<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/NCT04488913</url>
  </required_header>
  <id_info>
    <org_study_id>pending</org_study_id>
    <nct_id>NCT04488913</nct_id>
  </id_info>
  <brief_title>Rapid Acute Coronary Syndrome Exclusion Using High-sensitivity I Troponin</brief_title>
  <acronym>RACE-IT</acronym>
  <official_title>Rapid Acute Coronary Syndrome Exclusion Using the Beckman Coulter Access High-sensitivity I Troponin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beckman Coulter, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Henry Ford Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      As part of the planned implementation of a new clinical pathway using hs-cTnI, the&#xD;
      investigators will measure patient outcomes and clinical processes in a real-world scenario&#xD;
      throughout an integrated health system across 9 emergency departments (ED).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pragmatic, implementation study testing the implications of a real-world execution&#xD;
      of a rapid evaluation pathway for suspected ACS using the Beckman hs-cTnI assay. As the new&#xD;
      protocol is executed across 9 EDs within an integrated health system, the investigators will&#xD;
      study its effects on patient and system-level metrics. A modified stepped wedge design will&#xD;
      be utilized that allows comparison of the RACE-IT pathway with standard of care management&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 29, 2020</start_date>
  <completion_date type="Actual">March 3, 2022</completion_date>
  <primary_completion_date type="Actual">April 3, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Stepped-Wedge Cluster Randomized</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safe ED discharge</measure>
    <time_frame>30 days after initial presentation</time_frame>
    <description>Proportion of patients with safe discharges home from the ED, defined as being without death or acute myocardial infarction within 30-days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>From date and time of start of emergency department encounter until date and time of end of ED or hospital encounter (whichever is latest), assessed up to 7 days.</time_frame>
    <description>Length of time from initial presentation to the Emergency Department until final discharge from the Emergency Department or Observation Unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with death or acute myocardial infarction</measure>
    <time_frame>30-day and through 1 year</time_frame>
    <description>Death or presence of acute myocardial infarction determined by adjudication panel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with revascularization or rehospitalization for cardiovascular disease</measure>
    <time_frame>30-days</time_frame>
    <description>revascularization includes percutaneous coronary interventions and rehospitalization is inclusive of any such event for acute heart failure, acute myocardial infarction, or arrhythmia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite number of cardiology resources utilized</measure>
    <time_frame>30-days</time_frame>
    <description>Cardiology resources are inclusive of completed orders for cardiac stress tests, cardiology consultation, coronary computed tomography, coronary angiography, and percutaneous coronary intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital payments received</measure>
    <time_frame>30-days</time_frame>
    <description>The total hospital payments received for the initial ED visit and any subsequent hospitalizations and procedures that are cardiology related over 30-days from the initial encounter.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pre-specified sub-group analyses of the primary outcome</measure>
    <time_frame>30 days</time_frame>
    <description>We will explore analysis assessing gender-specific cut-points for hs-cTnI associated with safe discharge</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32609</enrollment>
  <condition>Chest Pain</condition>
  <condition>Myocardial Ischemia</condition>
  <arm_group>
    <arm_group_label>Standard of Care Treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Exposure to traditional evaluation for suspected acute coronary syndrome (ACS) with ECG, 0- and 3-hour troponin testing using the 99th percentile as the upper reference limit, and application of the History, EKG, Age, Risk factors, and troponin (HEART) score.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RACE-IT pathway</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exposure to new protocol for suspected ACS, which includes the use of 0- and 1-hour ECG and high-sensitivity troponin testing and application of the HEAR score (a modification of the HEART score)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>RACE-IT Pathway</intervention_name>
    <description>This care pathway includes the evaluation of suspected acute coronary syndrome with high-sensitivity troponin I testing and further prognostication as needed with a modified HEART score</description>
    <arm_group_label>RACE-IT pathway</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Standard of care protocol that uses the 99th percentile troponin values for evaluation of suspected acute coronary syndrome and further prognostication using the HEART score</description>
    <arm_group_label>Standard of Care Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥18 years old presenting to the ED for whom a treating clinician suspects ACS&#xD;
             and orders a baseline ECG and cardiac troponin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. ST-segment Myocardial Infarction (STEMI) leading to immediate reperfusion therapy&#xD;
&#xD;
          2. Any ED-drawn hs-cTnI value &gt; 99th percentile (18 ng/L)&#xD;
&#xD;
          3. Clear traumatic cause for symptoms (e.g., direct chest wall trauma, motor vehicle&#xD;
             accident)&#xD;
&#xD;
          4. A transfer from another facility&#xD;
&#xD;
          5. Primary residence outside the state of Michigan&#xD;
&#xD;
          6. Previous inclusion in the study&#xD;
&#xD;
          7. Enrolled in hospice&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>March 21, 2022</last_update_submitted>
  <last_update_submitted_qc>March 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Joseph Miller, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>high-sensitivity troponin</keyword>
  <keyword>chest pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Ischemia</mesh_term>
    <mesh_term>Chest Pain</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/NCT04488913
org study id: pending
nct id: NCT04488913
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
As part of the planned implementation of a new clinical pathway using hs-cTnI, the
      investigators will measure patient outcomes and clinical processes in a real-world scenario
      throughout an integrated health system across 9 emergency departments (ED).
