<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/NCT04427735</url>
  </required_header>
  <id_info>
    <org_study_id>BFH-COVID-19 and Primary PCI</org_study_id>
    <nct_id>NCT04427735</nct_id>
  </id_info>
  <brief_title>Effect of Covid-19 Epidemic on Primary PCI in Patients With STEMI</brief_title>
  <official_title>Effect of Covid-19 Epidemic on Primary PCI and Prognosis in Patients With Acute STEMI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Friendship Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The epidemic of covid-19 has spread all over the world and has a great impact on people's&#xD;
      health and life. It is necessary to study the treatment of STEMI patients in the real world&#xD;
      under the influence of the epidemic,which provide effective suggestions and strategies for&#xD;
      emergency and severe treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The epidemic of covid-19 has spread all over the world and has a great impact on people's&#xD;
      health and life. The patients' prognosis is poor because the epidemic situation runs on&#xD;
      medical resources, delays the diagnosis and treatment of other diseases such as&#xD;
      cardiovascular diseases, and the patients' willingness to see a doctor is reduced. In&#xD;
      particular, the delay in the treatment of STEMI, which needs PCI treatment, will cause more&#xD;
      damage to the patients. It is necessary to study the treatment of STEMI patients in the real&#xD;
      world under the influence of the epidemic. In this study, STEMI patients who experienced&#xD;
      emergency PCI treatment after the covid-19 outbreak in 2020 were included, and compared with&#xD;
      the data of the same period in 2019,we will analyze the pre hospital treatment time, vascular&#xD;
      opening time,and the major cardiovascular adverse events, which provide effective suggestions&#xD;
      and strategies for emergency and severe treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 24, 2019</start_date>
  <completion_date type="Anticipated">July 24, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 24, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MACE (major adverse cardiovascular events)</measure>
    <time_frame>1 year</time_frame>
    <description>cardiovascular death, re-infarction, malignant arrhythmia,heart failure, revascularization, and stroke</description>
  </primary_outcome>
  <primary_outcome>
    <measure>all-cause death</measure>
    <time_frame>1 year</time_frame>
    <description>death caused by all reason</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>STEMI</condition>
  <arm_group>
    <arm_group_label>before COVID-19</arm_group_label>
    <description>Patients with myocardial infarction from January 24, 2019 to June 24, 2019</description>
  </arm_group>
  <arm_group>
    <arm_group_label>after COVID-19</arm_group_label>
    <description>Patients with myocardial infarction from January 24, 2020 to June 24, 2020</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients with definite diagnosis of acute ST segment elevation myocardial infarction and&#xD;
        emergency PCI intervention&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Continuous inclusion of patients with definite diagnosis of acute ST segment elevation&#xD;
             myocardial infarction and emergency PCI intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Febrile patients, patients with severe infection,&#xD;
&#xD;
          -  ST segment elevation myocardial infarction during hospitalization,&#xD;
&#xD;
          -  Patients who could not cooperate with each other.&#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>Hongwei Li</last_name>
    <role>Study Chair</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hongwei Li, doctor</last_name>
    <phone>0086 10 63139780</phone>
    <email>lhw19656@sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Friendship Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongwei Li</last_name>
      <phone>0086 10 63139780</phone>
      <email>lhw19656@sina.com</email>
    </contact>
    <contact_backup>
      <last_name>Xuhe Gong</last_name>
      <phone>0086 10 63139780</phone>
      <email>gongxuhe123@126.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Hongwei Li, MD</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>covid-19</keyword>
  <keyword>STEMI</keyword>
  <keyword>primary PCI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>ST Elevation Myocardial 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/NCT04427735
org study id: BFH-COVID-19 and Primary PCI
nct id: NCT04427735
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The epidemic of covid-19 has spread all over the world and has a great impact on people's
      health and life. It is necessary to study the treatment of STEMI patients in the real world
      under the influence of the epidemic,which provide effective suggestions and strategies for
      emergency and severe treatment.
The epidemic of covid-19 has spread all over the world and has a great impact on people's
      health and life. The patients' prognosis is poor because the epidemic situation runs on
      medical resources, delays the diagnosis and treatment of other diseases such as
      cardiovascular diseases, and the patients' willingness to see a doctor is reduced. In
      particular, the delay in the treatment of STEMI, which needs PCI treatment, will cause more
      damage to the patients. It is necessary to study the treatment of STEMI patients in the real
      world under the influence of the epidemic. In this study, STEMI patients who experienced
      emergency PCI treatment after the covid-19 outbreak in 2020 were included, and compared with
      the data of the same period in 2019,we will analyze the pre hospital treatment time, vascular
      opening time,and the major cardiovascular adverse events, which provide effective suggestions
      and strategies for emergency and severe treatment.
observational model: Case-Crossover
time perspective: Cross-Sectional
measure: MACE (major adverse cardiovascular events)
time frame: 1 year
description: cardiovascular death, re-infarction, malignant arrhythmia,heart failure, revascularization, and stroke
measure: all-cause death
time frame: 1 year
description: death caused by all reason
arm group label: before COVID-19
description: Patients with myocardial infarction from January 24, 2019 to June 24, 2019
arm group label: after COVID-19
description: Patients with myocardial infarction from January 24, 2020 to June 24, 2020
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Hongwei Li
role: Study Chair
affiliation: Beijing Friendship Hospital
last name: Hongwei Li, doctor
phone: 0086 10 63139780
email: lhw19656@sina.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Friendship Hospital
investigator full name: Hongwei Li, MD
investigator title: professor
mesh term: COVID-19
mesh term: ST Elevation Myocardial Infarction