<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/NCT04455529</url>
  </required_header>
  <id_info>
    <org_study_id>PUTH2016144</org_study_id>
    <nct_id>NCT04455529</nct_id>
  </id_info>
  <brief_title>Current Situation of Natural History, Diagnosis and Treatment in Inpatients With Embolism Stroke of Unknown Cause (ESUS)</brief_title>
  <official_title>A Research of Current Situation of Natural History, Diagnosis and Treatment in Inpatients With Embolism Stroke of Unknown Cause (ESUS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</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>
      Evaluate the epidemiological characteristics, risk factors, clinical characteristics in&#xD;
      patients with ESUS and their medication compliance and relapse within 1 year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate the epidemiological characteristics, risk factors&#xD;
      (such as hypertension, diabetes, hyperlipidemia, coronary heart disease, history of previous&#xD;
      stroke, smoking, and alcohol consumption), clinical characteristics in patients with ESUS and&#xD;
      their medication compliance and relapse within 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">September 1, 2017</completion_date>
  <primary_completion_date type="Actual">September 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Medication adherence</measure>
    <time_frame>1 year after recruitment</time_frame>
    <description>Medication adherence usually refers to whether patients take their medications as prescribed (eg, twice daily), as well as whether they continue to take a prescribed medication. The Morisky scale, a validated, 4-item self-reported adherence measure that has been shown to be predictive of adherence to cardiovascular medications and blood pressure control. If a patient scores higher on the scale, they are evaluated as more adherent. If they score lower on the scale, they are presumed to be struggling with nonadherence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recurrence rate</measure>
    <time_frame>1 year after recruitment</time_frame>
    <description>Recurrence rate of stroke</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Embolic Stroke of Undetermined Source</condition>
  <arm_group>
    <arm_group_label>ESUS</arm_group_label>
    <description>Embolic stroke of undetermined source (ESUS) designates patients with nonlacunar cryptogenic ischemic strokes in whom embolism is the likely stroke mechanism.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ESUS</intervention_name>
    <description>Embolic stroke of undetermined source (ESUS) designates patients with nonlacunar cryptogenic ischemic strokes in whom embolism is the likely stroke mechanism.</description>
    <arm_group_label>ESUS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We recruited consecutive patients with Embolism Stroke of Unknown Cause.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients diagnosed with acute cerebral infarction and treated in Peking University Third&#xD;
        Hospital Neurology Department from January 2010 to June 2016.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lacunar infarction&#xD;
&#xD;
          -  Aortic atherosclerotic cerebral infarction&#xD;
&#xD;
          -  Clear cardiogenic cerebral infarction&#xD;
&#xD;
          -  Other related system diseases (arteritis, vascular dissection, migraine and vasospasm,&#xD;
             etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dongsheng Fan, MD.PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Embolic Stroke</mesh_term>
    <mesh_term>Embolism</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/NCT04455529
org study id: PUTH2016144
nct id: NCT04455529
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluate the epidemiological characteristics, risk factors, clinical characteristics in
      patients with ESUS and their medication compliance and relapse within 1 year.
The purpose of this study is to evaluate the epidemiological characteristics, risk factors
      (such as hypertension, diabetes, hyperlipidemia, coronary heart disease, history of previous
      stroke, smoking, and alcohol consumption), clinical characteristics in patients with ESUS and
      their medication compliance and relapse within 1 year.
observational model: Case-Only
time perspective: Retrospective
measure: Medication adherence
time frame: 1 year after recruitment
description: Medication adherence usually refers to whether patients take their medications as prescribed (eg, twice daily), as well as whether they continue to take a prescribed medication. The Morisky scale, a validated, 4-item self-reported adherence measure that has been shown to be predictive of adherence to cardiovascular medications and blood pressure control. If a patient scores higher on the scale, they are evaluated as more adherent. If they score lower on the scale, they are presumed to be struggling with nonadherence.
measure: Recurrence rate
time frame: 1 year after recruitment
description: Recurrence rate of stroke
arm group label: ESUS
description: Embolic stroke of undetermined source (ESUS) designates patients with nonlacunar cryptogenic ischemic strokes in whom embolism is the likely stroke mechanism.
intervention type: Other
intervention name: ESUS
description: Embolic stroke of undetermined source (ESUS) designates patients with nonlacunar cryptogenic ischemic strokes in whom embolism is the likely stroke mechanism.
arm group label: ESUS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dongsheng Fan, MD.PHD
role: Principal Investigator
affiliation: Peking University Third Hospital
responsible party type: Sponsor
mesh term: Stroke
mesh term: Embolic Stroke
mesh term: Embolism
sharing ipd: No