<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/NCT03252613</url>
  </required_header>
  <id_info>
    <org_study_id>1050374</org_study_id>
    <nct_id>NCT03252613</nct_id>
  </id_info>
  <brief_title>Translational Approaches to Septic Cardiomyopathy</brief_title>
  <acronym>TASC01</acronym>
  <official_title>Translational Approaches to Septic Cardiomyopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samuel Brown</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Euan Ashley</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Intermountain Health Care, Inc.</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>
      This translational study will assess the association between septic cardiomyopathy (measured&#xD;
      via left ventricular global longitudinal strain) and (a) inflammatory cytokine profiles, and&#xD;
      (b) the behavior of cardiomyocytes derived from inducible pluripotent stem cells.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 19, 2017</start_date>
  <completion_date type="Anticipated">October 27, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 27, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of cytokine profile with left ventricular global longitudinal strain</measure>
    <time_frame>Day 1</time_frame>
    <description>This outcome assesses the correlation between inflammatory cytokines (summarized via PCA) and septic cardiomyopathy, as assessed by left ventricular global longitudinal strain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adrenergic susceptibility of pluripotent stem cell-derived cardiomyocytes</measure>
    <time_frame>Day 1</time_frame>
    <description>This is a laboratory-based outcome, using pluripotent stem cell-derived cardiomyocytes, with exposure to adrenergic agonists and antagonists in vitro</description>
  </secondary_outcome>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Cardiomyopathies</condition>
  <condition>Sepsis</condition>
  <condition>Septic Shock</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The population of study subjects must be 18 years of age, admitted to an ICU and have&#xD;
        sepsis or septic shock as defined in the above inclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        INCLUSION CRITERIA&#xD;
&#xD;
        At least 18 years of age Admitted to the ICU&#xD;
&#xD;
        SEPSIS PATIENTS:&#xD;
&#xD;
        Sepsis patients must have:&#xD;
&#xD;
          1. Suspected or confirmed infection AND&#xD;
&#xD;
          2. Organ dysfunction as defined by a SOFA &gt;= 2 above baseline (if no baseline data&#xD;
             available, SOFA assumed to be 0)&#xD;
&#xD;
        OR&#xD;
&#xD;
        SEPTIC SHOCK PATIENTS:&#xD;
&#xD;
        AFTER INFUSION OF 20ML/KG CRYSTALLOID OR EQUIVALENT, septic shock patients must have:&#xD;
&#xD;
          1. Suspected or confirmed infection AND&#xD;
&#xD;
          2. Lactate &gt; 2 mmol/L AND&#xD;
&#xD;
          3. Receiving vasopressors&#xD;
&#xD;
        EXCLUSION CRITERIA Known pregnancy Primary diagnosis of acute coronary syndrome Known&#xD;
        preexisting heart disease Known severe valvular disease (regurgitation or stenosis)&#xD;
&#xD;
        Major cardiac dysrhythmia such as:&#xD;
&#xD;
          -  Ventricular tachycardia (V-tach)&#xD;
&#xD;
          -  Ventricular Fibrillation (V-fib)&#xD;
&#xD;
          -  Third degree heart block (complete hear block or complete AV block)&#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>Samuel Brown, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Intermountain Health Care, Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Euan Ashley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermoutain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Intermountain Health Care, Inc.</investigator_affiliation>
    <investigator_full_name>Samuel Brown</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>septic cardiomyopathy</keyword>
  <keyword>cytokine</keyword>
  <keyword>iPSC</keyword>
  <keyword>Inducible pluripotent stem cell</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>There will be a database/tissue bank for future research</ipd_description>
  </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/NCT03252613
org study id: 1050374
nct id: NCT03252613
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This translational study will assess the association between septic cardiomyopathy (measured
      via left ventricular global longitudinal strain) and (a) inflammatory cytokine profiles, and
      (b) the behavior of cardiomyocytes derived from inducible pluripotent stem cells.
observational model: Cohort
time perspective: Prospective
measure: Correlation of cytokine profile with left ventricular global longitudinal strain
time frame: Day 1
description: This outcome assesses the correlation between inflammatory cytokines (summarized via PCA) and septic cardiomyopathy, as assessed by left ventricular global longitudinal strain.
measure: Adrenergic susceptibility of pluripotent stem cell-derived cardiomyocytes
time frame: Day 1
description: This is a laboratory-based outcome, using pluripotent stem cell-derived cardiomyocytes, with exposure to adrenergic agonists and antagonists in vitro
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Samuel Brown, MD
role: Principal Investigator
affiliation: Intermountain Health Care, Inc.
last name: Euan Ashley, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Intermountain Health Care, Inc.
investigator full name: Samuel Brown
investigator title: Principal Investigator
mesh term: Cardiomyopathies
sharing ipd: Yes
ipd description: There will be a database/tissue bank for future research