<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/NCT03011073</url>
  </required_header>
  <id_info>
    <org_study_id>EPIC</org_study_id>
    <nct_id>NCT03011073</nct_id>
  </id_info>
  <brief_title>Evaluation of New Items in Cardiac Echography</brief_title>
  <acronym>EPIC</acronym>
  <official_title>Evaluation of New Items in Cardiac Echography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Paris Saint Joseph hospital has just acquired a new echocardiography EPIC . This new system&#xD;
      has image processing and left ventricular function quantification software which are&#xD;
      different from the precedent model Philips IE33.Left ventricular function quantification and&#xD;
      myocardial distortion are the main medical examination influencing doctor's decisions.&#xD;
&#xD;
      EPIC can evaluate and quantify the cardiac ejection fraction via new software. Myocardial&#xD;
      distortion quantification software also has been modified with new cut off and different&#xD;
      calculation method.&#xD;
&#xD;
      The aim of this study is to compare the quality of images and the quantification of cardiac&#xD;
      ejection fraction with these new software in order to choose the more reliable and&#xD;
      reproducible for patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    investigator decision&#xD;
  </why_stopped>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">October 6, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac left ejection fraction</measure>
    <time_frame>Day 1</time_frame>
    <description>Evaluation of left ejection fraction by 3D</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Echographic images evaluation</measure>
    <time_frame>day 1</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Cardiac Echography</condition>
  <condition>Cardiac Ultrasound</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patient who have prescription to do an cardiac ultrasound&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient accepting to stay 15 min more&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient not accepting this procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <removed_countries>
    <country>France</country>
  </removed_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>November 7, 2017</last_update_submitted>
  <last_update_submitted_qc>November 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03011073
org study id: EPIC
nct id: NCT03011073
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Paris Saint Joseph hospital has just acquired a new echocardiography EPIC . This new system
      has image processing and left ventricular function quantification software which are
      different from the precedent model Philips IE33.Left ventricular function quantification and
      myocardial distortion are the main medical examination influencing doctor's decisions.

      EPIC can evaluate and quantify the cardiac ejection fraction via new software. Myocardial
      distortion quantification software also has been modified with new cut off and different
      calculation method.

      The aim of this study is to compare the quality of images and the quantification of cardiac
      ejection fraction with these new software in order to choose the more reliable and
      reproducible for patient.
observational model: Case-Only
time perspective: Prospective
measure: Cardiac left ejection fraction
time frame: Day 1
description: Evaluation of left ejection fraction by 3D
measure: Echographic images evaluation
time frame: day 1
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
country: France
responsible party type: Sponsor
sharing ipd: No