<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/NCT02237794</url>
  </required_header>
  <id_info>
    <org_study_id>0049-14-HYMC</org_study_id>
    <nct_id>NCT02237794</nct_id>
  </id_info>
  <brief_title>Effect of Medical Treatment on Longitudinal Function of the Heart</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>
      The purpose of this study is to determine the effect of medical treatment on longitudinal&#xD;
      myocardial function. Patients who have been hospitalized for reasons other than heart disease&#xD;
      will be examined with Transthoracic Cardiography before and after medical treatment to&#xD;
      determine change in myocardial function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">October 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Longitudinal Myocardial Function</measure>
    <time_frame>Two Years</time_frame>
    <description>Analysis of longitudinal contractility of the heart by the calculation of the heart's strain factor before and after chronic medication treatment.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Heart Function</condition>
  <arm_group>
    <arm_group_label>Patients Without Acute Heart Conditions</arm_group_label>
    <description>Patients without acute heart conditions who were hospitalized for other medical indications.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients hospitalized in an Internal Medicine Department of the Hillel Yaffe Medical Center&#xD;
        having a variety of medical conditions and treated with a variety of medications including&#xD;
        Beta Blockers, Calcium Channel Blockers, Angiotensine Converting Enzyme Inhibitors and&#xD;
        diuretics and do not suffer from overt heart conditions.&#xD;
&#xD;
        --------------------------------------------------------------------------------&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized patients receiving above-mentioned medications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from heart conditions&#xD;
&#xD;
          -  Patients unable to undergo Echocardiography&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Blondheim, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Said Younis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Said Younis, MD</last_name>
    <phone>972-5-446-66274</phone>
    <email>saidjy@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <investigator>
      <last_name>Said Younis, 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>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 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/NCT02237794
org study id: 0049-14-HYMC
nct id: NCT02237794
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine the effect of medical treatment on longitudinal
      myocardial function. Patients who have been hospitalized for reasons other than heart disease
      will be examined with Transthoracic Cardiography before and after medical treatment to
      determine change in myocardial function.
time perspective: Prospective
measure: Longitudinal Myocardial Function
time frame: Two Years
description: Analysis of longitudinal contractility of the heart by the calculation of the heart's strain factor before and after chronic medication treatment.
arm group label: Patients Without Acute Heart Conditions
description: Patients without acute heart conditions who were hospitalized for other medical indications.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: David Blondheim, MD
role: Study Chair
affiliation: Hillel Yaffe Medical Center
last name: Said Younis, MD
role: Principal Investigator
affiliation: Hillel Yaffe Medical Center
last name: Said Younis, MD
phone: 972-5-446-66274
email: saidjy@gmail.com
facility: 
investigator: 
country: Israel
responsible party type: Sponsor