<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/NCT01716884</url>
  </required_header>
  <id_info>
    <org_study_id>2011[436]</org_study_id>
    <nct_id>NCT01716884</nct_id>
  </id_info>
  <brief_title>China STEMI-PCI Program</brief_title>
  <official_title>China STEMI-PCI Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Registration&#xD;
&#xD;
        2. Performing in three stages&#xD;
&#xD;
        3. Major aim: Much more and standard reperfusion therapy in STEMI patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2011</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>The reperfusion ratio</measure>
    <time_frame>up to 1 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Door to Balloon time</measure>
    <time_frame>up to 1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMS ratio</measure>
    <time_frame>up to 1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>health economic evaluation</measure>
    <time_frame>up to 1 year</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>ST Segment Elevation Myocardial Infarction</condition>
  <eligibility>
    <study_pop>
      <textblock>
        STEMI Patients enrolled and followed up 1 year&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Onset of STEMI within 12h&#xD;
&#xD;
          -  Onset of STEMI within 12-36h needing primary PCI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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_contact>
    <last_name>Yan Zhang, MD</last_name>
    <phone>8610-83575180</phone>
    <email>drzhy1108@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Division of Cardiology, Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Yong Huo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>October 26, 2012</last_update_submitted>
  <last_update_submitted_qc>October 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Yong Huo</investigator_full_name>
    <investigator_title>Director of cardiovascular department</investigator_title>
  </responsible_party>
  <keyword>STEMI</keyword>
  <keyword>reperfution</keyword>
  <keyword>primary PCI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation 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/NCT01716884
org study id: 2011[436]
nct id: NCT01716884
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
1. Registration

        2. Performing in three stages

        3. Major aim: Much more and standard reperfusion therapy in STEMI patients
observational model: Cohort
time perspective: Prospective
measure: The reperfusion ratio
time frame: up to 1 day
measure: Door to Balloon time
time frame: up to 1 day
measure: BMS ratio
time frame: up to 1 day
measure: health economic evaluation
time frame: up to 1 year
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yan Zhang, MD
phone: 8610-83575180
email: drzhy1108@163.com
facility: 
status: Recruiting
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Yong Huo
investigator title: Director of cardiovascular department
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction