<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/NCT03012308</url>
  </required_header>
  <id_info>
    <org_study_id>6655 - ECHOPOG</org_study_id>
    <nct_id>NCT03012308</nct_id>
  </id_info>
  <brief_title>Trans-thoracic Ultrasound VS Invasive Pressure of the Left Atrium</brief_title>
  <acronym>ECHOPOG</acronym>
  <official_title>Evaluation of Left Ventricular Filling Pressures in Post-operative Cardiac Surgery: Trans-thoracic Ultrasound VS Invasive Pressure of the Left Atrium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</source>
  <oversight_info>
    <has_dmc>No</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>
      As part of cardiac and hemodynamic evaluation of patients, echocardiographic measurements&#xD;
      allow indirect evaluation of left ventricular filling pressures (LVFP). These ultrasound&#xD;
      parameters, including mitral valve doppler and mitral ring doppler (in particular the E / E&#xD;
      'ratio), are well validated in medical cardiology and in some resuscitation patients. The&#xD;
      measurement of filling pressures is an important daily element in the medical management of&#xD;
      patients in intensive care, in particular on the hemodynamic and respiratory levels. No&#xD;
      studies have evaluated the relevance of these markers in a postoperative context of cardiac&#xD;
      surgery. Indeed, the surgery alters the cardiac function, which could modify the values of&#xD;
      the echocardiographic parameters and their predictability. Left atrium pressure (LAP)&#xD;
      directly reflects LVFP and is measured in cardiac surgical resuscitation by a surgically&#xD;
      placed catheter as part of routine institutional care and will serve as gold-standard. To&#xD;
      study the clinical significance of these LAP and LVFP values estimated by cardiac ultrasound,&#xD;
      we will study their correlation with clinical and ultrasound signs of acute lung edema (ALE).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 20, 2016</start_date>
  <completion_date type="Anticipated">December 20, 2017</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2017</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>Compare the mean values of LAP between the group &quot;high filling pressures&quot; and the group &quot;non-high filling pressures&quot;</measure>
    <time_frame>6 postoperative hours of cardiac surgery of patients hospitalized in surgical resuscitation</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Myocardial Dysfunction</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient hospitalized in surgical resuscitation for cardiac surgery with heart-lung bypass&#xD;
        machine, aged over 18 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient hospitalized in surgical resuscitation for cardiac surgery with heart-lung&#xD;
             bypass machine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No consent&#xD;
&#xD;
          -  Mitral valve surgery&#xD;
&#xD;
          -  severe MI / severe mitral narrowing.&#xD;
&#xD;
          -  Absence of POG catheter&#xD;
&#xD;
          -  Urgent surgery&#xD;
&#xD;
          -  Heart transplant / mechanical assistance&#xD;
&#xD;
          -  Classics: minors, pregnant women, guardianship / curatorship / safeguarding,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gharib AJOB, MD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Strasbourg, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul-Michel MERTES, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Strasbourg, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gharib AJOB, MD</last_name>
    <phone>33 3 69 54 97 58</phone>
    <email>gharib.ajob@chru-strasbourg.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Paul-Michel MERTES, MD, PhD</last_name>
    <phone>33 3 69 55 15 78</phone>
    <email>paul-michel.mertes@chru-strasbourg.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service Réanimation chirurgicale cardio-vasculaire - NHC</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gharib AJOB, MD</last_name>
      <phone>33 3 69 54 97 58</phone>
      <email>gharib.ajob@chrustrasbourg.fr</email>
    </contact>
    <contact_backup>
      <last_name>Paul-Michel MERTES, MD, PhD</last_name>
      <phone>33 3 69 55 15 78</phone>
      <email>paul-michel.mertes@chru-strasbourg.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Thibaut WIPF, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>May 11, 2017</last_update_submitted>
  <last_update_submitted_qc>May 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myocardial Dysfunction</keyword>
  <keyword>left ventricular</keyword>
  <keyword>mitral valve doppler</keyword>
  <keyword>mitral ring doppler</keyword>
  <keyword>ultrasound signs</keyword>
  <keyword>lung edema</keyword>
  <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/NCT03012308
org study id: 6655 - ECHOPOG
nct id: NCT03012308
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
As part of cardiac and hemodynamic evaluation of patients, echocardiographic measurements
      allow indirect evaluation of left ventricular filling pressures (LVFP). These ultrasound
      parameters, including mitral valve doppler and mitral ring doppler (in particular the E / E
      'ratio), are well validated in medical cardiology and in some resuscitation patients. The
      measurement of filling pressures is an important daily element in the medical management of
      patients in intensive care, in particular on the hemodynamic and respiratory levels. No
      studies have evaluated the relevance of these markers in a postoperative context of cardiac
      surgery. Indeed, the surgery alters the cardiac function, which could modify the values of
      the echocardiographic parameters and their predictability. Left atrium pressure (LAP)
      directly reflects LVFP and is measured in cardiac surgical resuscitation by a surgically
      placed catheter as part of routine institutional care and will serve as gold-standard. To
      study the clinical significance of these LAP and LVFP values estimated by cardiac ultrasound,
      we will study their correlation with clinical and ultrasound signs of acute lung edema (ALE).
observational model: Cohort
time perspective: Retrospective
measure: Compare the mean values of LAP between the group "high filling pressures" and the group "non-high filling pressures"
time frame: 6 postoperative hours of cardiac surgery of patients hospitalized in surgical resuscitation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gharib AJOB, MD
role: Study Director
affiliation: University Hospital, Strasbourg, France
last name: Paul-Michel MERTES, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Strasbourg, France
last name: Gharib AJOB, MD
phone: 33 3 69 54 97 58
email: gharib.ajob@chru-strasbourg.fr
last name: Paul-Michel MERTES, MD, PhD
phone: 33 3 69 55 15 78
email: paul-michel.mertes@chru-strasbourg.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: France
responsible party type: Sponsor
sharing ipd: No