<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/NCT03247153</url>
  </required_header>
  <id_info>
    <org_study_id>HYMC-52-17</org_study_id>
    <nct_id>NCT03247153</nct_id>
  </id_info>
  <brief_title>Influence of Corticosteroids on Heart Function</brief_title>
  <official_title>Influence of Corticosteroid Therapy on Heart Function</official_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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the effect of corticosteroid treatment on heart function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2017</start_date>
  <completion_date type="Anticipated">August 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in heart function</measure>
    <time_frame>One month after completion of treatment</time_frame>
    <description>Comparison of echocardiography performed before, during, and after corticosteroid administration will display changes in heart function</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Heart; Complications</condition>
  <arm_group>
    <arm_group_label>Corticosteroid Therapy Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Corticosteroid therapy patients will be examined by echocardiography before, during and after receiving treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Echocardiography</intervention_name>
    <description>Imaging of the heart using ultrasound</description>
    <arm_group_label>Corticosteroid Therapy Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with good echogenic body structure&#xD;
&#xD;
          -  Patients with sinus rhythm with no conduction disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with major medical condition&#xD;
&#xD;
          -  Patients who are not hemodynamical stable&#xD;
&#xD;
          -  Patients receiving long-term corticosteroid therapy&#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>Nina Avshovitch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Natalia Kastsyuchenka, MD</last_name>
    <phone>972-630-8350</phone>
    <email>nataluyshkka@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>H̱adera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Natalia Kastsyuchenka, MD</last_name>
      <phone>972-630-8350</phone>
      <email>nataluyshkka@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 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/NCT03247153
org study id: HYMC-52-17
nct id: NCT03247153
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will examine the effect of corticosteroid treatment on heart function.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Changes in heart function
time frame: One month after completion of treatment
description: Comparison of echocardiography performed before, during, and after corticosteroid administration will display changes in heart function
arm group label: Corticosteroid Therapy Patients
arm group type: Experimental
description: Corticosteroid therapy patients will be examined by echocardiography before, during and after receiving treatment
intervention type: Diagnostic Test
intervention name: Echocardiography
description: Imaging of the heart using ultrasound
arm group label: Corticosteroid Therapy Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nina Avshovitch, MD
role: Principal Investigator
affiliation: Hillel Yaffe Medical Center
last name: Natalia Kastsyuchenka, MD
phone: 972-630-8350
email: nataluyshkka@gmail.com
facility: 
contact: 
country: Israel
responsible party type: Sponsor
sharing ipd: No