keyword>
    <keyword>Embolism</keyword>
    <keyword>Atrial Fibrillation</keyword>
    <keyword>Ultrasound</keyword>
    <keyword>Transcranial Doppler</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ischemic Stroke</mesh_term>
      <mesh_term>Brain Infarction</mesh_term>
      <mesh_term>Atrial Fibrillation</mesh_term>
      <mesh_term>Embolism</mesh_term>
      <mesh_term>Infarction</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06018090
  org study id: 362/19
  nct id: NCT06018090
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This multicenter international prospective cohort study will include patients with AIS with a
        known or newly diagnosed anticoagulant-naïve AF. All centers will use the same transcranial
        Doppler machine for one-hour monitoring with bilateral 2-MHz probes within 24 hours of
        symptom onset. Recordings will be analyzed for MES by a blinded central reader. The primary
        aim is to determine the proportion of patients with MES and the association of MES with
        functional outcomes assessed by a modified Rankin scale (mRS) score at 90 days.
  observational model: Cohort
  time perspective: Prospective
  measure: Prevalence of MES
  time frame: Within 24 hours of symptom onset
  measure: Poor functional outcome
  time frame: 90-days after stroke
  measure: Ordinal Shift Analysis of mRS scale score
  time frame: 90-days after stroke
  arm group label: Acute Ischemic Stroke Patients with Atrial Fibrillation
  intervention type: Other
  intervention name: The presence and rate of MES measured by TCD monitoring
  description: TCD monitoring within 24 hours from the last known well time. Bilateral M1 segments of middle cerebral artery were insonated at a single depth with 2-MHz transducers secured by a probe-holder.
  arm group label: Acute Ischemic Stroke Patients with Atrial Fibrillation
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Portugal
  responsible party type: Principal Investigator
  investigator affiliation: Centro Hospitalar De São João, E.P.E.
  investigator full name: Pedro Castro
  investigator title: Professor
  mesh term: Ischemic Stroke
  mesh term: Brain Infarction
  mesh term: Atrial Fibrillation
  mesh term: Embolism
  mesh term: Infarction