<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/NCT02235389</url>
  </required_header>
  <id_info>
    <org_study_id>135.301</org_study_id>
    <nct_id>NCT02235389</nct_id>
  </id_info>
  <brief_title>A Study of Pre-hospital Treatment of Acute Myocardial Infarction Based on Diagnosis by Interpretation of Remotely Acquired ECG and Thrombolysis With Accelerated Alteplase ( Actilyse®)</brief_title>
  <acronym>PHARAOH</acronym>
  <official_title>A Multicentre, Feasibility Study of Pre-hospital Treatment of Acute Myocardial Infarction Based on Diagnosis by Interpretation of Remotely Acquired ECG and Thrombolysis With Accelerated Alteplase ( Actilyse®). Pre-Hospital Alteplase Remote Advice of Hospital (PHARAOH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The general aim of this study was to assess the feasibility of treating acute myocardial&#xD;
      infarction (AMI) by physician-directed pre-hospital thrombosis, using accelerated alteplase&#xD;
      (Actilyse®) and a diagnostic technique involving remote electrocardiogram (ECG) acquisition&#xD;
      by paramedics&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>February 1998</start_date>
  <primary_completion_date type="Actual">December 1998</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of equipment function / reliability</measure>
    <time_frame>Up to 12 month after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time between pre-hospital evaluation and treatment</measure>
    <time_frame>Up to 12 month after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of acute myocardial infarction (AMI) patients, whose symptoms were recognized by paramedics</measure>
    <time_frame>Up to 12 month after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients correctly diagnosed as suffering acute myocardial infarction by remote ECG interpretation</measure>
    <time_frame>Up to 12 month after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients incorrectly diagnosed as suffering acute myocardial infarction by remote ECG interpretation</measure>
    <time_frame>Up to 12 month after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients receiving pre- hospital thrombolysis in the absence of a subsequently confirmed diagnosis of acute myocardial infarction</measure>
    <time_frame>Up to 12 month after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients giving consent to pre- hospital evaluation using remote electrocardiogram (ECG)</measure>
    <time_frame>Up to 12 month after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 12 month after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient status at 30 days post myocardial infarction</measure>
    <time_frame>Up to 30 days after drug administration</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">59</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Administration of thrombolytic treatment with PHARAOH</arm_group_label>
    <description>Pre-Hospital Alteplase Remote Advice of Hospital (PHARAOH)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard therapy with thrombolytic treatment in Hospital</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alteplase (Actilyse)</intervention_name>
    <arm_group_label>Administration of thrombolytic treatment with PHARAOH</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard therapy</intervention_name>
    <arm_group_label>Standard therapy with thrombolytic treatment in Hospital</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute myocardial infarction treated by paramedics under the direction of&#xD;
        hospital physicians&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ischemic cardiac pain of &gt;= 20 minutes and &lt;= 6 hours&#xD;
&#xD;
          -  Age 18 - 80 years&#xD;
&#xD;
          -  Ability to give informed consent (witnessed verbal or written)&#xD;
&#xD;
          -  Ability to follow protocol and comply with follow -up requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current participation in another clinical trial&#xD;
&#xD;
          -  Patient will be ineligible for pre hospital administration of actilyse if any of the&#xD;
             following apply:&#xD;
&#xD;
               -  Acute myocardial infarction (AMI) treated with a thrombolytic agent within the&#xD;
                  preceding 4 days&#xD;
&#xD;
               -  BP (blood pressure) &gt; 180/100 mmHg (on one measurement)&#xD;
&#xD;
               -  Significant bleeding disorder within the past 6 months&#xD;
&#xD;
               -  Major surgery, biopsy of a parenchymal organ, or significant trauma (including&#xD;
