<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/NCT02232048</url>
  </required_header>
  <id_info>
    <org_study_id>0061-14-HYMC</org_study_id>
    <nct_id>NCT02232048</nct_id>
  </id_info>
  <brief_title>The Influence of Corticosteroid Treatment on Heart Function</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients hospitalized in internal medicine departments are given corticosteroid treatment&#xD;
      according clinical indications. Patients receive treatment at different dosage levels and in&#xD;
      different preparations according to clinical indications. This study will investigate how&#xD;
      corticosteroids effect the heart and specifically, longitudinal strain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">September 2016</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>Change in Heart Function</measure>
    <time_frame>Two years</time_frame>
    <description>Heart contraction and specifically its longitudinal strain will be examined using Transthoracic Echocardiogram (TTE) before, during and after corticosteroid treatment. TTE reveals changes in contraction in the right and left ventricle and septum.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Myocardial Function</condition>
  <arm_group>
    <arm_group_label>Corticosteroid Treatment</arm_group_label>
    <description>Patients in the internal medicine department who are being treated with corticosteroids will undergo Transthoracic Echocardiogram to determine change in heart function.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transthoracic Echocardiogram</intervention_name>
    <arm_group_label>Corticosteroid Treatment</arm_group_label>
    <other_name>Transthoracic Echocardiogram using a VIVID 6 device</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients being treated with corticosteroids for various clinical indications who have been&#xD;
        hospitalized in the internal medicine department of the Hillel Yaffe Medical Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stable patients able to undergo Transthoracic Echocardiogram&#xD;
&#xD;
          -  Patients beginning treatment with corticosteroids&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Patients recently or chronically treated with corticosteroids&#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_contact>
    <last_name>Nina Avshovich, MD</last_name>
    <phone>972-4-630-835</phone>
    <email>ninaa@hy.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Nina Avshovich, MD</last_name>
      <phone>972-4-630-835</phone>
      <email>ninaa@hy.health.gov.il</email>
    </contact>
    <investigator>
      <last_name>Nina Avshovich, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>September 8, 2014</last_update_submitted>
  <last_update_submitted_qc>September 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02232048
org study id: 0061-14-HYMC
nct id: NCT02232048
lead sponsor: 
has dmc: Yes
Patients hospitalized in internal medicine departments are given corticosteroid treatment
      according clinical indications. Patients receive treatment at different dosage levels and in
      different preparations according to clinical indications. This study will investigate how
      corticosteroids effect the heart and specifically, longitudinal strain.
observational model: Cohort
time perspective: Prospective
measure: Change in Heart Function
time frame: Two years
description: Heart contraction and specifically its longitudinal strain will be examined using Transthoracic Echocardiogram (TTE) before, during and after corticosteroid treatment. TTE reveals changes in contraction in the right and left ventricle and septum.
arm group label: Corticosteroid Treatment
description: Patients in the internal medicine department who are being treated with corticosteroids will undergo Transthoracic Echocardiogram to determine change in heart function.
intervention type: Other
intervention name: Transthoracic Echocardiogram
arm group label: Corticosteroid Treatment
other name: Transthoracic Echocardiogram using a VIVID 6 device
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nina Avshovich, MD
phone: 972-4-630-835
email: ninaa@hy.health.gov.il
facility: 
contact: 
investigator: 
country: Israel
responsible party type: Sponsor