<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/NCT02201017</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-14-1194-IG-CTIL</org_study_id>
    <nct_id>NCT02201017</nct_id>
  </id_info>
  <brief_title>HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia</brief_title>
  <official_title>HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A total of 621 consecutive male and female subjects, without established CAD, referred to&#xD;
      exercise stress testing (EST) due to 1) chest pain syndromes or equivocal/equivalent angina&#xD;
      with intermediate pretest probability for CAD; 2) , or asymptomatic subjects with diabetes&#xD;
      mellitus who are referred EST for risk assessment prior to initiation of an exercise program.&#xD;
&#xD;
      To validate the diagnostic performance of the HeartTrends device for the detection and ruling&#xD;
      out of myocardial ischemia in a population of subjects who are currently referred for&#xD;
      cardiovascular evaluation using EST.&#xD;
&#xD;
      Prospective multicenter single-armed study, assessing the diagnostic accuracy of HRV analysis&#xD;
      by the HeartTrends device for the detection of myocardial ischemia, as determined by stress&#xD;
      echocardiography.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</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>Positive percent agreement</measure>
    <time_frame>1 year</time_frame>
    <description>Positive percent agreement of ≥70% (with a lower confidence interval of 60%) between a positive HRV HeartTrends test and a positive ESE</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>negative percent agreement</measure>
    <time_frame>1 year</time_frame>
    <description>HeartTrends device testing is associated with a negative percent agreement of ≥70% with negative results detected by ESE.&#xD;
≥10% difference between the positive percent agreement of HRV with ESE and the positive percent agreement of EST with ESE.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">621</enrollment>
  <condition>Heart Rate Variability Ischemia Detection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 621 consecutive male and female subjects, without established CAD, referred to&#xD;
        exercise stress testing (EST) due to 1) chest pain syndromes or equivocal/equivalent angina&#xD;
        with intermediate pretest probability for CAD; 2) , or asymptomatic subjects with diabetes&#xD;
        mellitus who are referred EST for risk assessment prior to initiation of an exercise&#xD;
        program.&#xD;
&#xD;
        Pretest probability of CAD will be based on the ACC 2002 guideline update on exercise&#xD;
        stress testing1.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 21&#xD;
&#xD;
          -  No known CAD&#xD;
&#xD;
          -  Referral for EST due to either one of the following two indications:&#xD;
&#xD;
               1. Chest pain syndrome or equivocal angina in subjects with intermediate pretest&#xD;
                  probability of CAD according to the 2002 updated guidelines for exercise stress&#xD;
                  examination.1 (See definition of intermediate pretest probability of CAD in&#xD;
                  Supplementary Appendix Table at the end of this document); or&#xD;
&#xD;
               2. Asymptomatic subjects with diabetes mellitus referred to EST for risk assessment&#xD;
                  prior to initiation of an exercise program.&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute Coronary Syndrome&#xD;
&#xD;
          2. Established CAD&#xD;
&#xD;
          3. Atrial fibrillation or flutter&#xD;
&#xD;
          4. Cardiac Pacemaker&#xD;
&#xD;
          5. Clinical diagnosis of heart failure&#xD;
&#xD;
          6. Severe COPD (FEV1&lt; 50% predicted value)&#xD;
&#xD;
          7. Active myocarditis, constrictive pericarditis, any cardiomyopathy, cardiac or systemic&#xD;
             amyloidosis&#xD;
&#xD;
          8. Known drug or alcohol dependence or any other factors which will interfere with the&#xD;
             study conduct or interpretation of the results or in the opinion of the investigator&#xD;
             are not suitable to participate;&#xD;
&#xD;
          9. Any illness that might reduce life expectancy to less than 1 year from screening&#xD;
&#xD;
         10. Left bundle branch block (LBBB), significant intra-ventricular conduction delay (IVCD)&#xD;
             or significant (&gt;1mm) ST deviations on baseline ECG&#xD;
&#xD;
         11. Inability to perform an exercise stress test (i.e. orthopedical or neurological&#xD;
             limitations)&#xD;
&#xD;
         12. Any significant valvular disease defined as:&#xD;
&#xD;
        Established valvular regurgitation or stenosis abnormality above moderate severity 13. BMI&#xD;
        &gt;35 kg/m2 14. Recent (&lt; 6 months) history of pulmonary embolism&#xD;
&#xD;
        -&#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>Ilan Goldenberg, MD</last_name>
    <role>Study Director</role>
    <affiliation>THE ISRAELI ASSOCIATION FOR CARDIOVASCULAR TRIALS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ilan Goldenberg, prof</last_name>
    <phone>03-5344703</phone>
    <email>Ilan.Goldenberg@sheba.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>MN 55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ilan Goldenberg, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sheba medical center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ilan Goldenberg, MD</last_name>
      <email>Ilan.Goldenberg@sheba.health.gov.il</email>
    </contact>
    <investigator>
      <last_name>refael Koperstein, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>July 23, 2014</last_update_submitted>
  <last_update_submitted_qc>July 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 2014</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>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Ischemia</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/NCT02201017
org study id: SHEBA-14-1194-IG-CTIL
nct id: NCT02201017
lead sponsor: 
has dmc: No
A total of 621 consecutive male and female subjects, without established CAD, referred to
      exercise stress testing (EST) due to 1) chest pain syndromes or equivocal/equivalent angina
      with intermediate pretest probability for CAD; 2) , or asymptomatic subjects with diabetes
      mellitus who are referred EST for risk assessment prior to initiation of an exercise program.

      To validate the diagnostic performance of the HeartTrends device for the detection and ruling
      out of myocardial ischemia in a population of subjects who are currently referred for
      cardiovascular evaluation using EST.

      Prospective multicenter single-armed study, assessing the diagnostic accuracy of HRV analysis
      by the HeartTrends device for the detection of myocardial ischemia, as determined by stress
      echocardiography.
observational model: Cohort
time perspective: Prospective
measure: Positive percent agreement
time frame: 1 year
description: Positive percent agreement of ≥70% (with a lower confidence interval of 60%) between a positive HRV HeartTrends test and a positive ESE
measure: negative percent agreement
time frame: 1 year
description: HeartTrends device testing is associated with a negative percent agreement of ≥70% with negative results detected by ESE.
≥10% difference between the positive percent agreement of HRV with ESE and the positive percent agreement of EST with ESE.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Ilan Goldenberg, MD
role: Study Director
affiliation: THE ISRAELI ASSOCIATION FOR CARDIOVASCULAR TRIALS
last name: Ilan Goldenberg, prof
phone: 03-5344703
email: Ilan.Goldenberg@sheba.health.gov.il
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
country: United States
responsible party type: Sponsor
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
mesh term: Ischemia