                  any trauma associated with the current AMI) within 3 months&#xD;
&#xD;
               -  History of stroke, transient ischaemic attack, or central nervous system&#xD;
                  structural damage (e.g. neoplasm, aneurysm, intracranial surgery)&#xD;
&#xD;
               -  Oral anticoagulation&#xD;
&#xD;
               -  Recent (within 10 days) non - compressible vascular puncture&#xD;
&#xD;
               -  Pregnancy (positive urine pregnancy test) or lactation, parturition within the&#xD;
                  previous 30 days, or female of childbearing potential not using adequate birth&#xD;
                  control (oral contraception)&#xD;
&#xD;
               -  Severe liver disease, including hepatic failure, cirrhosis portal hypertension&#xD;
                  (oesophageal varices) and active hepatitis&#xD;
&#xD;
               -  Diabetes with definite history of retinopathy&#xD;
&#xD;
               -  Other serious illness (e.g. malignancy, active infection)&#xD;
&#xD;
               -  Bacterial endocarditis / pericarditis&#xD;
&#xD;
               -  Acute pancreatitis&#xD;
&#xD;
               -  Documented ulcerative gastrointestinal disease during last 3 month, arterial&#xD;
                  aneurysms, arterial / venous malformations&#xD;
&#xD;
               -  Any other condition that the investigator feels would pose a significant hazard&#xD;
                  to the subject if the investigational therapy was to be initiated&#xD;
&#xD;
          -  Patients who are not excluded from thrombolytic therapy by the criteria above will, in&#xD;
             addition, need to satisfy the following 'inclusion' criteria prior to the pre -&#xD;
             hospital thrombolysis:&#xD;
&#xD;
               -  12 lead ECG criteria: ST segment elevation &gt;= 0.1 mV in two contiguous&#xD;
                  electrocardiogram (ECG) standard leads indicative of AMI, or ST elevation &gt;= 0.2&#xD;
                  mV in two contiguous chest leads and all left bundle branch block (LBBB) with&#xD;
                  clinical indication of AMI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 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>Tissue Plasminogen Activator</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/NCT02235389
org study id: 135.301
nct id: NCT02235389
lead sponsor: 
The general aim of this study was to assess the feasibility of treating acute myocardial
      infarction (AMI) by physician-directed pre-hospital thrombosis, using accelerated alteplase
      (Actilyse®) and a diagnostic technique involving remote electrocardiogram (ECG) acquisition
      by paramedics
observational model: Case-Control
time perspective: Prospective
measure: Percentage of equipment function / reliability
time frame: Up to 12 month after drug administration
measure: Time between pre-hospital evaluation and treatment
time frame: Up to 12 month after drug administration
measure: Percentage of acute myocardial infarction (AMI) patients, whose symptoms were recognized by paramedics
time frame: Up to 12 month after drug administration
measure: Percentage of patients correctly diagnosed as suffering acute myocardial infarction by remote ECG interpretation
time frame: Up to 12 month after drug administration
measure: Percentage of patients incorrectly diagnosed as suffering acute myocardial infarction by remote ECG interpretation
time frame: Up to 12 month after drug administration
measure: Percentage of patients receiving pre- hospital thrombolysis in the absence of a subsequently confirmed diagnosis of acute myocardial infarction
time frame: Up to 12 month after drug administration
measure: Percentage of patients giving consent to pre- hospital evaluation using remote electrocardiogram (ECG)
time frame: Up to 12 month after drug administration
measure: Number of patients with adverse events
time frame: Up to 12 month after drug administration
measure: Patient status at 30 days post myocardial infarction
time frame: Up to 30 days after drug administration
arm group label: Administration of thrombolytic treatment with PHARAOH
description: Pre-Hospital Alteplase Remote Advice of Hospital (PHARAOH)
arm group label: Standard therapy with thrombolytic treatment in Hospital
intervention type: Drug
intervention name: Alteplase (Actilyse)
arm group label: Administration of thrombolytic treatment with PHARAOH
intervention type: Drug
intervention name: Standard therapy
arm group label: Standard therapy with thrombolytic treatment in Hospital
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Tissue Plasminogen Activator