<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/NCT04487340</url>
  </required_header>
  <id_info>
    <org_study_id>CASE II</org_study_id>
    <nct_id>NCT04487340</nct_id>
  </id_info>
  <brief_title>Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation</brief_title>
  <official_title>Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shaoxing People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Affiliated Hospital of Jiaxing University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Huizhou Municipal Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Jiaxing University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jinhua Center Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taizhou Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In the past three decades, the burden of stroke has increased in China and has gradually&#xD;
      become the leading cause of death. The data acquisition and medical quality management still&#xD;
      need to be improved in China. The purpose of this study was to establish online database of&#xD;
      acute stroke patients for stroke management quality evaluation in China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective multi-center registration study. The data of acute ischemic&#xD;
      stroke patients who underwent reperfusion therapy were registered on emergency platform. The&#xD;
      data of stroke patients who were hospitalized were registered on stroke meidical quality&#xD;
      control platform. The information including demographics, risk factors (history of&#xD;
      hypertension, diabetes, stroke/TIA or atrial fibrillation, etc), prior antiplatelet usage,&#xD;
      onset to door time (ODT), baseline National Institutes of Health Stroke Scale (NIHSS) score,&#xD;
      baseline infarct core volume, laboratory data, ect were recorded. Clinical outcome at 3&#xD;
      months and 1 year was assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">July 1, 2028</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2027</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Independence (mRS 0-2) at 1 year</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality at 1 year</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain hemorrhage at 24-72 hours after hospitalization</measure>
    <time_frame>72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of recurrent stroke or other vascular events at 1 year</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Independence (mRS 0-2) at 5 year</measure>
    <time_frame>5 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of recurrent stroke or other vascular events at 5 year</measure>
    <time_frame>5 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality at 5 year</measure>
    <time_frame>5 year</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">200000</enrollment>
  <condition>Stroke, Acute</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>Provide each center with relevant education of guidelines, and help the clinicians to improve medical quality.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All acute stroke patients who were admitted to hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Acute stroke patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        No&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min Lou, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Min Lou, PhD</last_name>
    <phone>13958007213</phone>
    <email>loumingxc@vip.sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Min Lou</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zexin Chen</last_name>
      <phone>13757118366</phone>
      <email>HREC2013@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>November 21, 2022</last_update_submitted>
  <last_update_submitted_qc>November 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>thrombolysis</keyword>
  <keyword>thrombectomy</keyword>
  <keyword>hospitalization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04487340
org study id: CASE II
nct id: NCT04487340
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In the past three decades, the burden of stroke has increased in China and has gradually
      become the leading cause of death. The data acquisition and medical quality management still
      need to be improved in China. The purpose of this study was to establish online database of
      acute stroke patients for stroke management quality evaluation in China.
This study is a prospective multi-center registration study. The data of acute ischemic
      stroke patients who underwent reperfusion therapy were registered on emergency platform. The
      data of stroke patients who were hospitalized were registered on stroke meidical quality
      control platform. The information including demographics, risk factors (history of
      hypertension, diabetes, stroke/TIA or atrial fibrillation, etc), prior antiplatelet usage,
      onset to door time (ODT), baseline National Institutes of Health Stroke Scale (NIHSS) score,
      baseline infarct core volume, laboratory data, ect were recorded. Clinical outcome at 3
      months and 1 year was assessed.
observational model: Case-Only
time perspective: Prospective
measure: Independence (mRS 0-2) at 1 year
time frame: 1 year
measure: All-cause mortality at 1 year
time frame: 1 year
measure: Brain hemorrhage at 24-72 hours after hospitalization
time frame: 72 hours
measure: The incidence of recurrent stroke or other vascular events at 1 year
time frame: 1 year
measure: Independence (mRS 0-2) at 5 year
time frame: 5 year
measure: The incidence of recurrent stroke or other vascular events at 5 year
time frame: 5 year
measure: All-cause mortality at 5 year
time frame: 5 year
intervention type: Behavioral
intervention name: Education
description: Provide each center with relevant education of guidelines, and help the clinicians to improve medical quality.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Min Lou, PhD
role: Study Director
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
last name: Min Lou, PhD
phone: 13958007213
email: loumingxc@vip.sina.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: Undecided