<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/NCT02984436</url>
  </required_header>
  <id_info>
    <org_study_id>STOP CP</org_study_id>
    <secondary_id>OCR15652</secondary_id>
    <secondary_id>20162880</secondary_id>
    <nct_id>NCT02984436</nct_id>
  </id_info>
  <brief_title>High-Sensitivity Cardiac Troponin T to OPtimize Chest Pain Risk Stratification</brief_title>
  <acronym>STOP CP</acronym>
  <official_title>High-Sensitivity Cardiac Troponin T to OPtimize Chest Pain Risk Stratification</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche Diagnostics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</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>
      This is a prospective observational cohort study of ED patients with acute chest pain or&#xD;
      other symptoms suggestive of ACS. Blood samples will be collected from study participants for&#xD;
      High-Sensitivity Cardiac Troponin T (hs-cTnT) analysis. Results from hs-cTnT will be used for&#xD;
      research purposes only.&#xD;
&#xD;
      Providers will be blinded to results and participants will be treated by their healthcare&#xD;
      providers per the standard of care. Participants will have 30 and 90 day phone follow-ups to&#xD;
      ascertain study outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 8 million - 10 million patients complaining of chest pain present to an&#xD;
      Emergency Department (ED) annually in the United States. To avoid missing the diagnosis of&#xD;
      acute coronary syndrome (ACS), physicians use a liberal testing strategy. Thus, &gt;50% of ED&#xD;
      patients with acute chest pain are hospitalized for a comprehensive cardiac evaluation&#xD;
      (serial cardiac biomarkers and stress testing or angiography). However, &lt;10% of these&#xD;
      patients are ultimately diagnosed with ACS, and this pervasive over-triage costs an estimated&#xD;
      $10 billion - $13 billion annually. Current care patterns for acute chest pain fail to focus&#xD;
      health system resources, such as hospitalization and stress testing, on patients most likely&#xD;
      to benefit.&#xD;
&#xD;
      It has demonstrated that an accelerated diagnostic protocol (ADP), called the HEART Pathway,&#xD;
      which utilizes a clinical decision aid (the HEART score) and serial Cardiac Troponin (cTn)&#xD;
      measures are sensitive for ACS (&gt;99%) and can substantially reduce hospitalizations, stress&#xD;
      testing, and cost compared to usual care. The HEART Pathway uses contemporary serial cTn&#xD;
      measurements at 0 and 3 hours to exclude index myocardial infarction (MI) and relies on&#xD;
      clinical features (history, ECG, age, and risk factors) to identify patients likely to have&#xD;
      downstream events. However, the HEART Pathway has limitations: a) It identifies only 20 - 40%&#xD;
      of patients for early discharge and b) it was developed before high-sensitivity cTn assays&#xD;
      became available. Able to detect MI earlier and with greater accuracy than contemporary&#xD;
      assays, hs-cTn assays have the potential to be integrated into decision aids to improve chest&#xD;
      pain risk stratification. In the near future, hs-cTn assays will replace contemporary assays&#xD;
      in the United States.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2017</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>High Sensitivity Cardiac Troponin T using lithium heparin tubes</measure>
    <time_frame>Baseline</time_frame>
    <description>The research team will obtain two lithium heparin tubes at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High Sensitivity Cardiac Troponin T using lithium heparin tubes</measure>
    <time_frame>1 hour after baseline</time_frame>
    <description>The research team will obtain two lithium heparin tubes at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High Sensitivity Cardiac Troponin T using lithium heparin tubes</measure>
    <time_frame>2 hours after baseline</time_frame>
    <description>The research team will obtain two lithium heparin tubes at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High Sensitivity Cardiac Troponin T using lithium heparin tubes</measure>
    <time_frame>3 hours after baseline</time_frame>
    <description>The research team will obtain two lithium heparin tubes at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High Sensitivity Cardiac Troponin T using EDTA tubes</measure>
    <time_frame>Baseline</time_frame>
    <description>The research team will obtain one EDTA tube at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High Sensitivity Cardiac Troponin T using EDTA tubes</measure>
    <time_frame>1 hour after baseline</time_frame>
    <description>The research team will obtain one EDTA tube at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High Sensitivity Cardiac Troponin T using EDTA tubes</measure>
    <time_frame>2 hours after baseline</time_frame>
    <description>The research team will obtain one EDTA tube at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High Sensitivity Cardiac Troponin T using EDTA tubes</measure>
    <time_frame>3 hours after baseline</time_frame>
    <description>The research team will obtain one EDTA tube at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiac Troponin T (cTn)</measure>
    <time_frame>Baseline</time_frame>
