<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/NCT04412655</url>
  </required_header>
  <id_info>
    <org_study_id>115/20</org_study_id>
    <nct_id>NCT04412655</nct_id>
  </id_info>
  <brief_title>Primary Angioplasty for STEMI During COVID-19 Pandemic (ISACS-STEMI COVID-19) Registry</brief_title>
  <acronym>ISACS-STEMI</acronym>
  <official_title>International Study on Acute Coronary Syndromes - ST-segment Elevation Myocardial Infarction COVID 19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi del Piemonte Orientale &quot;Amedeo Avogadro&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi del Piemonte Orientale &quot;Amedeo Avogadro&quot;</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 ISACS STEMI COVID-19 has been established in response to the emerging outbreak of&#xD;
      COVID-19 to provide a European overview to estimate the real impact of COVID-19 pandemic on&#xD;
      treatment and outcome of STEMI by primary angioplasty, and to identify any potential category&#xD;
      of patients at risk for delay to treatment or no presentation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a retrospective multicenter registry including at least 40 European primary PCI&#xD;
      centers with &gt; 120 primary PCI/year (with expected average &gt; 10/month), with the case load of&#xD;
      STEMI not expected to be affected by a potential planned reorganization of the STEMI network.&#xD;
      The inclusion period will be of 2 months (from March 1st until April 30th). The data will be&#xD;
      compared with those retrospectively collected in the same time window of 2019.&#xD;
&#xD;
      Inclusion criteria: STEMI treated by primary angioplasty. Primary study outcome: Number of&#xD;
      STEMI patients undergoing primary angioplasty. Secondary study outcomes: Ischemia time and&#xD;
      the number of late presenters (&gt; 12 hours from symptoms onset); 3) Door-to-balloon time and&#xD;
      the number of patients with a DTB &gt; 30 minutes); 4) In-Hospital mortality.&#xD;
&#xD;
      Data Collection: Data will be collected anonymized through a dedicated CRF. Each center will&#xD;
      identify a local Principal Investigator. We will collect information on the study center,&#xD;
      demographic, clinical, procedural data. Furthermore, we will collect data on total ischemia&#xD;
      time, door-to-balloon time, type of access to the emergency system, COVID positivity, PCI&#xD;
      procedure, data on in-hospital mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 5, 2020</start_date>
  <completion_date type="Anticipated">June 2, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2020</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>Number of patients undergoing primary angioplasty</measure>
    <time_frame>March April 2019 and 2020</time_frame>
    <description>Number of patients undergoing primary angioplasty</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients undergoing primary angioplasty later than 12 hours from symptoms onset;</measure>
    <time_frame>March April 2019 and 2020</time_frame>
    <description>Number of patients undergoing primary angioplasty later 12 hours from symptoms onset;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients undergoing primary angioplasty later than 30 minutes from PCI hospital admission</measure>
    <time_frame>March April 2019 and 2020</time_frame>
    <description>Number of patients undergoing primary angioplasty later than 30 minutes from PCI hospital admission</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In-hospital mortality</measure>
    <time_frame>March April 2019 and 2020</time_frame>
    <description>In-Hospital mortality</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">6609</enrollment>
  <condition>ST Elevated Myocardial Infarction Undergoing Mechanical Reperfusion</condition>
  <arm_group>
    <arm_group_label>STEMI patients treated in March April 2019</arm_group_label>
    <description>Patients with STEMI undergoing mecahnical revascularization from 1th March to 30th April 2019</description>
  </arm_group>
  <arm_group>
    <arm_group_label>STEMI patients treated in March April 2020</arm_group_label>
    <description>Patients with STEMI undergoing mecahnical revascularization from 1th March to 30th April 2020</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous Coronary Revascularization for STEMI</intervention_name>
    <description>Percutaneous Mechanical Reperfusion for STEMI</description>
    <arm_group_label>STEMI patients treated in March April 2019</arm_group_label>
    <arm_group_label>STEMI patients treated in March April 2020</arm_group_label>
    <other_name>Primary angioplasty</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        STEMI Patients undergoing mechanical reperfusion&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: STEMI Patients undergoing mechanical reperfusion&#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>
  <location>
    <facility>
      <name>Giuseppe De Luca</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 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>Sponsor</responsible_party_type>
  </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/NCT04412655
org study id: 115/20
nct id: NCT04412655
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The ISACS STEMI COVID-19 has been established in response to the emerging outbreak of
      COVID-19 to provide a European overview to estimate the real impact of COVID-19 pandemic on
      treatment and outcome of STEMI by primary angioplasty, and to identify any potential category
      of patients at risk for delay to treatment or no presentation.
This is a retrospective multicenter registry including at least 40 European primary PCI
      centers with > 120 primary PCI/year (with expected average > 10/month), with the case load of
      STEMI not expected to be affected by a potential planned reorganization of the STEMI network.
      The inclusion period will be of 2 months (from March 1st until April 30th). The data will be
      compared with those retrospectively collected in the same time window of 2019.

      Inclusion criteria: STEMI treated by primary angioplasty. Primary study outcome: Number of
      STEMI patients undergoing primary angioplasty. Secondary study outcomes: Ischemia time and
      the number of late presenters (> 12 hours from symptoms onset); 3) Door-to-balloon time and
      the number of patients with a DTB > 30 minutes); 4) In-Hospital mortality.

      Data Collection: Data will be collected anonymized through a dedicated CRF. Each center will
      identify a local Principal Investigator. We will collect information on the study center,
      demographic, clinical, procedural data. Furthermore, we will collect data on total ischemia
      time, door-to-balloon time, type of access to the emergency system, COVID positivity, PCI
      procedure, data on in-hospital mortality.
observational model: Cohort
time perspective: Retrospective
measure: Number of patients undergoing primary angioplasty
time frame: March April 2019 and 2020
description: Number of patients undergoing primary angioplasty
measure: Number of patients undergoing primary angioplasty later than 12 hours from symptoms onset;
time frame: March April 2019 and 2020
description: Number of patients undergoing primary angioplasty later 12 hours from symptoms onset;
measure: Number of patients undergoing primary angioplasty later than 30 minutes from PCI hospital admission
time frame: March April 2019 and 2020
description: Number of patients undergoing primary angioplasty later than 30 minutes from PCI hospital admission
measure: In-hospital mortality
time frame: March April 2019 and 2020
description: In-Hospital mortality
arm group label: STEMI patients treated in March April 2019
description: Patients with STEMI undergoing mecahnical revascularization from 1th March to 30th April 2019
arm group label: STEMI patients treated in March April 2020
description: Patients with STEMI undergoing mecahnical revascularization from 1th March to 30th April 2020
intervention type: Device
intervention name: Percutaneous Coronary Revascularization for STEMI
description: Percutaneous Mechanical Reperfusion for STEMI
arm group label: STEMI patients treated in March April 2019
arm group label: STEMI patients treated in March April 2020
other name: Primary angioplasty
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction