<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/NCT03001206</url>
  </required_header>
  <id_info>
    <org_study_id>CL-MCG-02</org_study_id>
    <nct_id>NCT03001206</nct_id>
  </id_info>
  <brief_title>The Use of the Master Caution System (MCS) for Continuous Monitoring and Detection of Dysrhythmias and Ischemic Events</brief_title>
  <official_title>The Use of Master Caution System for Continuous Monitoring and Detection of Dysrhythmia and Ischemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HealthWatch Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HealthWatch Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effectiveness and usability of the Master&#xD;
      Caution System for 12 leads continuous monitoring of ECG signal in the ICCU.&#xD;
&#xD;
      The purpose of the study is to evaluate the effectiveness and usability of using Master&#xD;
      Caution 12 leads Garment for stress test.&#xD;
&#xD;
      The purpose of the study is to reassess the adequate size of the Master Caution Garment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measuring 12 leads ECG information of patients at the ICCU in continuous monitoring using Master Caution System (MCS) will give more cardiac information comparing to regular hospital 2-3 leads telemetry.</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Measuring 12 leads ECG information of patients at the stress test using Master Caution System (MCS) comparing to the standard of care stress test ECG device and Electrodes.</measure>
    <time_frame>1-2 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Master Caution System (MCS) cardiac telemetry system will measure and provide sufficient ECG information for adequate detection and interpretation of ST-T wave changes and dysrhythmic events.</measure>
    <time_frame>during the use of the system</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">84</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>ICCU patients</arm_group_label>
    <description>The use of the Master Caution System (MCS) for continuous monitoring and detection of dysrhythmias and ischemic events :&#xD;
For patient diagnosed with acute coronary syndrome (ACS) in the intensive cardiac care unit (ICCU) before and after planed catheterization procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stress test subjects</arm_group_label>
    <description>The use of the Master Caution System (MCS) for continuous monitoring and detection of dysrhythmias and ischemic events :&#xD;
For patients referred to stress imaging with suspected ischemia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Master Caution System</intervention_name>
    <description>The purpose of this study is to evaluate the effectiveness and usability of the Master Caution System for 12 leads continuous monitoring of ECG signal in the ICCU.&#xD;
The purpose of the study is to evaluate the effectiveness and usability of using Master Caution 12 leads Garment for stress test.&#xD;
The purpose of the study is to reassess the adequate size of the Master Caution Garment (MCG).</description>
    <arm_group_label>ICCU patients</arm_group_label>
    <arm_group_label>Stress test subjects</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible subjects admitted and diagnosed as acute coronary syndrome, before or after&#xD;
        catheterization, who need to be monitored for evaluation of treatment efficacy.&#xD;
&#xD;
        Eligible subjects referred to stress imaging test, with current or previously depicted STT&#xD;
        changes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt;18 years.&#xD;
&#xD;
          -  Diagnosed or have evidence of ACS, or referred for stress imaging due to suspected&#xD;
             ischemia with STT changes.&#xD;
&#xD;
          -  Needs continuous/routine ECG monitoring.&#xD;
&#xD;
          -  Ability to give informed consent.&#xD;
&#xD;
          -  Cooperative person&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known allergy to silver.&#xD;
&#xD;
          -  Patients with dermal disease or recent trauma to the chest wall.&#xD;
&#xD;
          -  Pregnant or lactating woman.&#xD;
&#xD;
          -  Patients with chest deformity precluding placement of the garment.&#xD;
&#xD;
          -  Patients suffering from tremor.&#xD;
&#xD;
          -  Patients participating in another ongoing trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Morris Mosseri, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meir Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar Saba</city>
        <zip>4442500</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>August 7, 2018</last_update_submitted>
  <last_update_submitted_qc>August 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2018</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>Acute Coronary Syndrome</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/NCT03001206
org study id: CL-MCG-02
nct id: NCT03001206
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the effectiveness and usability of the Master
      Caution System for 12 leads continuous monitoring of ECG signal in the ICCU.

      The purpose of the study is to evaluate the effectiveness and usability of using Master
      Caution 12 leads Garment for stress test.

      The purpose of the study is to reassess the adequate size of the Master Caution Garment.
observational model: Cohort
time perspective: Retrospective
measure: Measuring 12 leads ECG information of patients at the ICCU in continuous monitoring using Master Caution System (MCS) will give more cardiac information comparing to regular hospital 2-3 leads telemetry.
time frame: 48 hours
measure: Measuring 12 leads ECG information of patients at the stress test using Master Caution System (MCS) comparing to the standard of care stress test ECG device and Electrodes.
time frame: 1-2 hours
measure: Master Caution System (MCS) cardiac telemetry system will measure and provide sufficient ECG information for adequate detection and interpretation of ST-T wave changes and dysrhythmic events.
time frame: during the use of the system
arm group label: ICCU patients
description: The use of the Master Caution System (MCS) for continuous monitoring and detection of dysrhythmias and ischemic events :
For patient diagnosed with acute coronary syndrome (ACS) in the intensive cardiac care unit (ICCU) before and after planed catheterization procedure.
arm group label: Stress test subjects
description: The use of the Master Caution System (MCS) for continuous monitoring and detection of dysrhythmias and ischemic events :
For patients referred to stress imaging with suspected ischemia.
intervention type: Device
intervention name: Master Caution System
description: The purpose of this study is to evaluate the effectiveness and usability of the Master Caution System for 12 leads continuous monitoring of ECG signal in the ICCU.
The purpose of the study is to evaluate the effectiveness and usability of using Master Caution 12 leads Garment for stress test.
The purpose of the study is to reassess the adequate size of the Master Caution Garment (MCG).
arm group label: ICCU patients
arm group label: Stress test subjects
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Morris Mosseri, Prof.
role: Principal Investigator
affiliation: Meir Medical Center
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
sharing ipd: No