<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/NCT02201264</url>
  </required_header>
  <id_info>
    <org_study_id>11.2</org_study_id>
    <nct_id>NCT02201264</nct_id>
  </id_info>
  <brief_title>Cardiovascular Patient Outcomes and Research Team Primary PCI Registry</brief_title>
  <acronym>CPORT</acronym>
  <official_title>The Atlantic CPORT Primary PCI Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study is a registry of patients treated with primary angioplasty for acute&#xD;
      myocardial infarction.&#xD;
&#xD;
      The aim of this registry is to define the outcomes of patients treated for acute, ST-segment&#xD;
      myocardial infarction (STEMI) at community hospitals without on-site cardiac surgery programs&#xD;
      that have completed the Cardiovascular Patient Outcomes and Research Team (C-PORT) Primary&#xD;
      Angioplasty Development program. The primary medical outcome for the registry is the combined&#xD;
      incidence of death, recurrent non-fatal myocardial infarction and stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary study endpoint is the composite incidence of death, non-fatal reinfarction and&#xD;
      stroke 6 weeks after index myocardial infarction.&#xD;
&#xD;
      Secondary endpoints include:&#xD;
&#xD;
        1. composite of death, recurrent non-fatal MI and stroke at hospital discharge and at 6&#xD;
           months&#xD;
&#xD;
        2. specific subgroup analyses are planned based on history of diabetes age anterior versus&#xD;
           other infarct locations race gender&#xD;
&#xD;
        3. incidence of complications including significant bleeding, need for coronary artery&#xD;
           bypass surgery, cardiac arrest&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2006</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Days</target_duration>
  <primary_outcome>
    <measure>Composite incidence of death, non-fatal reinfarction and stroke.</measure>
    <time_frame>6 weeks after myocardial infarction</time_frame>
    <description>The primary study endpoint is the composite incidence of death, non-fatal reinfarction and stroke 6 weeks after index myocardial infarction.&#xD;
Secondary endpoints include:&#xD;
composite of death, recurrent non-fatal MI and stroke at hospital discharge and at 6 months&#xD;
specific subgroup analyses are planned based on history of diabetes age anterior versus other infarct locations race gender&#xD;
incidence of complications including significant bleeding, need for coronary artery bypass surgery, cardiac arrest</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">6726</enrollment>
  <condition>ST Elevation Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Primary PCI for STEMI patients</arm_group_label>
    <description>Primary PCI for patients presenting with ST elevation MIs</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        acute myocardial infarction with&#xD;
&#xD;
          1. &gt; 30 mins ongoing ischemic cardiac pain at presentation and &gt; 0.1 mv ST-segment&#xD;
             elevation in 2 or more contiguous ECG leads or&#xD;
&#xD;
          2. new or suspected new LBBB or&#xD;
&#xD;
          3. &gt; 0.1 mv ST-segment depression in V1 and V2 consistent with true posterior infarction&#xD;
             cardiogenic shock - (defined as systolic blood pressure &lt;80 mmHg sustained for more&#xD;
             than 30 minutes despite correction of non-myocardial factors (hypovolemia, acidosis,&#xD;
             arrhythmia, etc) or requirement for pressors and/or IABP to sustain systolic blood&#xD;
             pressure &gt; 80 mmHg)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age &gt; 18 years&#xD;
&#xD;
          2. ability to give informed consent&#xD;
&#xD;
          3. acute myocardial infarction with&#xD;
&#xD;
               1. &gt; 30 mins ongoing ischemic cardiac pain at presentation and &gt; 0.1 mv ST-segment&#xD;
                  elevation in 2 or more contiguous ECG leads or&#xD;
&#xD;
               2. new or suspected new Left Bundle Branch Block (LBBB) or&#xD;
&#xD;
               3. &gt; 0.1 mv ST-segment depression in V1 and V2 consistent with true posterior&#xD;
                  infarction&#xD;
&#xD;
          4. rescue PCI for failed thrombolytics&#xD;
&#xD;
          5. cardiogenic shock - (defined as systolic blood pressure &lt;80 mmHg sustained for more&#xD;
             than 30 minutes despite correction of non-myocardial factors (hypovolemia, acidosis,&#xD;
             arrhythmia, etc) or requirement for pressors and/or intra-aortic balloon pump (IABP)&#xD;
             to sustain systolic blood pressure &gt; 80 mmHg)&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        1. inability to obtain informed consent (surrogate consent may be obtained if approved by&#xD;
        your IRB)&#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_official>
    <last_name>Thomas Aversano, MD</last_name>
    <role>Study Director</role>
    <affiliation>Johns Hopkins School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Community Health and Wellness Center</name>
      <address>
        <city>Bryan</city>
        <state>Ohio</state>
        <zip>43506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Geauga Medical Center</name>
      <address>
        <city>Chardon</city>
        <state>Ohio</state>
        <zip>44024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University East</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southview Medical Center</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fort Hamilton Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ohio</state>
        <zip>45013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marietta Memorial</name>
      <address>
        <city>Marietta</city>
        <state>Ohio</state>
        <zip>45750</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Knox Community Hospital</name>
      <address>
        <city>Mount Vernon</city>
        <state>Ohio</state>
        <zip>43050</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Licking Memorial Hospital</name>
      <address>
        <city>Newark</city>
        <state>Ohio</state>
        <zip>43055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westchester Hospital</name>
      <address>
        <city>Westchester</city>
        <state>Ohio</state>
        <zip>45069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Armstrong County Memorial Hospital</name>
      <address>
        <city>Kittanning</city>
        <state>Pennsylvania</state>
        <zip>16201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC McKeesport</name>
      <address>
        <city>McKeesport</city>
        <state>Pennsylvania</state>
        <zip>15132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meadville Medical Center</name>
      <address>
        <city>Meadville</city>
        <state>Pennsylvania</state>
        <zip>16335</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nazareth Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19152</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hospital</name>
      <address>
        <city>York</city>
        <state>Pennsylvania</state>
        <zip>17403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>October 2, 2018</last_update_submitted>
  <last_update_submitted_qc>October 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>myocardial infarction</keyword>
  <keyword>Angioplasty</keyword>
  <keyword>Stent</keyword>
  <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/NCT02201264
org study id: 11.2
nct id: NCT02201264
lead sponsor: 
has dmc: No
The proposed study is a registry of patients treated with primary angioplasty for acute
      myocardial infarction.

