<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/NCT02983123</url>
  </required_header>
  <id_info>
    <org_study_id>2016/1241/REK</org_study_id>
    <secondary_id>2016/13308</secondary_id>
    <nct_id>NCT02983123</nct_id>
  </id_info>
  <brief_title>One-hour Troponin in a Low-prevalence Population of Acute Coronary Syndrome</brief_title>
  <acronym>OUT-ACS</acronym>
  <official_title>Introduction of an 1-hour Algorithm for High-sensitivity Cardiac-specific Troponin T for Faster Assessment of NSTEMI in a Low-prevalence Population at Oslo Accident and Emergency Outpatient Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate if the 1-hour rule-in/rule-out algorithm for a high-sensitivity&#xD;
      cardiac troponin T (hs-cTnT) is safe and effective for use in the primary care where the&#xD;
      patients have a lower pretest probability of an acute myocardial infarction (MI). During this&#xD;
      study troponins will be collected at 0-, 1- and 4/6-hours, where absolute changes in the&#xD;
      values will decide whether the patient need hospitalization or not.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many patients seek Oslo Accident and Emergency Outpatient Clinic (OAEOC) with chest pain. The&#xD;
      majority of these patients have symptoms suggestive of a benign non-cardiac chest pain. These&#xD;
      patients do not need a directly transfer to the hospital, but can be admitted to the&#xD;
      Observation Unit at the OAEOC for further pre-hospital testing, including serial troponins&#xD;
      for a safe rule-out of acute MI. The main goal of this study is to improve the current&#xD;
      routine at the Observation Unit at OAEOC by introducing the 1-hour algorithm for hs-cTnT for&#xD;
      a faster rule-in/rule-out of acute MI.&#xD;
&#xD;
      All recruited patients will have serial troponins drawn at 0, 1- and 4/6 hours, with the main&#xD;
      hypothesis that the absolute changes within 1 hour can be used as surrogates for the changes&#xD;
      and conclusions drawn after 4/6 hours. The cut-off levels used within the 0/1-hour algorithm&#xD;
      are assay specific as specified in the 2015 European Society of Cardiology Guidelines for the&#xD;
      management of acute NSTEMI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2016</start_date>
  <completion_date type="Actual">October 22, 2018</completion_date>
  <primary_completion_date type="Actual">October 22, 2018</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>Number of patients transferred to the hospital (rule-in) according to the 1-hour algorithm</measure>
    <time_frame>7-10 hours</time_frame>
    <description>The troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients without significant changes (rule-out) according to the 1-hour algorithm</measure>
    <time_frame>7-10 hours</time_frame>
    <description>The troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with significant change in the 3rd troponin (drawn after 4-6 hours) who were not identified by the 1-hour algorithm</measure>
    <time_frame>10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Significant changes between the first and second ECG?</measure>
    <time_frame>6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with NSTEMI admitted to the hospital from the Observation Unit at the OAEOC</measure>
    <time_frame>1 week</time_frame>
    <description>The final diagnosis will be collected from all patients who were admitted to the hospital from the Observation Unit during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90 days follow-up of all recruited patients</measure>
    <time_frame>90 days</time_frame>
    <description>How many will have an acute MI the next 3 months?</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1750</enrollment>
  <condition>Non-ST Elevation Myocardial Infarction</condition>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Angina, Unstable</condition>
  <condition>NSTEMI - Non-ST Segment Elevation MI</condition>
  <arm_group>
    <arm_group_label>1 hour-troponin</arm_group_label>
    <description>1-hour troponin collected of all recruited patients in addition to the daily routine with serial troponins collected at 0- and 4/6 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>1-hour hs-cTnT</intervention_name>
    <arm_group_label>1 hour-troponin</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting to the Oslo Accident and Emergency Outpatient Clinic with symptoms&#xD;
        suggestive of a benign non-cardiac chest pain, who needs further pre-hospital testing at&#xD;
        the Observation Unit for a safe rule-out of an acute MI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients at the outpatient clinic with suspected non-cardiac chest pain/symptoms who&#xD;
             need further testing for a safe rule-out of an acute MI&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute STEMI (ST-elevation myocardial infarction) (directly to the hospital)&#xD;
