<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/NCT02194153</url>
  </required_header>
  <id_info>
    <org_study_id>1123.16</org_study_id>
    <nct_id>NCT02194153</nct_id>
  </id_info>
  <brief_title>Surveillance of Patients With Suspected Acute Myocardial Infarction That Receive Early Inhospital Thrombolysis With Metalyse</brief_title>
  <official_title>Surveillance of Patients With Suspected Acute Myocardial Infarction That Receive Prehospital or Early Inhospital (Emergency Department) Thrombolysis With Metalyse ®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Obtaining data on efficacy (e.g. complete ST-segment resolution) depending on the time of&#xD;
      treatment initiation and safety of prehospital and early hospital thrombolysis with Metalyse®&#xD;
      in a real life setting outside clinical trials.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2001</start_date>
  <primary_completion_date type="Actual">March 2003</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>Complete ST-segment resolution</measure>
    <time_frame>up to 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain relief</measure>
    <time_frame>90 min, 120 min, up to 30 days after treatment initiation</time_frame>
    <description>yes/no question</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in creatine kinase (CK)</measure>
    <time_frame>up to 24 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in creatine kinase-MB (CK-MB)</measure>
    <time_frame>up to 24 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in troponin</measure>
    <time_frame>up to 24 hours</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">351</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Metalyse</arm_group_label>
    <description>Metalyse weight-adjusted</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metalyse weight-adjusted</intervention_name>
    <arm_group_label>Metalyse</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        prehospital or emergency room patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Male and female patient with suspected myocardial infarction, e.g. during&#xD;
             transportation to the hospital by ambulance. No patient younger than 18 years.&#xD;
&#xD;
          -  Possibility of obtaining relevant information concerning indication or&#xD;
             contraindication of thrombolysis in each patient&#xD;
&#xD;
          -  Typical chest pain with a duration of more than 30 minutes&#xD;
&#xD;
          -  Definite infarction signs in a 12-lead-ECG with ST-elevation &gt; 0.1 millivolt (mV) in &gt;&#xD;
             2 leads or recent left bundle branch block with typical clinical signs&#xD;
&#xD;
          -  Symptom onset &lt;= 6 hours&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients older than 75 years (exception: patients appear much younger)&#xD;
&#xD;
          -  Low body weight&#xD;
&#xD;
          -  No persons under 18&#xD;
&#xD;
          -  contraindications according to summary of product characteristics (SPC) for Metalyse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1123/1123.16_U06-1025.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 17, 2014</last_update_submitted>
  <last_update_submitted_qc>July 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2014</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>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenecteplase</mesh_term>
  </intervention_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/NCT02194153
org study id: 1123.16
nct id: NCT02194153
lead sponsor: 
Obtaining data on efficacy (e.g. complete ST-segment resolution) depending on the time of
      treatment initiation and safety of prehospital and early hospital thrombolysis with Metalyse®
      in a real life setting outside clinical trials.
observational model: Cohort
time perspective: Prospective
measure: Complete ST-segment resolution
time frame: up to 30 days
measure: Pain relief
time frame: 90 min, 120 min, up to 30 days after treatment initiation
description: yes/no question
measure: Change in creatine kinase (CK)
time frame: up to 24 hours
measure: Change in creatine kinase-MB (CK-MB)
time frame: up to 24 hours
measure: Change in troponin
time frame: up to 24 hours
arm group label: Metalyse
description: Metalyse weight-adjusted
intervention type: Drug
intervention name: Metalyse weight-adjusted
arm group label: Metalyse
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1123/1123.16_U06-1025.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Tenecteplase