<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/NCT02993263</url>
  </required_header>
  <id_info>
    <org_study_id>15-1556</org_study_id>
    <nct_id>NCT02993263</nct_id>
  </id_info>
  <brief_title>Postoperative Acute Myocardial Ischemic Injury</brief_title>
  <official_title>Detection and Prediction of Postoperative Acute Myocardial Ischemic Injury/Infarction by the VectraplexECG System With CEB®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose to estimate the sensitivity and specificity of the VectraplexECG&#xD;
      System for detecting acute myocardial ischemic injury, including acute myocardial infarctions&#xD;
      after major non-cardiac surgery.&#xD;
&#xD;
      A 10 second CEB dynamic sequence recording will be obtained immediately after surgery in the&#xD;
      post-anesthesia care unit.&#xD;
&#xD;
      On the first, second and third post operative morning a 10 second CEB dynamic sequence will&#xD;
      be recorded. Blood will be sampled for troponin as well.&#xD;
&#xD;
      On the first, second and third post operative afternoons a 10 second CEB dynamic sequence&#xD;
      will be recorded.&#xD;
&#xD;
      The morning 10 second CEB dynamic sequence and blood draw for troponin will continue as long&#xD;
      as the patient remains hospitalized. The afternoon 10 second CEB dynamic sequence will&#xD;
      continue as long as the patient remains hospitalized.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was withdrawn as there was an ECG equipment and software malfunction. There is no&#xD;
    results for this study because of the equipment malfunction.&#xD;
  </why_stopped>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 14, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy</measure>
    <time_frame>1 minute to complete the test</time_frame>
    <description>Accuracy of VectraplexECG System with CEB</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">323</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Noncardiac surgery</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>VectraplexECG System with CEB® will be recorded after surgery and on day 1, 2 and 3 post operatively</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VectraplexECG System with CEB®</intervention_name>
    <description>The device will be used after noncardiac surgery</description>
    <arm_group_label>Noncardiac surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent.&#xD;
&#xD;
          2. ≥ 45 years old.&#xD;
&#xD;
          3. Anticipated hospitalization of at least two nights.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inadequate ECGs, based on an initial 10-second trace, as defined by:&#xD;
&#xD;
               -  wandering baseline&#xD;
&#xD;
               -  excessive noise&#xD;
&#xD;
               -  ventricular ectopy&#xD;
&#xD;
               -  pacer spikes or&#xD;
&#xD;
               -  lead placement error&#xD;
&#xD;
          2. Atrial fibrillation.&#xD;
&#xD;
          3. Average heart rate exceeding 90 beats/minute.&#xD;
&#xD;
          4. Evidence of previous myocardial infarction:&#xD;
&#xD;
               -  Pathologic Q waves (≥0.04 sec) and/or&#xD;
&#xD;
               -  Pathologic findings of a healed or healing MI and/or&#xD;
&#xD;
               -  Evidence from an imaging study of a region of loss of viable myocardium&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Sessler, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <results_first_submitted>September 20, 2021</results_first_submitted>
  <results_first_submitted_qc>December 14, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 11, 2022</results_first_posted>
  <last_update_submitted>December 14, 2021</last_update_submitted>
  <last_update_submitted_qc>December 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</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 Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT02993263/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment process started by screening patients who are scheduled for non cardiac surgery. These patients are approached during their anesthesia clearance visit.</recruitment_details>
      <pre_assignment_details>Open label study</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Noncardiac Surgery</title>
          <description>VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="323"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="323"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Equipment Software failed and results were lost.</title>
              <participants_list>
                <participants group_id="P1" count="323"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Noncardiac Surgery</title>
          <description>VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="323"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="323"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.9" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="323"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="164"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Accuracy</title>
        <description>Accuracy of VectraplexECG System with CEB</description>
        <time_frame>1 minute to complete the test</time_frame>
        <population>Data were not collected, because of the malfunction of the equipment software failed.</population>
        <group_list>
          <group group_id="O1">
            <title>Noncardiac Surgery</title>
            <description>VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively</description>
          </group>
        </group_list>
        <measure>
          <title>Accuracy</title>
          <description>Accuracy of VectraplexECG System with CEB</description>
          <population>Data were not collected, because of the malfunction of the equipment software failed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days</time_frame>
      <desc>All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Noncardiac Surgery</title>
          <description>VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Daniel Sessler, MD</name_or_title>
      <organization>Cleveland Clinic</organization>
      <phone>216-444-9400</phone>
      <email>sesslers@ccf.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02993263
org study id: 15-1556
nct id: NCT02993263
lead sponsor: 
has dmc: No
The investigators propose to estimate the sensitivity and specificity of the VectraplexECG
      System for detecting acute myocardial ischemic injury, including acute myocardial infarctions
      after major non-cardiac surgery.

      A 10 second CEB dynamic sequence recording will be obtained immediately after surgery in the
      post-anesthesia care unit.

      On the first, second and third post operative morning a 10 second CEB dynamic sequence will
      be recorded. Blood will be sampled for troponin as well.

      On the first, second and third post operative afternoons a 10 second CEB dynamic sequence
      will be recorded.

      The morning 10 second CEB dynamic sequence and blood draw for troponin will continue as long
      as the patient remains hospitalized. The afternoon 10 second CEB dynamic sequence will
      continue as long as the patient remains hospitalized.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Accuracy
time frame: 1 minute to complete the test
description: Accuracy of VectraplexECG System with CEB
arm group label: Noncardiac surgery
arm group type: Other
description: VectraplexECG System with CEB® will be recorded after surgery and on day 1, 2 and 3 post operatively
intervention type: Device
intervention name: VectraplexECG System with CEB®
description: The device will be used after noncardiac surgery
arm group label: Noncardiac surgery
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Sessler, M.D.
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 