<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/NCT03024164</url>
  </required_header>
  <id_info>
    <org_study_id>REACH</org_study_id>
    <nct_id>NCT03024164</nct_id>
  </id_info>
  <brief_title>Stroke Registration of Young Adults in China</brief_title>
  <acronym>REACH</acronym>
  <official_title>Stroke Registration of Young Adults in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yi Yang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jiujiang No.1 People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dezhou People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Hospital of Yanbian University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affilated Hospital of Jiamusi University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xuchang Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Inner Mongolia People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shaoxing People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Hospital of Ningxia Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Hospital of Shenyang Military Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Siping Central People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affilated Hospital of the Medical College, Shihezi University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daqing Oilfieled General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Heilongjiang Provicial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Soochow University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Luoyang Central Hospital Affilated to Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuzhou Red Cross Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cangzhou Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Binzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Affilated Hospital of Inner Mongolia University for the Nationalities</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fudan University Pudong Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The First Hospital of Jilin University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center, prospective,continuous registry study. The investigators will include&#xD;
      3000 young adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke&#xD;
      in China. The main purpose of this study is to build the study cohort of young ischemic&#xD;
      stroke patients in China, and to compare the prognosis and stroke recurrence of young&#xD;
      patients with different ischemic stroke subtypes. Secondary objectives are trying to find&#xD;
      biomarkers of stroke recurrence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 10%-14% of all ischemic strokes occur in young adults ages 18 to 45 years old.&#xD;
      Stroke etiology in this population differs by geographic region and has greater heterogeneity&#xD;
      than in older individuals. Ascertain the definite etiologic classification in this young&#xD;
      patients might be the key point to prevent the stroke recurrence and reduce the stroke&#xD;
      burden. Advances in stroke diagnostic tests, particularly neuroimaging, refinement in&#xD;
      classification schema. In this multi-center registry study conducted in China, we determine&#xD;
      to explore the difference of prognosis and stroke recurrence of young patients with different&#xD;
      ischemic stroke subtypes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 26, 2017</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>1 Year</target_duration>
  <primary_outcome>
    <measure>Stroke recurrence</measure>
    <time_frame>1 year</time_frame>
    <description>Percentage of patients with the 1 year new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-stroke disability</measure>
    <time_frame>3 months</time_frame>
    <description>Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at 3-month follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular death</measure>
    <time_frame>3 months, 6 months and 1 year</time_frame>
    <description>Percentage of patients with the 3-month, 6-month and 1 year cardiovascular death caused by any event of the following: Any stroke (ischemic or hemorrhage), sudden cardiac death, acute myocardial infarction, heart failure, and other cardiovascular death including pulmonary embolism, rupture of aortic aneurysm, cardiovascular interventional therapy, and peripheral arterial disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other cardiovascular event</measure>
    <time_frame>3 months, 6 months and 1 year</time_frame>
    <description>Percentage of patients with the 3-month, 6-month and 1 year other cardiovascular event including non-lethal myocardial infarction, and non fatal heart failure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other systemic embolism</measure>
    <time_frame>3 months, 6 months and 1 year</time_frame>
    <description>Percentage of patients with the 3-month, 6-month and 1 year other systemic embolism except for cerebral artery, coronary artery, and pulmonary artery. Such as mesenteric arterial embolism,splenic artery embolization.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Young adult stroke patients</arm_group_label>
    <description>Young adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment following current guidelines</intervention_name>
    <description>Treatment following current guidelines</description>
    <arm_group_label>Young adult stroke patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      EDTA-blood and serum will be collected for future analysis&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Young adult patients who had their first-ever ischemic stroke symptoms within 72 hours and&#xD;
        visited one of the 22 participating medical centers in People's Republic of China.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 through 45 years, both genders&#xD;
&#xD;
          -  First-ever acute ischemic stroke&#xD;
&#xD;
          -  Onset of symptoms within 72 hours of inclusion&#xD;
&#xD;
          -  Willing to participate in follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Silent stroke&#xD;
&#xD;
          -  Failure to give their informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yi Yang, MD,PhD</last_name>
    <phone>+86-18186870008</phone>
    <email>doctor_yangyi@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhenni Guo, MD</last_name>
    <phone>+86-18186872986</phone>
    <email>zhen1ni2@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi Yang, MD, PhD</last_name>
      <phone>+86-18186870008</phone>
      <email>doctoryangyi@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 15, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The First Hospital of Jilin University</investigator_affiliation>
    <investigator_full_name>Yi Yang</investigator_full_name>
    <investigator_title>Associate dean, Director of Cerebrovascular Disease Center</investigator_title>
  </responsible_party>
  <keyword>youth; etiology; prognosis; recurrence; biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</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/NCT03024164
org study id: REACH
nct id: NCT03024164
lead sponsor: 
collaborator: 
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has dmc: No
This is a multi-center, prospective,continuous registry study. The investigators will include
      3000 young adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke
      in China. The main purpose of this study is to build the study cohort of young ischemic
      stroke patients in China, and to compare the prognosis and stroke recurrence of young
      patients with different ischemic stroke subtypes. Secondary objectives are trying to find
      biomarkers of stroke recurrence.
Approximately 10%-14% of all ischemic strokes occur in young adults ages 18 to 45 years old.
      Stroke etiology in this population differs by geographic region and has greater heterogeneity
      than in older individuals. Ascertain the definite etiologic classification in this young
      patients might be the key point to prevent the stroke recurrence and reduce the stroke
      burden. Advances in stroke diagnostic tests, particularly neuroimaging, refinement in
      classification schema. In this multi-center registry study conducted in China, we determine
      to explore the difference of prognosis and stroke recurrence of young patients with different
      ischemic stroke subtypes.
observational model: Case-Only
time perspective: Prospective
measure: Stroke recurrence
time frame: 1 year
description: Percentage of patients with the 1 year new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage)
measure: Post-stroke disability
time frame: 3 months
description: Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at 3-month follow-up.
measure: Cardiovascular death
time frame: 3 months, 6 months and 1 year
description: Percentage of patients with the 3-month, 6-month and 1 year cardiovascular death caused by any event of the following: Any stroke (ischemic or hemorrhage), sudden cardiac death, acute myocardial infarction, heart failure, and other cardiovascular death including pulmonary embolism, rupture of aortic aneurysm, cardiovascular interventional therapy, and peripheral arterial disease.
measure: Other cardiovascular event
time frame: 3 months, 6 months and 1 year
description: Percentage of patients with the 3-month, 6-month and 1 year other cardiovascular event including non-lethal myocardial infarction, and non fatal heart failure.
measure: Other systemic embolism
time frame: 3 months, 6 months and 1 year
description: Percentage of patients with the 3-month, 6-month and 1 year other systemic embolism except for cerebral artery, coronary artery, and pulmonary artery. Such as mesenteric arterial embolism,splenic artery embolization.
arm group label: Young adult stroke patients
description: Young adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke
intervention type: Other
intervention name: Treatment following current guidelines
description: Treatment following current guidelines
arm group label: Young adult stroke patients
EDTA-blood and serum will be collected for future analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Yi Yang, MD,PhD
phone: +86-18186870008
email: doctor_yangyi@hotmail.com
last name: Zhenni Guo, MD
phone: +86-18186872986
email: zhen1ni2@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: The First Hospital of Jilin University
investigator full name: Yi Yang
investigator title: Associate dean, Director of Cerebrovascular Disease Center
mesh term: Stroke
mesh term: Ischemic Stroke
sharing ipd: No