&#xD;
          -  Strong suspicion of an acute NSTEMI/unstable angina (directly to the hospital)&#xD;
&#xD;
          -  Terminal kidney disease with a glomerular filtration rate (GFR) &lt; 30&#xD;
&#xD;
          -  Unable to communicate in Norwegian, Swedish, Danish or English language&#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>Dan Atar, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Oslo University Hospital and University of Oslo, Norway</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo Accident and Emergency Outpatient Clinic</name>
      <address>
        <city>Oslo</city>
        <zip>0182</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Dan Atar</investigator_full_name>
    <investigator_title>Professor of Cardiology and Head of Research</investigator_title>
  </responsible_party>
  <keyword>Acute MI</keyword>
  <keyword>Acute myocardial infarction cardiac troponin</keyword>
  <keyword>High-sensitivity cardiac troponin T</keyword>
  <keyword>0/1-hour algorithm</keyword>
  <keyword>Outpatient clinic</keyword>
  <keyword>Cardiac troponin</keyword>
  <keyword>Chest pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Non-ST Elevated Myocardial Infarction</mesh_term>
    <mesh_term>Angina, Unstable</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Infarction</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/NCT02983123
org study id: 2016/1241/REK
secondary id: 2016/13308
nct id: NCT02983123
lead sponsor: 
collaborator: 
has dmc: No
This study aims to evaluate if the 1-hour rule-in/rule-out algorithm for a high-sensitivity
      cardiac troponin T (hs-cTnT) is safe and effective for use in the primary care where the
      patients have a lower pretest probability of an acute myocardial infarction (MI). During this
      study troponins will be collected at 0-, 1- and 4/6-hours, where absolute changes in the
      values will decide whether the patient need hospitalization or not.
Many patients seek Oslo Accident and Emergency Outpatient Clinic (OAEOC) with chest pain. The
      majority of these patients have symptoms suggestive of a benign non-cardiac chest pain. These
      patients do not need a directly transfer to the hospital, but can be admitted to the
      Observation Unit at the OAEOC for further pre-hospital testing, including serial troponins
      for a safe rule-out of acute MI. The main goal of this study is to improve the current
      routine at the Observation Unit at OAEOC by introducing the 1-hour algorithm for hs-cTnT for
      a faster rule-in/rule-out of acute MI.

      All recruited patients will have serial troponins drawn at 0, 1- and 4/6 hours, with the main
      hypothesis that the absolute changes within 1 hour can be used as surrogates for the changes
      and conclusions drawn after 4/6 hours. The cut-off levels used within the 0/1-hour algorithm
      are assay specific as specified in the 2015 European Society of Cardiology Guidelines for the
      management of acute NSTEMI.
observational model: Cohort
time perspective: Prospective
measure: Number of patients transferred to the hospital (rule-in) according to the 1-hour algorithm
time frame: 7-10 hours
description: The troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.
measure: Number of patients without significant changes (rule-out) according to the 1-hour algorithm
time frame: 7-10 hours
description: The troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.
measure: Number of patients with significant change in the 3rd troponin (drawn after 4-6 hours) who were not identified by the 1-hour algorithm
time frame: 10 hours
measure: Significant changes between the first and second ECG?
time frame: 6 hours
measure: Number of patients with NSTEMI admitted to the hospital from the Observation Unit at the OAEOC
time frame: 1 week
description: The final diagnosis will be collected from all patients who were admitted to the hospital from the Observation Unit during the study
measure: 90 days follow-up of all recruited patients
time frame: 90 days
description: How many will have an acute MI the next 3 months?
arm group label: 1 hour-troponin
description: 1-hour troponin collected of all recruited patients in addition to the daily routine with serial troponins collected at 0- and 4/6 hours.
intervention type: Procedure
intervention name: 1-hour hs-cTnT
arm group label: 1 hour-troponin
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dan Atar, MD, PhD
role: Study Director
affiliation: Oslo University Hospital and University of Oslo, Norway
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Dan Atar
investigator title: Professor of Cardiology and Head of Research
mesh term: Myocardial Infarction
mesh term: Acute Coronary Syndrome
mesh term: Non-ST Elevated Myocardial Infarction
mesh term: Angina, Unstable
mesh term: Syndrome
mesh term: Infarction
sharing ipd: No