<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/NCT04451967</url>
  </required_header>
  <id_info>
    <org_study_id>SecondJilinU-AMINoC</org_study_id>
    <nct_id>NCT04451967</nct_id>
  </id_info>
  <brief_title>Acute Myocardial Infarction Study in Northeastern China</brief_title>
  <official_title>the Acute Myocardial Infarction Study in Northeastern China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yanbian University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dunhua City Hospital in Jilin Province</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liaoyuan City Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dongliao People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Songyuan Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Changling People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Siping Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First People's Hospital of Manchu Autonomous County</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Changchun Center Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nongan People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beihua University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jilin Hospital of Integrated Traditional Chinese and Western Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Panshi City Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tonghua Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baishan Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jingyu People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Meihekou Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baicheng Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tongyu First Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Second Hospital of Jilin 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>
      This is a real-world prospective cohort study aiming to generate knowledge about the&#xD;
      characteristics, treatments, and outcomes of hospitalized AMI patients in Jilin Province. The&#xD;
      study includes hospitalizations diagnosed of AMI, including ST segment-elevation myocardial&#xD;
      infarction (STEMI) and non-ST-segment-elevation myocardial infarction (NSTEMI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 9, 2019</start_date>
  <completion_date type="Anticipated">September 9, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 9, 2020</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>all-cause death</measure>
    <time_frame>2 years post discharge</time_frame>
    <description>all-cause death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>major adverse cardiac events (MACE)</measure>
    <time_frame>2 years post discharge</time_frame>
    <description>recurrent angina, non-fatal myocardial infarction, cardiac failure, malignant arrhythmia, and death from cardiovascular causes</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">3159</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Transfer after thrombolysis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Transfer after DAPT</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Direct transfer</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>thrombolysis</intervention_name>
    <description>transfer after thrombolysis for STEMI patients within 6h since onset</description>
    <arm_group_label>Transfer after thrombolysis</arm_group_label>
    <other_name>DAPT</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible patients must be admitted within 7 days of acute myocardial ischemic symptoms with&#xD;
        a primary clinical diagnosis of AMI, including ST-segment elevation myocardial infarction&#xD;
        (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI). Final inclusion&#xD;
        criteria must meet Fourth Universal Definition for Myocardial Infarction (2018)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients admitted within 7 days of acute myocardial ischemic symptoms with a primary&#xD;
             clinical diagnosis of AMI, meet Fourth Universal Definition for Myocardial Infarction&#xD;
             (2018)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Types 4a and type 5 AMI&#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>Bin Liu, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second Hospital of Jilin University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tianyi Li, Ph.D</last_name>
    <phone>+8615843024731</phone>
    <email>litianyi@jlu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>The second hospital of Jilin university</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>He Wang, Doctor</last_name>
      <phone>043188796625</phone>
      <email>wanghe221@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 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>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <!-- 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/NCT04451967
org study id: SecondJilinU-AMINoC
nct id: NCT04451967
lead sponsor: 
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has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a real-world prospective cohort study aiming to generate knowledge about the
      characteristics, treatments, and outcomes of hospitalized AMI patients in Jilin Province. The
      study includes hospitalizations diagnosed of AMI, including ST segment-elevation myocardial
      infarction (STEMI) and non-ST-segment-elevation myocardial infarction (NSTEMI).
observational model: Cohort
time perspective: Prospective
measure: all-cause death
time frame: 2 years post discharge
description: all-cause death
measure: major adverse cardiac events (MACE)
time frame: 2 years post discharge
description: recurrent angina, non-fatal myocardial infarction, cardiac failure, malignant arrhythmia, and death from cardiovascular causes
arm group label: Transfer after thrombolysis
arm group label: Transfer after DAPT
arm group label: Direct transfer
intervention type: Procedure
intervention name: thrombolysis
description: transfer after thrombolysis for STEMI patients within 6h since onset
arm group label: Transfer after thrombolysis
other name: DAPT
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bin Liu, Ph.D
role: Principal Investigator
affiliation: Second Hospital of Jilin University
last name: Tianyi Li, Ph.D
phone: +8615843024731
email: litianyi@jlu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction