<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/NCT01703156</url>
  </required_header>
  <id_info>
    <org_study_id>Low Risk ACS</org_study_id>
    <secondary_id>IRB#14542</secondary_id>
    <nct_id>NCT01703156</nct_id>
  </id_info>
  <brief_title>Low Risk Acute Coronary Syndrome</brief_title>
  <acronym>LOW ACT</acronym>
  <official_title>Stress Testing Versus Non-Stress Testing Based Strategy in Patients Hospitalized With Low-Risk Acute Coronary Syndromes: A Randomized, Single-Center Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oklahoma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A large number of patients are diagnosed with low risk ACS, and these individuals are at&#xD;
      significant cardiovascular risk. Though guidelines recommend stress testing to manage low&#xD;
      risk ACS patients, evidence supporting this recommendation is not based on trials examining&#xD;
      this population. A well-designed, randomized trial is warranted to determine if stress&#xD;
      testing is useful in managing low risk ACS. If medical therapy alone is equivalent as the&#xD;
      investigators hypothesize, healthcare expenditures could be reduced and patients may not be&#xD;
      exposed to the harms associated with more invasive cardiac testing such as coronary&#xD;
      angiography.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite of all-cause mortality, hospitalization for UA/NSTEMI or STEMI, and urgent revascularization</measure>
    <time_frame>one year</time_frame>
    <description>Primary endpoints include the composite of all-cause mortality, hospitalization for Unstable Angina/Non ST-Elevation Myocardial Infarction (UA/NSTEMI) or ST-Elevation Myocardial Infarction (STEMI), and urgent revascularization (coronary artery bypass grafting or percutaneous coronary intervention).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary endpoints will include mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects.</measure>
    <time_frame>one year</time_frame>
    <description>Secondary endpoints will include: mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Low Risk Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>Non-Stress Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Medical therapy will be implemented and will include the following: aspirin, clopidogrel, b-blockers, and statins. The dosages of aspirin, b-blocker and statin will be left to the discretion of the treating physician. Statins will be initiated irrespective of LDL unless contraindicated. Clopidogrel will be taken for at least one month and ideally up to one year. Sublingual nitroglycerin will be provided to all patients. Other anti-ischemic medications including long-acting nitrates, calcium channel blockers, and ranolazine may be provided at the treating physicians' discretion. If a patient has contraindications to any medications, they will not be administered. If a statin contraindication exists, other cholesterol-lowering medications may be administered. Appendix 4 shows the detailed management of low risk ACS patients randomized to the non-stress group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stress Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medical therapy will be implemented and will include the following: aspirin, clopidogrel, b-blockers, and statins. Statins will be initiated irrespective of LDL unless contraindicated. Clopidogrel will be taken for at least one month and ideally up to one year. Sublingual nitroglycerin will be provided to all patients. Other anti-ischemic medications including long-acting nitrates, calcium channel blockers, and ranolazine may be provided at the treating physicians' discretion. If a statin contraindication exists, other cholesterol-lowering medications may be administered. All patients will undergo noninvasive stress testing. Results of individual stress tests will be reviewed by a cardiologist. Based on the myocardium deemed at risk and patient symptoms, further testing with angiography and revascularization using percutaneous techniques and/or coronary artery bypass grafting may be considered. Likewise, medical treatment may be adjusted.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stress Test</intervention_name>
    <arm_group_label>Stress Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No Stress Test</intervention_name>
    <arm_group_label>Non-Stress Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. TIMI score &lt; or = to 2(12)&#xD;
&#xD;
          2. TIMI risk score of 3 with no known CAD, greater than 50% in one or more vessels&#xD;
&#xD;
          3. Normal cardiac biomarkers (3 sets over 12-88 hours)&#xD;
&#xD;
          4. No evidence of acute ischemia on electrocardiograms&#xD;
&#xD;
          5. Normal ejection fraction (&gt;40%) on echocardiography&#xD;
&#xD;
          6. Age 30-75&#xD;
&#xD;
          7. Ability to complete noninvasive stress test&#xD;
&#xD;
          8. Ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of another medical condition to explain chest pain or non-cardiac chest pain&#xD;
             (i.e. pneumonia, costochondritis)&#xD;
&#xD;
          2. Any patient who is initially classified as low risk but whom develops recurrent&#xD;
             symptoms of ischemia, hemodynamic instability, or arrhythmias attributable to ischemia&#xD;
&#xD;
          3. Evidence of ischemia on electrocardiogram&#xD;
&#xD;
          4. Abnormal cardiac biomarkers&#xD;
&#xD;
          5. History of medical noncompliance or social circumstances preventing compliance&#xD;
&#xD;
          6. Life span estimated at &lt;1 year&#xD;
&#xD;
          7. Pregnancy&#xD;
&#xD;
          8. Refusal to sign consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mazen S Abu-Fadel, MD, FACC, FSCAI</last_name>
    <role>Principal Investigator</role>
    <affiliation>OUHSC and VAMC OKC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Veteran's Affairs Medical Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>April 10, 2017</last_update_submitted>
  <last_update_submitted_qc>April 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oklahoma</investigator_affiliation>
    <investigator_full_name>Mazen Abu-Fadel, M.D.</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Low Risk ACS, Acute Coronary Syndrome, Stress Testing, Non-Stress Testing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT01703156
org study id: Low Risk ACS
secondary id: IRB#14542
nct id: NCT01703156
lead sponsor: 
collaborator: 
has dmc: Yes
A large number of patients are diagnosed with low risk ACS, and these individuals are at
      significant cardiovascular risk. Though guidelines recommend stress testing to manage low
      risk ACS patients, evidence supporting this recommendation is not based on trials examining
      this population. A well-designed, randomized trial is warranted to determine if stress
      testing is useful in managing low risk ACS. If medical therapy alone is equivalent as the
      investigators hypothesize, healthcare expenditures could be reduced and patients may not be
      exposed to the harms associated with more invasive cardiac testing such as coronary
      angiography.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Composite of all-cause mortality, hospitalization for UA/NSTEMI or STEMI, and urgent revascularization
time frame: one year
description: Primary endpoints include the composite of all-cause mortality, hospitalization for Unstable Angina/Non ST-Elevation Myocardial Infarction (UA/NSTEMI) or ST-Elevation Myocardial Infarction (STEMI), and urgent revascularization (coronary artery bypass grafting or percutaneous coronary intervention).
measure: Secondary endpoints will include mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects.
time frame: one year
description: Secondary endpoints will include: mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects.
arm group label: Non-Stress Group
arm group type: Experimental
description: Medical therapy will be implemented and will include the following: aspirin, clopidogrel, b-blockers, and statins. The dosages of aspirin, b-blocker and statin will be left to the discretion of the treating physician. Statins will be initiated irrespective of LDL unless contraindicated. Clopidogrel will be taken for at least one month and ideally up to one year. Sublingual nitroglycerin will be provided to all patients. Other anti-ischemic medications including long-acting nitrates, calcium channel blockers, and ranolazine may be provided at the treating physicians' discretion. If a patient has contraindications to any medications, they will not be administered. If a statin contraindication exists, other cholesterol-lowering medications may be administered. Appendix 4 shows the detailed management of low risk ACS patients randomized to the non-stress group.
arm group label: Stress Group
arm group type: Active Comparator
description: Medical therapy will be implemented and will include the following: aspirin, clopidogrel, b-blockers, and statins. Statins will be initiated irrespective of LDL unless contraindicated. Clopidogrel will be taken for at least one month and ideally up to one year. Sublingual nitroglycerin will be provided to all patients. Other anti-ischemic medications including long-acting nitrates, calcium channel blockers, and ranolazine may be provided at the treating physicians' discretion. If a statin contraindication exists, other cholesterol-lowering medications may be administered. All patients will undergo noninvasive stress testing. Results of individual stress tests will be reviewed by a cardiologist. Based on the myocardium deemed at risk and patient symptoms, further testing with angiography and revascularization using percutaneous techniques and/or coronary artery bypass grafting may be considered. Likewise, medical treatment may be adjusted.
intervention type: Procedure
intervention name: Stress Test
arm group label: Stress Group
intervention type: Procedure
intervention name: No Stress Test
arm group label: Non-Stress Group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mazen S Abu-Fadel, MD, FACC, FSCAI
role: Principal Investigator
affiliation: OUHSC and VAMC OKC
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Oklahoma
investigator full name: Mazen Abu-Fadel, M.D.
investigator title: Associate Professor of Medicine
mesh term: Acute Coronary Syndrome
mesh term: Syndrome