    <description>Site-specific cTn will be measured at baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiac Troponin T (cTn)</measure>
    <time_frame>3 hours</time_frame>
    <description>Site-specific cTn will be measured at 3 hours unless baseline site-specific cTn tests positive</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of major adverse cardiac events (MACE)</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of major adverse cardiac events (MACE)</measure>
    <time_frame>90 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>HEART Score Calculation</measure>
    <time_frame>Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge</time_frame>
    <description>By assigning zero, one, or two points - towards an atypical patient history, ECG anomalies, the patient's age, any risk factors present, and elevated Troponin - patients score on a scale of 0-10. 0-3 = Low-risk, 4 or greater = High-risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and Intensity of Adverse Events</measure>
    <time_frame>Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge</time_frame>
    <description>Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1572</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Chest Pain</condition>
  <arm_group>
    <arm_group_label>ED Patients with Acute Chest Pain</arm_group_label>
    <description>Emergency Department (ED) Patients with Acute Chest Pain will have blood samples collected for High sensitivity cardiac troponin T (hs-CTnT) analysis. Results from this analysis will be integrated into the HEART Score/Pathway. It will later be seen if integration of the hs-cTnT outperforms the use of HEART Score/Pathway alone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood Sample</intervention_name>
    <description>Blood samples will be collected from study participants for hs-cTnT analysis. Results of hs-cTnT will be used for research purposes only. Providers and participants will be blinded to results and participants will be treated by their healthcare providers per the standard of care.</description>
    <arm_group_label>ED Patients with Acute Chest Pain</arm_group_label>
    <other_name>Blood draw</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HEART Score</intervention_name>
    <description>The HEART Score is a prospectively studied scoring system to help emergency departments risk-stratify chest pain patients. Patients score on a scale of 0-10.</description>
    <arm_group_label>ED Patients with Acute Chest Pain</arm_group_label>
    <other_name>HEART Pathway</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients 21 years of age or older with possible Acute Coronary Syndrome (ACS) and&#xD;
        associated chest pain.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age greater than or equal to 21 years at the time of enrollment in the ED&#xD;
&#xD;
          2. Chest discomfort or other symptoms consistent with possible ACS in which the treating&#xD;
             physician plans to obtain an ECG and cTn for the patient's evaluation in the ED&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. New ST-segment elevation consistent with myocardial infarction&#xD;
&#xD;
          2. Evidence of shock identified by the provider at the bedside and/or the PI&#xD;
&#xD;
          3. Terminal diagnosis with life expectancy less than 90 days&#xD;
&#xD;
          4. A non-cardiac medical, surgical, or psychiatric illness determined by the provider to&#xD;
             require admission&#xD;
&#xD;
          5. Prior enrollment in the STOP CP study&#xD;
&#xD;
          6. Lack of capacity to provide consent and comply with study procedures&#xD;
&#xD;
          7. Inability to be reliably reached after the index visit for follow-up&#xD;
&#xD;
          8. Non-English speaking&#xD;
&#xD;
          9. Pregnant patients&#xD;
&#xD;
         10. Provider does not intend on obtaining serial cTn assays for evaluation of ACS&#xD;
&#xD;
         11. The first study draw (T0) will exceed 1 hour after the site-specific standard of care&#xD;
             troponin draw&#xD;
&#xD;
         12. Unable or unwilling to authorize medical records release&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brandon R Allen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>
    <facility>
      <name>Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 15, 2020</last_update_submitted>
  <last_update_submitted_qc>December 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2020</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>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Chest Pain</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/NCT02984436
org study id: STOP CP
secondary id: OCR15652
secondary id: 20162880
nct id: NCT02984436
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective observational cohort study of ED patients with acute chest pain or
      other symptoms suggestive of ACS. Blood samples will be collected from study participants for
      High-Sensitivity Cardiac Troponin T (hs-cTnT) analysis. Results from hs-cTnT will be used for
      research purposes only.

      Providers will be blinded to results and participants will be treated by their healthcare
      providers per the standard of care. Participants will have 30 and 90 day phone follow-ups to
      ascertain study outcomes.
Approximately 8 million - 10 million patients complaining of chest pain present to an
      Emergency Department (ED) annually in the United States. To avoid missing the diagnosis of
      acute coronary syndrome (ACS), physicians use a liberal testing strategy. Thus, >50% of ED
      patients with acute chest pain are hospitalized for a comprehensive cardiac evaluation
      (serial cardiac biomarkers and stress testing or angiography). However, <10% of these
      patients are ultimately diagnosed with ACS, and this pervasive over-triage costs an estimated
      $10 billion - $13 billion annually. Current care patterns for acute chest pain fail to focus
      health system resources, such as hospitalization and stress testing, on patients most likely
      to benefit.

      It has demonstrated that an accelerated diagnostic protocol (ADP), called the HEART Pathway,
      which utilizes a clinical decision aid (the HEART score) and serial Cardiac Troponin (cTn)
      measures are sensitive for ACS (>99%) and can substantially reduce hospitalizations, stress
      testing, and cost compared to usual care. The HEART Pathway uses contemporary serial cTn
      measurements at 0 and 3 hours to exclude index myocardial infarction (MI) and relies on
      clinical features (history, ECG, age, and risk factors) to identify patients likely to have
      downstream events. However, the HEART Pathway has limitations: a) It identifies only 20 - 40%
      of patients for early discharge and b) it was developed before high-sensitivity cTn assays
      became available. Able to detect MI earlier and with greater accuracy than contemporary
      assays, hs-cTn assays have the potential to be integrated into decision aids to improve chest
      pain risk stratification. In the near future, hs-cTn assays will replace contemporary assays
      in the United States.
observational model: Cohort
time perspective: Prospective
measure: High Sensitivity Cardiac Troponin T using lithium heparin tubes
time frame: Baseline
description: The research team will obtain two lithium heparin tubes at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.
measure: High Sensitivity Cardiac Troponin T using lithium heparin tubes
time frame: 1 hour after baseline
description: The research team will obtain two lithium heparin tubes at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.
measure: High Sensitivity Cardiac Troponin T using lithium heparin tubes
time frame: 2 hours after baseline
description: The research team will obtain two lithium heparin tubes at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.
measure: High Sensitivity Cardiac Troponin T using lithium heparin tubes
time frame: 3 hours after baseline
description: The research team will obtain two lithium heparin tubes at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.
measure: High Sensitivity Cardiac Troponin T using EDTA tubes
time frame: Baseline
description: The research team will obtain one EDTA tube at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.
measure: High Sensitivity Cardiac Troponin T using EDTA tubes
time frame: 1 hour after baseline
description: The research team will obtain one EDTA tube at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.
measure: High Sensitivity Cardiac Troponin T using EDTA tubes
time frame: 2 hours after baseline
description: The research team will obtain one EDTA tube at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.
measure: High Sensitivity Cardiac Troponin T using EDTA tubes
time frame: 3 hours after baseline
description: The research team will obtain one EDTA tube at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.
measure: Cardiac Troponin T (cTn)
time frame: Baseline
description: Site-specific cTn will be measured at baseline
measure: Cardiac Troponin T (cTn)
time frame: 3 hours
description: Site-specific cTn will be measured at 3 hours unless baseline site-specific cTn tests positive
measure: Occurrence of major adverse cardiac events (MACE)
time frame: 30 days
measure: Occurrence of major adverse cardiac events (MACE)
time frame: 90 days
measure: HEART Score Calculation
time frame: Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge
description: By assigning zero, one, or two points - towards an atypical patient history, ECG anomalies, the patient's age, any risk factors present, and elevated Troponin - patients score on a scale of 0-10. 0-3 = Low-risk, 4 or greater = High-risk
measure: Incidence and Intensity of Adverse Events
time frame: Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge
description: Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0
arm group label: ED Patients with Acute Chest Pain
description: Emergency Department (ED) Patients with Acute Chest Pain will have blood samples collected for High sensitivity cardiac troponin T (hs-CTnT) analysis. Results from this analysis will be integrated into the HEART Score/Pathway. It will later be seen if integration of the hs-cTnT outperforms the use of HEART Score/Pathway alone.
intervention type: Procedure
intervention name: Blood Sample
description: Blood samples will be collected from study participants for hs-cTnT analysis. Results of hs-cTnT will be used for research purposes only. Providers and participants will be blinded to results and participants will be treated by their healthcare providers per the standard of care.
arm group label: ED Patients with Acute Chest Pain
other name: Blood draw
intervention type: Behavioral
intervention name: HEART Score
description: The HEART Score is a prospectively studied scoring system to help emergency departments risk-stratify chest pain patients. Patients score on a scale of 0-10.
arm group label: ED Patients with Acute Chest Pain
other name: HEART Pathway
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Brandon R Allen, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Chest Pain
sharing ipd: No