<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/NCT04467294</url>
  </required_header>
  <id_info>
    <org_study_id>2019-29</org_study_id>
    <secondary_id>2019-A01294-53</secondary_id>
    <nct_id>NCT04467294</nct_id>
  </id_info>
  <brief_title>Prospective Register on the Etiologies of Cardiogenic Shock and Their Prognosis at One Year.</brief_title>
  <acronym>cardiac shock</acronym>
  <official_title>Prospective Register on the Etiologies of Cardiogenic Shock and Their Prognosis at One Year.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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>
      Cardiogenic shock (CC) is one of the major challenges of current cardiology. Despite the&#xD;
      difficulty of establishing a strict and consensual definition, it is accepted that the CC&#xD;
      clinically corresponds to persistent hypotension (systolic blood pressure 90 mmHg for at&#xD;
      least 30 minutes or need for vasopressor support) associated with signs of visceral&#xD;
      hypoperfusion (confusion, mottling, oliguria, hyperlactatemia), and hemodynamic with a&#xD;
      lowered heart index ( 1.8 L/min/m2) despite appropriate or high filling pressures. This&#xD;
      definition of the European Society of Cardiology (ESC) masks however the great variability of&#xD;
      hemodynamic tables grouped under the term of CC and severity levels, also variable.However,&#xD;
      it was suggested that the etiology of CC influenced both its hemodynamic profile and&#xD;
      therefore its therapeutic management but also its prognosis in the medium and long term.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CC diagnosis remains difficult to carry on admission and is sometimes delayed. Therefore, we&#xD;
      would like to compare hemodynamic data from patients with CC status to those admitted for&#xD;
      acute heart failure (ICA) to determine if a hemodynamic variable at entry would facilitate&#xD;
      the diagnosis of CC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 4, 2020</start_date>
  <completion_date type="Anticipated">October 4, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 4, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>prevalence of Cardiac Shock</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>one month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">1650</enrollment>
  <condition>Cardiogenic Shock</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients in Cardiac Shock and patients admitted for acute heart failure (ICA)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients in Cardiac Shock :&#xD;
&#xD;
          -  90 mmHg hypotension or requiring inotropic or vasopressor support,&#xD;
&#xD;
          -  owered cardiac output ( 1.8 L/min/m2) to trans-thoracic cardiac ultrasound with high&#xD;
             or normal filling pressures&#xD;
&#xD;
          -  peripheral hypoperfusion. patients admitted for acute heart failure (ICA) (Acute&#xD;
             pulmonary edema chart or left congestive heart failure without CC sign and with&#xD;
             ultrasound FEVG at entry 40%.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing women&#xD;
&#xD;
          -  Age 18 years&#xD;
&#xD;
          -  Person of full age under guardianship&#xD;
&#xD;
          -  Staying in a health or social facility&#xD;
&#xD;
          -  Person not covered by a social security scheme&#xD;
&#xD;
          -  Person deprived of liberty&#xD;
&#xD;
          -  Shocks from other etiologies&#xD;
&#xD;
          -  Patient with initial cardiac arrest&#xD;
&#xD;
          -  Patient with cardiogenic shock due to right ventricular dysfunction&#xD;
&#xD;
          -  Patient with pulmonary embolism&#xD;
&#xD;
          -  Patient with tamponade&#xD;
&#xD;
          -  Refusal to participate&#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>Garrido-pradalie Emilie</last_name>
    <role>Study Director</role>
    <affiliation>ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>bonello laurent</last_name>
    <phone>0491968858</phone>
    <email>laurent.bonello@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <state>Paca</state>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>BONELLO LAURENT, PU PH</last_name>
      <phone>0491968858</phone>
      <email>laurent.bonello@ap-hm.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</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>Shock, Cardiogenic</mesh_term>
    <mesh_term>Shock</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/NCT04467294
org study id: 2019-29
secondary id: 2019-A01294-53
nct id: NCT04467294
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiogenic shock (CC) is one of the major challenges of current cardiology. Despite the
      difficulty of establishing a strict and consensual definition, it is accepted that the CC
      clinically corresponds to persistent hypotension (systolic blood pressure 90 mmHg for at
      least 30 minutes or need for vasopressor support) associated with signs of visceral
      hypoperfusion (confusion, mottling, oliguria, hyperlactatemia), and hemodynamic with a
      lowered heart index ( 1.8 L/min/m2) despite appropriate or high filling pressures. This
      definition of the European Society of Cardiology (ESC) masks however the great variability of
      hemodynamic tables grouped under the term of CC and severity levels, also variable.However,
      it was suggested that the etiology of CC influenced both its hemodynamic profile and
      therefore its therapeutic management but also its prognosis in the medium and long term.
CC diagnosis remains difficult to carry on admission and is sometimes delayed. Therefore, we
      would like to compare hemodynamic data from patients with CC status to those admitted for
      acute heart failure (ICA) to determine if a hemodynamic variable at entry would facilitate
      the diagnosis of CC.
observational model: Cohort
time perspective: Prospective
measure: prevalence of Cardiac Shock
time frame: 12 months
measure: mortality
time frame: one month
measure: mortality
time frame: one year
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Garrido-pradalie Emilie
role: Study Director
affiliation: ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
last name: bonello laurent
phone: 0491968858
email: laurent.bonello@ap-hm.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Shock, Cardiogenic
mesh term: Shock
sharing ipd: No