xml: <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/NCT05980923</url>
    </required_header>
    <id_info>
      <org_study_id>DCR2023/1.ThyrAcuteIll</org_study_id>
      <nct_id>NCT05980923</nct_id>
    </id_info>
    <brief_title>Thyroid Profiles in Patients With Acute Illness</brief_title>
    <official_title>Thyroid Profiles in Middle Eastern Patients Admitted With Acute Illness: Prevalence, Clinical Features and Impact on Mortality</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jordan Collaborating Cardiology Group</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jordan Collaborating Cardiology Group</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>
        Patients admitted to the hospital with acute illness may have a wide spectrum of thyroid&#xD;
        function abnormalities. It is largely unknown whether such aberrations are temporary or&#xD;
        persist for a long time, and whether they impact prognosis of such patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Recently, there has been a growing body of evidence that subclinical thyroid dysfunction as a&#xD;
        contributor to the increase of cardiovascular events. Elevated serum thyroid-stimulating&#xD;
        hormone (TSH) levels and normal free thyroxine (FT4) and free triiodothyronine (FT3) levels&#xD;
        have been associated with worse heart failure and dyslipidemia. Furthermore, higher risk of&#xD;
        atrial fibrillation has been linked tp thyroid abnormalities in these patients.&#xD;
  &#xD;
        Patients admitted to the hospital with acute illness may have a wide spectrum of thyroid&#xD;
        function abnormalities. It is largely unknown whether such aberrations are temporary or&#xD;
        persist for a long time, and whether they impact prognosis of such patients. This study aimed&#xD;
        at evaluating the prevalence of thyroid function abnormalities in patients admitted to&#xD;
        hospital with acute illness and their temporal changes and impact on mortality during&#xD;
        hospitalization and at 1 year. Serum level of thyroid stimulating hormone and free T4 and T3&#xD;
        measured on admission. Clinical and laboratory profiles of patients with abnormal thyroid&#xD;
        function (ATF group) will be compared to those with normal thyroid function (NTF group).&#xD;
        Short and long term survival of both groups were compares as well.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 15, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>In hospital mortality</measure>
      <time_frame>From time of study entry until the date of death from any cause, assessed up to 2 weeks.</time_frame>
      <description>All-cause death rate in patients with abnormal thyroid function compared with death in those with no abnormal thyroid function during the patients hospital stay..</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>6-month mortality rate</measure>
      <time_frame>From date of study entry until the date of death from any cause, assessed up to two weeks.</time_frame>
      <description>All-cause death rate in patients with abnormal thyroid function compared with death in those with no abnormal thyroid function at 6 months.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Thyroid Dysfunction</condition>
    <condition>Acute Illness</condition>
    <arm_group>
      <arm_group_label>GROUP 1: Acute illness and abnormal thyroid function</arm_group_label>
      <description>Patients admitted to the hospital with acute illness and found to have thyroid function abnormalities.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>GROUP 2: Acute illness and normal thyroid function</arm_group_label>
      <description>Patients admitted to the hospital with acute illness and found to have normal thyroid function.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Performing blood thyroid test (TSH, FT4, FT3)</intervention_name>
      <description>Blood test as above</description>
      <arm_group_label>GROUP 1: Acute illness and abnormal thyroid function</arm_group_label>
      <arm_group_label>GROUP 2: Acute illness and normal thyroid function</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          nclusion Criteria: All patients admitted to the hospital with acute illness will have their&#xD;
          serum level of thyroid stimulating hormone and free T4 and T3 measured on admission.&#xD;
          Clinical and laboratory profiles of patients with abnormal thyroid function (Group 1) will&#xD;
          be compared to those with normal thyroid function (Group 2). Serum thyroid test will be&#xD;
          repeated at 6 months. Short and long term survival of both groups will be compared as well.&#xD;
  &#xD;
          Diagnosis on admission is acute illness includes: heart failure, acute coronary syndrome,&#xD;
          sepsis, acute stroke, hypotension, acute system-organ failure including renal and hepatic&#xD;
          failure.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Hospital admission&#xD;
  &#xD;
            -  Adults aged 18 years and above&#xD;
  &#xD;
            -  Willing to sign an informed consent&#xD;
  &#xD;
            -  Diagnosis on admission is acute illness that includes: heart failure, acute coronary&#xD;
