<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/NCT03011879</url>
  </required_header>
  <id_info>
    <org_study_id>CSCAP-2</org_study_id>
    <nct_id>NCT03011879</nct_id>
  </id_info>
  <brief_title>China STEMI Care Project Phase 2</brief_title>
  <official_title>China STEMI Care Project Phase 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese Medical Doctor Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The program is to improve STEMI medical care quality in China. With the documents issued by&#xD;
      National Health and Family Planning Commission of the People's Republic of China, the program&#xD;
      was initialed in at least 200 primary PCI capable hospitals together with hundreds of&#xD;
      adjacent non-primary PCI capable hospitals in 15 provinces. STEMI patients with symptom onset&#xD;
      within 30 days will be enrolled in 3 periods. In each period with 6-month interval, 30&#xD;
      patients will be enrolled consecutively from each PCI-capable center initially and from&#xD;
      non-primary PCI capable hospitals later, thus at least 18,000 STEMI patients from primary PCI&#xD;
      capable hospitals will be enrolled and all of them will be followed up for 1 year. Key&#xD;
      performance indicators (KPIs) in STEMI care will be collected using both national PCI online&#xD;
      registry and a program STEMI online registry database for the purpose of improvement of&#xD;
      medical care. Hospital KPIs rank report and problem-based resolution will be feedback to each&#xD;
      hospital after data analysis in each period. Comparison of every two cross-sectional data&#xD;
      (self) and within one cross-sectional (inter-hospital) data will be used to evaluate the&#xD;
      improvement of medical quality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2015</start_date>
  <primary_completion_date type="Anticipated">December 2017</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>Referfusion ratio in patients with symptom onset within 12 hours</measure>
    <time_frame>12 hours</time_frame>
    <description>Referfusion including primary PCI and thrombolysis is the key strategy in STEMI care</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Door-to-ballnoon time in patients with symptom onset within 12 hours</measure>
    <time_frame>12 hours</time_frame>
    <description>Door-to-ballnoon time is the key index to evaluate treatment of primary PCI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Door-to-needle time in patients with symptom onset within 12 hours</measure>
    <time_frame>12 hours</time_frame>
    <description>Door-to-needle time is the key index to evaluate treatment of thrombolysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital admission via ambulance ratio</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom onset to arrive in hospital</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Bypass ED ratio in patients with symptom onset within 12 hours</measure>
    <time_frame>12 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Usage of both DAPT, statin, β blocker and ACEI/ARB in patients without contraindication</measure>
    <time_frame>3 yeras</time_frame>
    <description>DAPT means dual antiplatelet therapy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In-hospital morbidity</measure>
    <time_frame>2 yeras</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>1-year on time follow-up ratio</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">18000</enrollment>
  <condition>ST-Elevation Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>1.STEMI patients with symptom onset within 30 days</arm_group_label>
    <description>First round enrollment of STEMI patients with symptom onset within 30 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2.STEMI patients with symptom onset within 30 days</arm_group_label>
    <description>Second round enrollment of STEMI patients with symptom onset within 30 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3.STEMI patients with symptom onset within 30 days</arm_group_label>
    <description>Third round enrollment of STEMI patients with symptom onset within 30 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>clinical pathway</intervention_name>
    <arm_group_label>1.STEMI patients with symptom onset within 30 days</arm_group_label>
    <arm_group_label>2.STEMI patients with symptom onset within 30 days</arm_group_label>
    <arm_group_label>3.STEMI patients with symptom onset within 30 days</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      patients under thrombolysis&#xD;
    </textblock>
  </biospec_descr>
  <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;
          -  None&#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>8610-83575728</phone>
    <email>drzhy1108@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Cardiology, Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yan Zhang, MD</last_name>
      <phone>8610-83575728</phone>
      <email>drzhy1108@163.com</email>
    </contact>
    <investigator>
      <last_name>Yong Huo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</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>
  <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/NCT03011879
org study id: CSCAP-2
nct id: NCT03011879
lead sponsor: 
collaborator: 
has dmc: Yes
The program is to improve STEMI medical care quality in China. With the documents issued by
      National Health and Family Planning Commission of the People's Republic of China, the program
      was initialed in at least 200 primary PCI capable hospitals together with hundreds of
      adjacent non-primary PCI capable hospitals in 15 provinces. STEMI patients with symptom onset
      within 30 days will be enrolled in 3 periods. In each period with 6-month interval, 30
      patients will be enrolled consecutively from each PCI-capable center initially and from
      non-primary PCI capable hospitals later, thus at least 18,000 STEMI patients from primary PCI
      capable hospitals will be enrolled and all of them will be followed up for 1 year. Key
      performance indicators (KPIs) in STEMI care will be collected using both national PCI online
      registry and a program STEMI online registry database for the purpose of improvement of
      medical care. Hospital KPIs rank report and problem-based resolution will be feedback to each
      hospital after data analysis in each period. Comparison of every two cross-sectional data
      (self) and within one cross-sectional (inter-hospital) data will be used to evaluate the
      improvement of medical quality.
observational model: Cohort
time perspective: Prospective
measure: Referfusion ratio in patients with symptom onset within 12 hours
time frame: 12 hours
description: Referfusion including primary PCI and thrombolysis is the key strategy in STEMI care
measure: Door-to-ballnoon time in patients with symptom onset within 12 hours
time frame: 12 hours
description: Door-to-ballnoon time is the key index to evaluate treatment of primary PCI
measure: Door-to-needle time in patients with symptom onset within 12 hours
time frame: 12 hours
description: Door-to-needle time is the key index to evaluate treatment of thrombolysis
measure: Hospital admission via ambulance ratio
time frame: 2 years
measure: Symptom onset to arrive in hospital
time frame: 2 years
measure: Bypass ED ratio in patients with symptom onset within 12 hours
time frame: 12 hours
measure: Usage of both DAPT, statin, β blocker and ACEI/ARB in patients without contraindication
time frame: 3 yeras
description: DAPT means dual antiplatelet therapy
measure: In-hospital morbidity
time frame: 2 yeras
measure: 1-year on time follow-up ratio
time frame: 1 year
arm group label: 1.STEMI patients with symptom onset within 30 days
description: First round enrollment of STEMI patients with symptom onset within 30 days
arm group label: 2.STEMI patients with symptom onset within 30 days
description: Second round enrollment of STEMI patients with symptom onset within 30 days
arm group label: 3.STEMI patients with symptom onset within 30 days
description: Third round enrollment of STEMI patients with symptom onset within 30 days
intervention type: Other
intervention name: clinical pathway
arm group label: 1.STEMI patients with symptom onset within 30 days
arm group label: 2.STEMI patients with symptom onset within 30 days
arm group label: 3.STEMI patients with symptom onset within 30 days
patients under thrombolysis
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: 8610-83575728
email: drzhy1108@163.com
facility: 
status: Recruiting
contact: 
investigator: 
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
sharing ipd: No