<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/NCT02983396</url>
  </required_header>
  <id_info>
    <org_study_id>UniversityGhent</org_study_id>
    <nct_id>NCT02983396</nct_id>
  </id_info>
  <brief_title>The Accuracy of the Mini RELF Device for the Diagnosis of an Acute Coronary Artery Occlusion.</brief_title>
  <acronym>RELF IIa</acronym>
  <official_title>The Accuracy of the Mini RELF Device Relative to the 12 Lead ECG for the Diagnosis of an Acute Coronary Artery Occlusion in Patients With Coronary Artery Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Ghent</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patient delay in seeking medical attendance for symptoms of acute ST elevation myocardial&#xD;
      infarction (STEMI) is the major obstacle to reduce the current mortality from acute coronary&#xD;
      syndromes. The Mini RELF device is a hand held self applicable device intended to detect on&#xD;
      an individual basis an elevation of the ST segment that is indicative for an acute coronary&#xD;
      occlusion. The investigators aim to evaluate the accuracy of Mini RELF device when it is&#xD;
      self-applied on a daily basis by patients with coronary artery disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The increasing availability of small hand held medical devices is a novel opportunity to&#xD;
      develop a tool that guides patients through the decision-taking processes of seeking medical&#xD;
      attendance during symptoms suggestive of acute myocardial infarction. The cornerstone of&#xD;
      early diagnosis, risk stratification and treatment is the presence of ST segment elevation&#xD;
      during symptoms suggestive of STEMI. Therefore, a hand held medical device that can detect ST&#xD;
      segment elevation with high sensitivity and specificity could be a breakthrough in the&#xD;
      further reduction of fatality from acute myocardial infarction. A number of conditions of the&#xD;
      tool must be fulfilled to allow save use with a low threshold in the general population. Most&#xD;
      important is the accuracy to detect any new ST segment elevation related to an acute artery&#xD;
      occlusion. For more than 30 years the 12-lead ECG is the gold standard for detection of ST&#xD;
      elevation. However, acute coronary occlusions of a posterior or lateral segment are not&#xD;
      always detected by the gold standard. Moreover, in the very early phase of acute coronary&#xD;
      occlusion, the accuracy 12 lead ECG is inadequate.&#xD;
&#xD;
      In a previous study &quot;Diagnostic accuracy of a novel method for detection of acute transmural&#xD;
      myocardial ischemia based upon a self-applicable 3-lead configuration&quot; the investigators&#xD;
      developed and validated a sensitive and specific 3-lead ECG method (RELF method). The method&#xD;
      includes a new lead configuration and a new algorithm to analyze the ECG recordings based on&#xD;
      an intra-individual comparisons of ST levels. In summary, a 3-lead recording from a healthy&#xD;
      subject or from a patient with an acute coronary occlusion is compared automatically to one&#xD;
      or more previous reference recordings from the same individual. The individualized ST shift&#xD;
      is used as a decision variable to detect or reject an acute coronary artery occlusion. The&#xD;
      RELF method was more accurate then the simultaneously applied 12-lead ECG which had a lower&#xD;
      sensitivity and specificity. In that study all recordings were performed by a sophisticated&#xD;
      ECG recording system. The RELF method is designed to be applicable also by small hand held&#xD;
      ECG devices such as the self-applicable Mini RELF device.&#xD;
&#xD;
      In the current study the investigators aim to evaluate the accuracy of Mini RELF device&#xD;
      relative to the 12 lead ECG when the device is self-applied on a daily basis by patients with&#xD;
      coronary artery disease. In a parallel study (RELF IIb) the investigators aim to evaluate the&#xD;
      specificity of the RELF method when it is self-applied by healthy subjects who are&#xD;
      representative for future users of the device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 18, 2016</start_date>
  <completion_date type="Actual">April 19, 2018</completion_date>
  <primary_completion_date type="Actual">April 19, 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>The accuracy (Area under the sensitivity-aspecificity curve) of Modus RELF-2 (The orthonormalized ST shift vector magnitude)</measure>
    <time_frame>One week after coronary angioplasty</time_frame>
