<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/NCT03017157</url>
  </required_header>
  <id_info>
    <org_study_id>0096-16-HYMC</org_study_id>
    <nct_id>NCT03017157</nct_id>
  </id_info>
  <brief_title>Subclinical Hypothyroidism and Acute Anterior Myocardial Infarction: Is it Cardio-protective or Not?</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 study plans to investigate whether recovery of the heart function after acute anterior&#xD;
      myocardial infarction is dependent upon improvement in thyroid gland functioning.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">April 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</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>Ejection Fraction Improvement</measure>
    <time_frame>40 days</time_frame>
    <description>Improvement in ejection fraction as shown in echo-cardiogram</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in thyroid function</measure>
    <time_frame>40 days</time_frame>
    <description>Thyroid stimulating hormone (TSH) level will be normal.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Heart Injuries</condition>
  <arm_group>
    <arm_group_label>Anterior Myocardial Infarction</arm_group_label>
    <description>Patients who have suffered anterior myocardial infarction in our hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Echo-cardiogram</intervention_name>
    <description>Patients will undergo echo-cardiogram to determine improvement in their heart function and this will be compared to thyroid function</description>
    <arm_group_label>Anterior Myocardial Infarction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood test</intervention_name>
    <description>Blood test to determine thyroid function</description>
    <arm_group_label>Anterior Myocardial Infarction</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have suffered anterior myocardial infarction who have been hospitalized in our&#xD;
        hospital's cardiac unit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have suffered anterior myocardial infarction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do not receive thyroid treatment&#xD;
&#xD;
          -  No history of ischemic heart disease&#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>Rami Abo Fane, MD, PhD</last_name>
    <email>ramia@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>Rami Abo Fane, MD, PhD</last_name>
      <email>ramia@hy.health.gov.il</email>
    </contact>
    <investigator>
      <last_name>Rami Abo Fane, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</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>Heart Injuries</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/NCT03017157
org study id: 0096-16-HYMC
nct id: NCT03017157
lead sponsor: 
has dmc: Yes
The study plans to investigate whether recovery of the heart function after acute anterior
      myocardial infarction is dependent upon improvement in thyroid gland functioning.
observational model: Cohort
time perspective: Prospective
measure: Ejection Fraction Improvement
time frame: 40 days
description: Improvement in ejection fraction as shown in echo-cardiogram
measure: Improvement in thyroid function
time frame: 40 days
description: Thyroid stimulating hormone (TSH) level will be normal.
arm group label: Anterior Myocardial Infarction
description: Patients who have suffered anterior myocardial infarction in our hospital
intervention type: Other
intervention name: Echo-cardiogram
description: Patients will undergo echo-cardiogram to determine improvement in their heart function and this will be compared to thyroid function
arm group label: Anterior Myocardial Infarction
intervention type: Other
intervention name: Blood test
description: Blood test to determine thyroid function
arm group label: Anterior Myocardial Infarction
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rami Abo Fane, MD, PhD
email: ramia@hy.health.gov.il
facility: 
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Heart Injuries
sharing ipd: No