<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/NCT02972814</url>
  </required_header>
  <id_info>
    <org_study_id>16/093U</org_study_id>
    <nct_id>NCT02972814</nct_id>
  </id_info>
  <brief_title>Time Gain in the Diagnosis Myocardial Infarction by Troponin Point of Care Testing in the Emergency Room</brief_title>
  <acronym>T-POCT</acronym>
  <official_title>Time Gain in the Diagnosis of Non-ST Elevation Myocardial Infarction by Troponin Point of Care Testing in the Emergency Room</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ziekenhuis Oost-Limburg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ziekenhuis Oost-Limburg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators prospectively want to compare 3 clinical tests for measuring blood troponin&#xD;
      levels in patients presenting to the emergency room with thoracic pain probably related to a&#xD;
      myocardial infarction with regard to the time necessary to obtain the test results.&#xD;
&#xD;
      The tests are one laboratory based test and two point of care tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thoracic pain can be caused by a myocardial infarction. The diagnosis of a myocardial&#xD;
      infarction can be made by an ECG (ST-elevation myocardial infarction, STEMI). However, some&#xD;
      myocardial infarctions can also occur without ST-elevations on the ECG (non-ST-elevation&#xD;
      myocardial infarction, non-STEMI). In the latter case, a quick acquisition of blood troponin&#xD;
      levels is necessary to coin the diagnosis and initiate treatment. Therefore, the&#xD;
      investigators prospectively want to compare 3 clinical tests for measuring blood troponin&#xD;
      levels in patients presenting to the emergency room with thoracic pain probably related to a&#xD;
      non-STEMI with regard to the time necessary to obtain the test results.&#xD;
&#xD;
      The 3 tests are:&#xD;
&#xD;
        1. A laboratory based test: Roche Cobas E 602&#xD;
&#xD;
        2. A point of care test: Radiometer AQT 90 Flex&#xD;
&#xD;
        3. A point of care test: Philips Minicare I-20&#xD;
&#xD;
      The measured timeframe is the time between venipuncture to the point the test results are&#xD;
      known.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>time delay until troponin test results are known</measure>
    <time_frame>From the time of venipuncture to the time the troponin test results are known: up to 6 hours</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">66</enrollment>
  <condition>Non STEMI</condition>
  <condition>Angina Pectoris</condition>
  <condition>Angina, Stable</condition>
  <condition>Angina, Unstable</condition>
  <condition>Angina, Prinzmetal's</condition>
  <arm_group>
    <arm_group_label>Thoracic pain</arm_group_label>
    <description>Patients presenting to the emergency room with thoracic pain probably due to a non-STEMI</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laboratory based troponin test</intervention_name>
    <description>acquisition of blood troponin level by Roche Cobas E 603</description>
    <arm_group_label>Thoracic pain</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Point of care based troponin test 1</intervention_name>
    <description>acquisition of blood troponin level by Radiometer EQT 90 Flex</description>
    <arm_group_label>Thoracic pain</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Point of care based troponin test 2</intervention_name>
    <description>acquisition of blood troponin level by Philips Minicare I-20</description>
    <arm_group_label>Thoracic pain</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting to the emergency room with thoracic pain due to a non-STEMI&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Thoracic pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to give informed consent&#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>Pascal Vanelderen, MD, PhDD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Member of Staff</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg</name>
      <address>
        <city>Genk</city>
        <state>Limburg</state>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>April 20, 2021</last_update_submitted>
  <last_update_submitted_qc>April 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ziekenhuis Oost-Limburg</investigator_affiliation>
    <investigator_full_name>Pascal Vanelderen</investigator_full_name>
    <investigator_title>Prof. dr.</investigator_title>
  </responsible_party>
  <keyword>Troponin</keyword>
  <keyword>Point of care test</keyword>
  <keyword>myocardial infarction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Angina, Unstable</mesh_term>
    <mesh_term>Angina, Stable</mesh_term>
    <mesh_term>Angina Pectoris, Variant</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02972814
org study id: 16/093U
nct id: NCT02972814
lead sponsor: 
has dmc: No
The investigators prospectively want to compare 3 clinical tests for measuring blood troponin
      levels in patients presenting to the emergency room with thoracic pain probably related to a
      myocardial infarction with regard to the time necessary to obtain the test results.

      The tests are one laboratory based test and two point of care tests.
Thoracic pain can be caused by a myocardial infarction. The diagnosis of a myocardial
      infarction can be made by an ECG (ST-elevation myocardial infarction, STEMI). However, some
      myocardial infarctions can also occur without ST-elevations on the ECG (non-ST-elevation
      myocardial infarction, non-STEMI). In the latter case, a quick acquisition of blood troponin
      levels is necessary to coin the diagnosis and initiate treatment. Therefore, the
      investigators prospectively want to compare 3 clinical tests for measuring blood troponin
      levels in patients presenting to the emergency room with thoracic pain probably related to a
      non-STEMI with regard to the time necessary to obtain the test results.

      The 3 tests are:

        1. A laboratory based test: Roche Cobas E 602

        2. A point of care test: Radiometer AQT 90 Flex

        3. A point of care test: Philips Minicare I-20

      The measured timeframe is the time between venipuncture to the point the test results are
      known.
observational model: Cohort
time perspective: Prospective
measure: time delay until troponin test results are known
time frame: From the time of venipuncture to the time the troponin test results are known: up to 6 hours
arm group label: Thoracic pain
description: Patients presenting to the emergency room with thoracic pain probably due to a non-STEMI
intervention type: Device
intervention name: Laboratory based troponin test
description: acquisition of blood troponin level by Roche Cobas E 603
arm group label: Thoracic pain
intervention type: Device
intervention name: Point of care based troponin test 1
description: acquisition of blood troponin level by Radiometer EQT 90 Flex
arm group label: Thoracic pain
intervention type: Device
intervention name: Point of care based troponin test 2
description: acquisition of blood troponin level by Philips Minicare I-20
arm group label: Thoracic pain
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pascal Vanelderen, MD, PhDD
role: Principal Investigator
affiliation: Member of Staff
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Ziekenhuis Oost-Limburg
investigator full name: Pascal Vanelderen
investigator title: Prof. dr.
mesh term: Myocardial Infarction
mesh term: Angina Pectoris
mesh term: Angina, Unstable
mesh term: Angina, Stable
mesh term: Angina Pectoris, Variant
mesh term: Infarction
mesh term: Emergencies
sharing ipd: No