<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/NCT03821012</url>
  </required_header>
  <id_info>
    <org_study_id>CSCAP</org_study_id>
    <nct_id>NCT03821012</nct_id>
  </id_info>
  <brief_title>China STEMI Care Project</brief_title>
  <official_title>China STEMI Care Project: a 10-year Project to Improve Quality of Care by Building up the a Regional STEMI Care Network</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      The China ST-elevation myocardial infarction (STEMI) Care Project (CSCAP) aims to improve the&#xD;
      reperfusion treatment rate and shorten the total duration of myocardial ischemia by&#xD;
      establishing a regional STEMI treatment network covering the whole-city region, whole-city&#xD;
      population, and whole-disease process step by step. The CSCAP is a prospective, multicenter&#xD;
      registry involving three phases. A total of 18 provinces, 4 municipalities, and 2 autonomous&#xD;
      regions in China were included. Patients with STEMI who met with the third acute myocardial&#xD;
      infarction definition and the Chinese STEMI diagnosis and treatment guidelines were enrolled&#xD;
      and the estimated number is over 50,000. Phase 1 (CSCAP-1) focused on the in-hospital process&#xD;
      optimization of primary percutaneous coronary intervention (PPCI) hospitals. Phase 2&#xD;
      (CSCAP-2) focused on the PPCI hospital-based regional STEMI transfer network, including&#xD;
      emergency medical services and non-PPCI hospitals. Phase 3 (CSCAP-3) focused on the&#xD;
      whole-city STEMI care network construction by promoting chest pain center accreditation.&#xD;
      Systematic data collection, assessment of quality of care, and subsequent improvement were&#xD;
      implemented throughout the project to continuously improve the quality of care for patients&#xD;
      with STEMI.&#xD;
&#xD;
      CSCAP is the first project that focused on establishing a regional STEMI emergency care&#xD;
      network in China to help understand the condition of STEMI care in China extensively.&#xD;
      Moreover, its objective was to optimize the quality of STEMI care through in-hospital process&#xD;
      optimization (2012-2013), PPCI hospital-based regional STEMI transfer network construction&#xD;
      (2015-2018), and construction of the whole-city STEMI care network step by step (2018-2021).&#xD;
      However, hospitals were not randomly selected in CSCAP, which might be because of the lack of&#xD;
      representatives to some degree. Alternatively, it focused on providing a tailored&#xD;
      quality-of-care improvement plan based on the conditions of different regions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2011</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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 total duration of myocardial ischemia</measure>
    <time_frame>12 hours</time_frame>
    <description>Median time from symptom onset to target vessel open in STEMI patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the reperfusion treatment ratio</measure>
    <time_frame>12 hours</time_frame>
    <description>the ratio of primary PCI plus thrombolysis usage in STEMI patients</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">50000</enrollment>
  <condition>ST-Elevation Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>CSCAP-1</arm_group_label>
    <description>STEMI with symptom onset within 12 h regardless of whether receiving reperfusion or symptom onset within 12-24 h of needing PPCI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSCAP-2</arm_group_label>
    <description>STEMI patients with symptom onset within 30 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSCAP-3</arm_group_label>
    <description>STEMI patients with symptom onset within 30 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>in-hospital process optimization</intervention_name>
    <arm_group_label>CSCAP-1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PPCI hospital-based regional STEMI transfer network construction</intervention_name>
    <arm_group_label>CSCAP-2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>the whole-city STEMI care network construction</intervention_name>
    <arm_group_label>CSCAP-3</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        In CSCAP-1, a total of 4191 patients admitted to hospitals, with symptom onset within 12 h,&#xD;
        regardless of whether receiving reperfusion or symptom onset within 12-24 h of needing&#xD;
        PPCI, were enrolled consecutively in 53 tertiary hospitals qualified for PPCI in 14&#xD;
        provinces/municipalities/autonomous regions of China in 2012.&#xD;
&#xD;