      The aim of this registry is to define the outcomes of patients treated for acute, ST-segment
      myocardial infarction (STEMI) at community hospitals without on-site cardiac surgery programs
      that have completed the Cardiovascular Patient Outcomes and Research Team (C-PORT) Primary
      Angioplasty Development program. The primary medical outcome for the registry is the combined
      incidence of death, recurrent non-fatal myocardial infarction and stroke.
The primary study endpoint is the composite incidence of death, non-fatal reinfarction and
      stroke 6 weeks after index myocardial infarction.

      Secondary endpoints include:

        1. composite of death, recurrent non-fatal MI and stroke at hospital discharge and at 6
           months

        2. specific subgroup analyses are planned based on history of diabetes age anterior versus
           other infarct locations race gender

        3. incidence of complications including significant bleeding, need for coronary artery
           bypass surgery, cardiac arrest
observational model: Other
time perspective: Prospective
measure: Composite incidence of death, non-fatal reinfarction and stroke.
time frame: 6 weeks after myocardial infarction
description: The primary study endpoint is the composite incidence of death, non-fatal reinfarction and stroke 6 weeks after index myocardial infarction.
Secondary endpoints include:
composite of death, recurrent non-fatal MI and stroke at hospital discharge and at 6 months
specific subgroup analyses are planned based on history of diabetes age anterior versus other infarct locations race gender
incidence of complications including significant bleeding, need for coronary artery bypass surgery, cardiac arrest
arm group label: Primary PCI for STEMI patients
description: Primary PCI for patients presenting with ST elevation MIs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Aversano, MD
role: Study Director
affiliation: Johns Hopkins School of Medicine
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country: United States
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction