<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/NCT03763968</url>
  </required_header>
  <id_info>
    <org_study_id>YGuo</org_study_id>
    <nct_id>NCT03763968</nct_id>
  </id_info>
  <brief_title>Multicentre REtrospective StuDy of Treatment and OUtComes in STEMI Patients in Fujian Province</brief_title>
  <acronym>REDUCTION</acronym>
  <official_title>Multicentre REtrospective StuDy of Treatment and OUtComes in ST-elevatION Myocardial Infarction(STEMI) Patients in Fujian Province</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yan-song Guo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Longyan City First Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Hospital of Putian University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Fujian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The MinDong Hospital of Ningde City</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fujian Provincial Hospital</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 multicentre observational study planned to gather follow up data for a period of 1&#xD;
      year in order to understand the treatments and outcomes of ST-segment elevation myocardial&#xD;
      infarction(STEMI) and improve medical care quality in Fujian province for China. Consecutive&#xD;
      patients who were admitted and diagnosed with STEMI between January 2014 December 2018 were&#xD;
      conducted at five regional representative hospitals in Fujian province, which included the&#xD;
      Fujian Provincial Hospital,Longyan First Hospital, the affiliated hospital of putian&#xD;
      university,the Second Affiliated Hospital of Fujian Medical University and Mindong Hospital&#xD;
      of Ningde City.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>In-hospital mortality</measure>
    <time_frame>5years</time_frame>
    <description>all mortality,cardiovascular mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>other in-hospital complications</measure>
    <time_frame>5years</time_frame>
    <description>recurrent myocardial infarction, target vessel revascularization,contrast-induced acute kidney injury,stroke,bleeding,and so on</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MACEs for long-term follow up</measure>
    <time_frame>1 year</time_frame>
    <description>mortality,stent restenosis, recurrent myocardial infarction, and target vessel revascularization,stroke,bleeding,and so on</description>
  </secondary_outcome>
  <enrollment type="Actual">7000</enrollment>
  <condition>ST-segment Elevation Myocardial Infarction</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>treatment and outcome</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        STEMI patients with symptom onset within 30 days&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  STEMI patients with symptom onset within 30 days&#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_official>
    <last_name>Kai-yang Lin, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fujian Provincial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fujian Provincial</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>January 1, 2019</last_update_submitted>
  <last_update_submitted_qc>January 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Fujian Provincial Hospital</investigator_affiliation>
    <investigator_full_name>Yan-song Guo</investigator_full_name>
    <investigator_title>Fujian Provincial Hospital</investigator_title>
  </responsible_party>
  <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>
  <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/NCT03763968
org study id: YGuo
nct id: NCT03763968
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a multicentre observational study planned to gather follow up data for a period of 1
      year in order to understand the treatments and outcomes of ST-segment elevation myocardial
      infarction(STEMI) and improve medical care quality in Fujian province for China. Consecutive
      patients who were admitted and diagnosed with STEMI between January 2014 December 2018 were
      conducted at five regional representative hospitals in Fujian province, which included the
      Fujian Provincial Hospital,Longyan First Hospital, the affiliated hospital of putian
      university,the Second Affiliated Hospital of Fujian Medical University and Mindong Hospital
      of Ningde City.
observational model: Cohort
time perspective: Retrospective
measure: In-hospital mortality
time frame: 5years
description: all mortality,cardiovascular mortality
measure: other in-hospital complications
time frame: 5years
description: recurrent myocardial infarction, target vessel revascularization,contrast-induced acute kidney injury,stroke,bleeding,and so on
measure: MACEs for long-term follow up
time frame: 1 year
description: mortality,stent restenosis, recurrent myocardial infarction, and target vessel revascularization,stroke,bleeding,and so on
intervention type: Other
intervention name: treatment and outcome
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Kai-yang Lin, Doctor
role: Principal Investigator
affiliation: Fujian Provincial Hospital
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Fujian Provincial Hospital
investigator full name: Yan-song Guo
investigator title: Fujian Provincial Hospital
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
sharing ipd: No