        In CSCAP-2, a total of 20,799 patients with STEMI occurrence within 30 days, regardless of&#xD;
        reperfusion, were enrolled consecutively from PPCI hospitals 3 times at a 6-month interval&#xD;
        in 244 PCI hospitals with hundreds of adjunct non-PCI hospitals from 24&#xD;
        provinces/municipalities/autonomous regions from 2015 to 2018.&#xD;
&#xD;
        In CSCAP-3, a total of 30 hospitalized patients with symptom onset within 30 days were&#xD;
        enrolled consecutively from each hospital every 3 months. Patients with STEMI were enrolled&#xD;
        consecutively from the whole network units, including both PCI and non-PCI hospitals in 7&#xD;
        cities in China.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  STEMI patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yan Zhang, MD</last_name>
    <phone>8610-83575728</phone>
    <email>drzhy1108@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yan Zhang, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</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, Department of Cardiology</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>
  <!-- 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/NCT03821012
org study id: CSCAP
nct id: NCT03821012
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The China ST-elevation myocardial infarction (STEMI) Care Project (CSCAP) aims to improve the
      reperfusion treatment rate and shorten the total duration of myocardial ischemia by
      establishing a regional STEMI treatment network covering the whole-city region, whole-city
      population, and whole-disease process step by step. The CSCAP is a prospective, multicenter
      registry involving three phases. A total of 18 provinces, 4 municipalities, and 2 autonomous
      regions in China were included. Patients with STEMI who met with the third acute myocardial
      infarction definition and the Chinese STEMI diagnosis and treatment guidelines were enrolled
      and the estimated number is over 50,000. Phase 1 (CSCAP-1) focused on the in-hospital process
      optimization of primary percutaneous coronary intervention (PPCI) hospitals. Phase 2
      (CSCAP-2) focused on the PPCI hospital-based regional STEMI transfer network, including
      emergency medical services and non-PPCI hospitals. Phase 3 (CSCAP-3) focused on the
      whole-city STEMI care network construction by promoting chest pain center accreditation.
      Systematic data collection, assessment of quality of care, and subsequent improvement were
      implemented throughout the project to continuously improve the quality of care for patients
      with STEMI.

      CSCAP is the first project that focused on establishing a regional STEMI emergency care
      network in China to help understand the condition of STEMI care in China extensively.
      Moreover, its objective was to optimize the quality of STEMI care through in-hospital process
      optimization (2012-2013), PPCI hospital-based regional STEMI transfer network construction
      (2015-2018), and construction of the whole-city STEMI care network step by step (2018-2021).
      However, hospitals were not randomly selected in CSCAP, which might be because of the lack of
      representatives to some degree. Alternatively, it focused on providing a tailored
      quality-of-care improvement plan based on the conditions of different regions.
observational model: Cohort
time perspective: Prospective
measure: the total duration of myocardial ischemia
time frame: 12 hours
description: Median time from symptom onset to target vessel open in STEMI patients
measure: the reperfusion treatment ratio
time frame: 12 hours
description: the ratio of primary PCI plus thrombolysis usage in STEMI patients
arm group label: CSCAP-1
description: STEMI with symptom onset within 12 h regardless of whether receiving reperfusion or symptom onset within 12-24 h of needing PPCI
arm group label: CSCAP-2
description: STEMI patients with symptom onset within 30 days
arm group label: CSCAP-3
description: STEMI patients with symptom onset within 30 days
intervention type: Other
intervention name: in-hospital process optimization
arm group label: CSCAP-1
intervention type: Other
intervention name: PPCI hospital-based regional STEMI transfer network construction
arm group label: CSCAP-2
intervention type: Other
intervention name: the whole-city STEMI care network construction
arm group label: CSCAP-3
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yan Zhang, MD
phone: 8610-83575728
email: drzhy1108@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Yong Huo
investigator title: Director, Department of Cardiology
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction