<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/NCT01665521</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00021074</org_study_id>
    <secondary_id>12CRP12000001</secondary_id>
    <nct_id>NCT01665521</nct_id>
  </id_info>
  <brief_title>Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain</brief_title>
  <acronym>HEART Pathway</acronym>
  <official_title>Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Heart Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Our research will examine a chest pain care strategy, called the HEART pathway, which is&#xD;
      designed to correctly identify Emergency Department patients at high-risk for cardiovascular&#xD;
      events, likely to benefit from further testing, and patients at very-low-risk for&#xD;
      cardiovascular events, who may be safely discharged home. By using an individual's risk&#xD;
      assessment to determining testing, we hope to improve the quality and efficiency of the care&#xD;
      delivered to Emergency Department patients with chest pain. Our study will determine if the&#xD;
      HEART pathway, which combines a clinical decision rule, the HEART score, and two serial&#xD;
      troponin measurements, will reduce stress testing and cardiovascular imaging, decrease&#xD;
      hospital length of stay, and reduce cost compared to usual care, while maintaining safety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 8-10 million patients complaining of chest pain present to an Emergency&#xD;
      Department (ED) annually in the United States. The total cost of chest pain evaluations has&#xD;
      been estimated at $5-10 billion annually, yet only 10% of these patients are ultimately&#xD;
      diagnosed with an acute coronary syndrome. American College of Cardiology/ American Heart&#xD;
      Association (ACC/AHA) guidelines recommend that patients at low-risk for acute coronary&#xD;
      syndrome should receive serial cardiac markers followed by objective cardiac testing (stress&#xD;
      testing or cardiac imaging). However, many have questioned the value of objective cardiac&#xD;
      testing in all low-risk patients.Cardiac testing for all patients at low-risk for acute&#xD;
      coronary syndrome (ACS) is not sustainable from a healthcare quality or economic perspective.&#xD;
      In addition to increasing costs, objective cardiac testing is associated with a substantial&#xD;
      number of false positive and non-diagnostic tests, which lead to additional unnecessary and&#xD;
      often invasive procedures.&#xD;
&#xD;
      Implementation of accurate risk stratification care pathways designed to eliminate&#xD;
      unnecessary cardiac testing could improve the efficiency and quality of care by decreasing&#xD;
      false positive/non-diagnostic testing, radiation, and costs. The HEART pathway, which&#xD;
      combines a clinical decision rule, the HEART score, and two serial troponin measurements, is&#xD;
      a recently developed care pathway designed to identify chest pain patients for early&#xD;
      discharge without objective testing.&#xD;
&#xD;
      Primary Hypothesis: The HEART Pathway, when compared to usual care, will reduce 30 day&#xD;
      objective cardiac testing, hospital length of stay, and cost, while maintaining patient&#xD;
      safety.&#xD;
&#xD;
      Methods: Participants (n=282) at risk for ACS will be recruited into a clinical trial from&#xD;
      Wake Forest Baptist Medical Center (WFBMC) ED. Patients will be equally randomized to HEART&#xD;
      Pathway or Usual Care. HEART Pathway participant's treating physician will follow HEART&#xD;
      Pathway guidelines for identifying patients to be admitted to the hospital or observation&#xD;
      unit for cardiac testing or to be discharged home without testing. Usual Care participant's&#xD;
      treating physicians will decide whether the patients should be discharged home or admitted to&#xD;
      the hospital or observation unit based on ACC/AHA guidelines without using the HEART pathway.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">January 15, 2018</completion_date>
  <primary_completion_date type="Actual">February 20, 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective cardiac testing (stress testing or cardiac imaging) within 30 days</measure>
    <time_frame>30 Days</time_frame>
    <description>Rate of objective cardiac testing within 30 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost, length of stay, recurrent ED visits and non-index hospitalization for chest pain.</measure>
    <time_frame>30 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective cardiac testing (stress testing or cardiac imaging), cost, length of stay, and recurrent ED visits and non-index hospitalization for chest pain.</measure>
    <time_frame>1 Year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Index objective cardiac testing rate</measure>
    <time_frame>Duration of Index Hospitalization, average of 1 to 2 days</time_frame>
    <description>proportion of patients receiving any stress testing modality, coronary computed tomography angiography, or invasive catheter angiography at the index visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Index Hospital Admission Rate</measure>
    <time_frame>Duration of Index Hospitalization, average of 1 to 2 days</time_frame>
    <description>Proportion of patients hospitalized for admission or observation during the index visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early discharge rate</measure>
    <time_frame>Duration of Index Hospitalization, average of 1 to 2 days</time_frame>
    <description>Proportion of patients that are discharged from the Emergency Department without meeting the composite endpoint of index hospital admission or index objective cardiac testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite of 30 day hospital admission and objective cardiac testing</measure>
    <time_frame>30 Days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Major adverse cardiac events (MACE)</measure>
    <time_frame>30 Days and 1 Year</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Missed MACE</measure>
    <time_frame>30 Days and 1 Year</time_frame>
    <description>MACE occurring in patients discharged without objective cardiac testing.</description>
  </other_outcome>
  <other_outcome>
    <measure>Provider adherence to the HEART Pathway</measure>
    <time_frame>Duration of Index Hospitalization, average of 1 to 2 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Inter-rater reliability of the HEART Pathway</measure>
    <time_frame>Duration of the Index ED visit, less than 1 day</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">282</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Chest Pain</condition>
  <arm_group>
    <arm_group_label>HEART Pathway</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The HEART Pathway will be used for real time clinical decision making. Physicians will receive care recommendations according to the HEART Pathway, based on HEART score and serial cardiac biomarkers. This will help physicians identify low-risk patients for early discharge with no objective cardiac testing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Conventional Care cardiac testing. Patients will undergo cardiac testing as determined by their treating physicians.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HEART Pathway</intervention_name>
    <description>During ED evaluation, patients are randomized to HEART Pathway or usual care arms.</description>
    <arm_group_label>HEART Pathway</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 21 years&#xD;
&#xD;
          -  Chest discomfort or other symptoms consistent with possible ACS&#xD;
&#xD;
          -  The treating physician feels the patient could be discharged home if cardiac disease&#xD;
             was excluded&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  New ST-segment elevation in contiguous leads on any electrocardiogram (&gt;/= 1 mV)&#xD;
&#xD;
          -  Unstable vitals signs: symptomatic hypotension at the time of enrollment (systolic &lt;&#xD;
             90 mm Hg), tachycardia (HR&gt;120), bradycardia (HR&lt;40), and hypoxemia (&lt;90%&#xD;
             pulse-oximetry on room air or normal home oxygen flow rate)&#xD;
&#xD;
          -  Terminal diagnosis with life expectancy less than 1 year&#xD;
&#xD;
          -  A non-cardiac medical, surgical, or psychiatric illness determined by the provider to&#xD;
             require admission, increase risk of objective cardiac testing, or prevent immediate&#xD;
             discharge following negative testing.&#xD;
&#xD;
          -  Prior enrollment&#xD;
&#xD;
          -  Incapacity or unwillingness to provide consent and comply with study procedures&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
        Sub-study I &amp; II&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  ED attending physicians&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ED attending physicians who decline to participate&#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>Simon A Mahler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest Baptist Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest Wake Forest University Baptist Medical Center - Emergency Department</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.wakehealth.edu</url>
    <description>Wake Forest Baptist Health</description>
  </link>
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  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>March 3, 2022</last_update_submitted>
  <last_update_submitted_qc>March 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute Coronary Syndrome</keyword>
  <keyword>Chest pain</keyword>
  <keyword>Risk Stratification</keyword>
  <keyword>HEART Pathway</keyword>
  <keyword>Emergency Department</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Emergencies</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/NCT01665521
org study id: IRB00021074
secondary id: 12CRP12000001
nct id: NCT01665521
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Our research will examine a chest pain care strategy, called the HEART pathway, which is
      designed to correctly identify Emergency Department patients at high-risk for cardiovascular
      events, likely to benefit from further testing, and patients at very-low-risk for
      cardiovascular events, who may be safely discharged home. By using an individual's risk
      assessment to determining testing, we hope to improve the quality and efficiency of the care
      delivered to Emergency Department patients with chest pain. Our study will determine if the
      HEART pathway, which combines a clinical decision rule, the HEART score, and two serial
      troponin measurements, will reduce stress testing and cardiovascular imaging, decrease
      hospital length of stay, and reduce cost compared to usual care, while maintaining safety.
Approximately 8-10 million patients complaining of chest pain present to an Emergency
      Department (ED) annually in the United States. The total cost of chest pain evaluations has
      been estimated at $5-10 billion annually, yet only 10% of these patients are ultimately
      diagnosed with an acute coronary syndrome. American College of Cardiology/ American Heart
      Association (ACC/AHA) guidelines recommend that patients at low-risk for acute coronary
      syndrome should receive serial cardiac markers followed by objective cardiac testing (stress
      testing or cardiac imaging). However, many have questioned the value of objective cardiac
      testing in all low-risk patients.Cardiac testing for all patients at low-risk for acute
      coronary syndrome (ACS) is not sustainable from a healthcare quality or economic perspective.
      In addition to increasing costs, objective cardiac testing is associated with a substantial
      number of false positive and non-diagnostic tests, which lead to additional unnecessary and
      often invasive procedures.

      Implementation of accurate risk stratification care pathways designed to eliminate
      unnecessary cardiac testing could improve the efficiency and quality of care by decreasing
      false positive/non-diagnostic testing, radiation, and costs. The HEART pathway, which
      combines a clinical decision rule, the HEART score, and two serial troponin measurements, is
      a recently developed care pathway designed to identify chest pain patients for early
      discharge without objective testing.

      Primary Hypothesis: The HEART Pathway, when compared to usual care, will reduce 30 day
      objective cardiac testing, hospital length of stay, and cost, while maintaining patient
      safety.

      Methods: Participants (n=282) at risk for ACS will be recruited into a clinical trial from
      Wake Forest Baptist Medical Center (WFBMC) ED. Patients will be equally randomized to HEART
      Pathway or Usual Care. HEART Pathway participant's treating physician will follow HEART
      Pathway guidelines for identifying patients to be admitted to the hospital or observation
      unit for cardiac testing or to be discharged home without testing. Usual Care participant's
      treating physicians will decide whether the patients should be discharged home or admitted to
      the hospital or observation unit based on ACC/AHA guidelines without using the HEART pathway.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Objective cardiac testing (stress testing or cardiac imaging) within 30 days
time frame: 30 Days
description: Rate of objective cardiac testing within 30 days
measure: Cost, length of stay, recurrent ED visits and non-index hospitalization for chest pain.
time frame: 30 Days
measure: Objective cardiac testing (stress testing or cardiac imaging), cost, length of stay, and recurrent ED visits and non-index hospitalization for chest pain.
time frame: 1 Year
measure: Index objective cardiac testing rate
time frame: Duration of Index Hospitalization, average of 1 to 2 days
description: proportion of patients receiving any stress testing modality, coronary computed tomography angiography, or invasive catheter angiography at the index visit
measure: Index Hospital Admission Rate
time frame: Duration of Index Hospitalization, average of 1 to 2 days
description: Proportion of patients hospitalized for admission or observation during the index visit
measure: Early discharge rate
time frame: Duration of Index Hospitalization, average of 1 to 2 days
description: Proportion of patients that are discharged from the Emergency Department without meeting the composite endpoint of index hospital admission or index objective cardiac testing
measure: Composite of 30 day hospital admission and objective cardiac testing
time frame: 30 Days
measure: Major adverse cardiac events (MACE)
time frame: 30 Days and 1 Year
measure: Missed MACE
time frame: 30 Days and 1 Year
description: MACE occurring in patients discharged without objective cardiac testing.
measure: Provider adherence to the HEART Pathway
time frame: Duration of Index Hospitalization, average of 1 to 2 days
measure: Inter-rater reliability of the HEART Pathway
time frame: Duration of the Index ED visit, less than 1 day
arm group label: HEART Pathway
arm group type: Experimental
description: The HEART Pathway will be used for real time clinical decision making. Physicians will receive care recommendations according to the HEART Pathway, based on HEART score and serial cardiac biomarkers. This will help physicians identify low-risk patients for early discharge with no objective cardiac testing.
arm group label: Usual Care
arm group type: No Intervention
description: Conventional Care cardiac testing. Patients will undergo cardiac testing as determined by their treating physicians.
intervention type: Other
intervention name: HEART Pathway
description: During ED evaluation, patients are randomized to HEART Pathway or usual care arms.
arm group label: HEART Pathway
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Simon A Mahler, MD
role: Principal Investigator
affiliation: Wake Forest Baptist Medical Center
facility: 
country: United States
url: http://www.wakehealth.edu
description: Wake Forest Baptist Health
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responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Emergencies
mesh term: Chest Pain