               syndrome, sepsis, acute stroke, hypotension, acute system-organ failure including&#xD;
               renal and hepatic failure.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age less than 18 years.&#xD;
  &#xD;
            -  Refusal to sign consent.&#xD;
  &#xD;
            -  Admission for a reason not classified as acute illness.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Ayman J Hammoudeh, MD, FACC</last_name>
      <phone>0096265001000</phone>
      <phone_ext>266</phone_ext>
      <email>a.hammoudeh@istisharihospital.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Enas Younes, MD</last_name>
      <phone>0096265001000</phone>
      <phone_ext>267</phone_ext>
      <email>researchculture2020@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Istishari Hospital</name>
        <address>
          <city>Amman</city>
          <zip>11888</zip>
          <country>Jordan</country>
        </address>
      </facility>
      <contact>
        <last_name>Enas Younes, MD</last_name>
        <phone>0096265001000</phone>
        <phone_ext>367</phone_ext>
        <email>researchculture2020@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Jordan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Thyroid abnormalities</keyword>
    <keyword>Acute illness</keyword>
    <keyword>Prognosis</keyword>
    <keyword>Middle east</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thyroid Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Will contact other ICU physicians in the city of Amman to invite them to participate in the study</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980923
  org study id: DCR2023/1.ThyrAcuteIll
  nct id: NCT05980923
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients admitted to the hospital with acute illness may have a wide spectrum of thyroid
        function abnormalities. It is largely unknown whether such aberrations are temporary or
        persist for a long time, and whether they impact prognosis of such patients.
  Recently, there has been a growing body of evidence that subclinical thyroid dysfunction as a
        contributor to the increase of cardiovascular events. Elevated serum thyroid-stimulating
        hormone (TSH) levels and normal free thyroxine (FT4) and free triiodothyronine (FT3) levels
        have been associated with worse heart failure and dyslipidemia. Furthermore, higher risk of
        atrial fibrillation has been linked tp thyroid abnormalities in these patients.
  
        Patients admitted to the hospital with acute illness may have a wide spectrum of thyroid
        function abnormalities. It is largely unknown whether such aberrations are temporary or
        persist for a long time, and whether they impact prognosis of such patients. This study aimed
        at evaluating the prevalence of thyroid function abnormalities in patients admitted to
        hospital with acute illness and their temporal changes and impact on mortality during
        hospitalization and at 1 year. Serum level of thyroid stimulating hormone and free T4 and T3
        measured on admission. Clinical and laboratory profiles of patients with abnormal thyroid
        function (ATF group) will be compared to those with normal thyroid function (NTF group).
        Short and long term survival of both groups were compares as well.
  observational model: Case-Only
  time perspective: Prospective
  measure: In hospital mortality
  time frame: From time of study entry until the date of death from any cause, assessed up to 2 weeks.
  description: All-cause death rate in patients with abnormal thyroid function compared with death in those with no abnormal thyroid function during the patients hospital stay..
  measure: 6-month mortality rate
  time frame: From date of study entry until the date of death from any cause, assessed up to two weeks.
  description: All-cause death rate in patients with abnormal thyroid function compared with death in those with no abnormal thyroid function at 6 months.
  arm group label: GROUP 1: Acute illness and abnormal thyroid function
  description: Patients admitted to the hospital with acute illness and found to have thyroid function abnormalities.
  arm group label: GROUP 2: Acute illness and normal thyroid function
  description: Patients admitted to the hospital with acute illness and found to have normal thyroid function.
  intervention type: Other
  intervention name: Performing blood thyroid test (TSH, FT4, FT3)
  description: Blood test as above
  arm group label: GROUP 1: Acute illness and abnormal thyroid function
  arm group label: GROUP 2: Acute illness and normal thyroid function
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Ayman J Hammoudeh, MD, FACC
  phone: 0096265001000
  phone ext: 266
  email: a.hammoudeh@istisharihospital.com
  last name: Enas Younes, MD
  phone: 0096265001000
  phone ext: 267
  email: researchculture2020@gmail.com
  facility: 
  contact: 
  country: Jordan
  responsible party type: Sponsor
  mesh term: Thyroid Diseases
  sharing ipd: Undecided
  ipd description: Will contact other ICU physicians in the city of Amman to invite them to participate in the study