    <description>The sensitivity and specificity of the orthonormalized ST shift vector magnitude during occlusion compared to the sensitivity and specificity of the 12 lead ECG.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The accuracy (Area under the sensitivity-aspecificity curve) of Modus RELF-3</measure>
    <time_frame>One week after coronary angioplasty</time_frame>
    <description>The sensitivity and specificity of the intraindividual orthonormalized ST shift vector magnitude</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The accuracy (Area under the sensitivity-aspecificity curve) of Modus RELF-1 (The gender specific orthonormalized ST vector magnitude) and of Modus RELF-3 (The intra-individual orthonormalized ST shift vector magnitude).</measure>
    <time_frame>One week after coronary angioplasty</time_frame>
    <description>The sensitivity and specificity of the gender specific orthonormalized ST vector magnitude and the intra-individual orthonormalized ST shift vector magnitude during occlusion compared to the sensitivity and specificity of the 12 lead ECG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with symptoms of contact dermatitis in the thoracic device-skin contact area.</measure>
    <time_frame>One week after coronary angioplasty</time_frame>
    <description>Contact dermatitis is defined by the clinical presence of redness or itching or blistering delineated in the thoracic device-skin contact area during at least one of the three clinical visits in the study participation period.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Chest Pain</condition>
  <condition>ST Elevation Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>no transmural ischemia (NTI) and transmural ischemia (TI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Case cross-over from &quot;no transmural ischemia (NTI)&quot; to &quot;transmural ischemia at 60 s coronary occlusion during elective coronary angioplasty (TI)&quot;&#xD;
Comparison of diagnostic accuracy of standard 12-lead ECG versus Mini RELF device for detection of transmural ischemia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Diagnostic accuracy of Mini Relf Device</intervention_name>
    <description>Evaluation of the Mini Relf Device when it is applied on daily basis at home and during coronary angioplasty at 60 second acute coronary occlusion angioplasty</description>
    <arm_group_label>no transmural ischemia (NTI) and transmural ischemia (TI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have an appointment for an elective coronary angioplasty.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with coronary artery bypass grafts.&#xD;
&#xD;
          -  Patients with implanted pacemaker or ICD.&#xD;
&#xD;
          -  Patients who remain hospitalized until the planned angioplasty.&#xD;
&#xD;
          -  Patient who are unfamiliar with use of smart phone. The test question &quot;did you use by&#xD;
             yourself a smart phone to make a telephone call in the last 4 weeks&quot; should be&#xD;
             answered by yes.&#xD;
&#xD;
          -  Patients who cannot tolerate repetitive applications of standard skin electrodes on&#xD;
             the chest.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Gheeraert, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>University Ghent, Belgium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Algemeen Ziekenhuis Sint-Jan Brugge</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Ghent</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint Nikolaas</name>
      <address>
        <city>Sint-Niklaas</city>
        <zip>9100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>October 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 2, 2021</last_update_submitted>
  <last_update_submitted_qc>December 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RELF method</keyword>
  <keyword>Medical device</keyword>
  <keyword>Admission delay</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Coronary Occlusion</mesh_term>
    <mesh_term>Infarction</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/NCT02983396
org study id: UniversityGhent
nct id: NCT02983396
lead sponsor: 
has dmc: Yes
Patient delay in seeking medical attendance for symptoms of acute ST elevation myocardial
      infarction (STEMI) is the major obstacle to reduce the current mortality from acute coronary
      syndromes. The Mini RELF device is a hand held self applicable device intended to detect on
      an individual basis an elevation of the ST segment that is indicative for an acute coronary
      occlusion. The investigators aim to evaluate the accuracy of Mini RELF device when it is
      self-applied on a daily basis by patients with coronary artery disease.
The increasing availability of small hand held medical devices is a novel opportunity to
      develop a tool that guides patients through the decision-taking processes of seeking medical
      attendance during symptoms suggestive of acute myocardial infarction. The cornerstone of
      early diagnosis, risk stratification and treatment is the presence of ST segment elevation
      during symptoms suggestive of STEMI. Therefore, a hand held medical device that can detect ST
      segment elevation with high sensitivity and specificity could be a breakthrough in the
      further reduction of fatality from acute myocardial infarction. A number of conditions of the
      tool must be fulfilled to allow save use with a low threshold in the general population. Most
      important is the accuracy to detect any new ST segment elevation related to an acute artery
      occlusion. For more than 30 years the 12-lead ECG is the gold standard for detection of ST
      elevation. However, acute coronary occlusions of a posterior or lateral segment are not
      always detected by the gold standard. Moreover, in the very early phase of acute coronary
      occlusion, the accuracy 12 lead ECG is inadequate.

      In a previous study "Diagnostic accuracy of a novel method for detection of acute transmural
      myocardial ischemia based upon a self-applicable 3-lead configuration" the investigators
      developed and validated a sensitive and specific 3-lead ECG method (RELF method). The method
      includes a new lead configuration and a new algorithm to analyze the ECG recordings based on
      an intra-individual comparisons of ST levels. In summary, a 3-lead recording from a healthy
      subject or from a patient with an acute coronary occlusion is compared automatically to one
      or more previous reference recordings from the same individual. The individualized ST shift
      is used as a decision variable to detect or reject an acute coronary artery occlusion. The
      RELF method was more accurate then the simultaneously applied 12-lead ECG which had a lower
      sensitivity and specificity. In that study all recordings were performed by a sophisticated
      ECG recording system. The RELF method is designed to be applicable also by small hand held
      ECG devices such as the self-applicable Mini RELF device.

      In the current study the investigators aim to evaluate the accuracy of Mini RELF device
      relative to the 12 lead ECG when the device is self-applied on a daily basis by patients with
      coronary artery disease. In a parallel study (RELF IIb) the investigators aim to evaluate the
      specificity of the RELF method when it is self-applied by healthy subjects who are
      representative for future users of the device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The accuracy (Area under the sensitivity-aspecificity curve) of Modus RELF-2 (The orthonormalized ST shift vector magnitude)
time frame: One week after coronary angioplasty
description: The sensitivity and specificity of the orthonormalized ST shift vector magnitude during occlusion compared to the sensitivity and specificity of the 12 lead ECG.
measure: The accuracy (Area under the sensitivity-aspecificity curve) of Modus RELF-3
time frame: One week after coronary angioplasty
description: The sensitivity and specificity of the intraindividual orthonormalized ST shift vector magnitude
measure: The accuracy (Area under the sensitivity-aspecificity curve) of Modus RELF-1 (The gender specific orthonormalized ST vector magnitude) and of Modus RELF-3 (The intra-individual orthonormalized ST shift vector magnitude).
time frame: One week after coronary angioplasty
description: The sensitivity and specificity of the gender specific orthonormalized ST vector magnitude and the intra-individual orthonormalized ST shift vector magnitude during occlusion compared to the sensitivity and specificity of the 12 lead ECG.
measure: Number of participants with symptoms of contact dermatitis in the thoracic device-skin contact area.
time frame: One week after coronary angioplasty
description: Contact dermatitis is defined by the clinical presence of redness or itching or blistering delineated in the thoracic device-skin contact area during at least one of the three clinical visits in the study participation period.
arm group label: no transmural ischemia (NTI) and transmural ischemia (TI)
arm group type: Experimental
description: Case cross-over from "no transmural ischemia (NTI)" to "transmural ischemia at 60 s coronary occlusion during elective coronary angioplasty (TI)"
Comparison of diagnostic accuracy of standard 12-lead ECG versus Mini RELF device for detection of transmural ischemia.
intervention type: Device
intervention name: Diagnostic accuracy of Mini Relf Device
description: Evaluation of the Mini Relf Device when it is applied on daily basis at home and during coronary angioplasty at 60 second acute coronary occlusion angioplasty
arm group label: no transmural ischemia (NTI) and transmural ischemia (TI)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Peter Gheeraert, Professor
role: Study Chair
affiliation: University Ghent, Belgium
facility: 
facility: 
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Coronary Occlusion
mesh term: Infarction
mesh term: Chest Pain
sharing ipd: No