This is a pragmatic, implementation study testing the implications of a real-world execution
      of a rapid evaluation pathway for suspected ACS using the Beckman hs-cTnI assay. As the new
      protocol is executed across 9 EDs within an integrated health system, the investigators will
      study its effects on patient and system-level metrics. A modified stepped wedge design will
      be utilized that allows comparison of the RACE-IT pathway with standard of care management
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Stepped-Wedge Cluster Randomized
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Safe ED discharge
time frame: 30 days after initial presentation
description: Proportion of patients with safe discharges home from the ED, defined as being without death or acute myocardial infarction within 30-days
measure: Length of hospital stay
time frame: From date and time of start of emergency department encounter until date and time of end of ED or hospital encounter (whichever is latest), assessed up to 7 days.
description: Length of time from initial presentation to the Emergency Department until final discharge from the Emergency Department or Observation Unit
measure: Number of participants with death or acute myocardial infarction
time frame: 30-day and through 1 year
description: Death or presence of acute myocardial infarction determined by adjudication panel
measure: Number of participants with revascularization or rehospitalization for cardiovascular disease
time frame: 30-days
description: revascularization includes percutaneous coronary interventions and rehospitalization is inclusive of any such event for acute heart failure, acute myocardial infarction, or arrhythmia
measure: Composite number of cardiology resources utilized
time frame: 30-days
description: Cardiology resources are inclusive of completed orders for cardiac stress tests, cardiology consultation, coronary computed tomography, coronary angiography, and percutaneous coronary intervention
measure: Hospital payments received
time frame: 30-days
description: The total hospital payments received for the initial ED visit and any subsequent hospitalizations and procedures that are cardiology related over 30-days from the initial encounter.
measure: Pre-specified sub-group analyses of the primary outcome
time frame: 30 days
description: We will explore analysis assessing gender-specific cut-points for hs-cTnI associated with safe discharge
arm group label: Standard of Care Treatment
arm group type: Other
description: Exposure to traditional evaluation for suspected acute coronary syndrome (ACS) with ECG, 0- and 3-hour troponin testing using the 99th percentile as the upper reference limit, and application of the History, EKG, Age, Risk factors, and troponin (HEART) score.
arm group label: RACE-IT pathway
arm group type: Active Comparator
description: Exposure to new protocol for suspected ACS, which includes the use of 0- and 1-hour ECG and high-sensitivity troponin testing and application of the HEAR score (a modification of the HEART score)
intervention type: Other
intervention name: RACE-IT Pathway
description: This care pathway includes the evaluation of suspected acute coronary syndrome with high-sensitivity troponin I testing and further prognostication as needed with a modified HEART score
arm group label: RACE-IT pathway
intervention type: Other
intervention name: Standard of Care
description: Standard of care protocol that uses the 99th percentile troponin values for evaluation of suspected acute coronary syndrome and further prognostication using the HEART score
arm group label: Standard of Care Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Joseph Miller, MD
investigator title: Principal Investigator
mesh term: Acute Coronary Syndrome
mesh term: Myocardial Ischemia
mesh term: Hypersensitivity
mesh term: Ischemia
mesh term: Chest Pain