<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/NCT04494464</url>
  </required_header>
  <id_info>
    <org_study_id>Hypercholesterolemia</org_study_id>
    <nct_id>NCT04494464</nct_id>
  </id_info>
  <brief_title>Treatment Rates and Compliance to Treatment in Patients With Familial Hypercholesterolemia</brief_title>
  <official_title>Awareness, Treatment Rates and Compliance to Treatment in Patients With Serum LDL Cholesterol Higher Than 250 mg/dL, and Possible, Probable or Definite Familial Hypercholesterolemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara Yildirim Beyazıt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara Yildirim Beyazıt University</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>
      Familial hypercholesterolemia is a genetic disease characterized by increased levels of low&#xD;
      density lipoprotein cholesterol (LDL-C). It is underdiagnosed and undertreated despite&#xD;
      relatively high prevalence and significant association with increased mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients older than 18 years old and have a serum low density LDL-C≥250 mg/dL were identified&#xD;
      from the hospital database. A questionnaire was completed via phone. Patients were classified&#xD;
      as definite, probable and possible familial hypercholesterolemia according to Dutch Lipid&#xD;
      Clinical Network Criteria&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Treatment rates</measure>
    <time_frame>January 2010 and December 2016</time_frame>
    <description>Patients with a serum LDL-C≥250 mg/dL were identified from the database of our hospital. Dutch Lipid Clinical Network Criteria was used to classify patients as definite, probable and possible FH. Patients were reached by phone and a questionnaire was applied. The questionnaire consisted of questions related with clinical and physical examination findings defined in theDutch Lipid Clinical Network Criteria. Total cholesterol, LDL-C, HDL-C, triglyceride levels were obtained from the medical records. Patients were asked whether they were using lipid lowering drugs. If they were not using, the cause of this was asked. By this way, we determined the rate of use of lipid lowering drugs in patients with LDL-C≥250 mg/dL and have definite, probable or possible familial hypercholesterolemia</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">367</enrollment>
  <condition>Familial Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>Patients with LDL cholesterol ≥250 mg/dL</arm_group_label>
    <description>Patients older than 18 years old and have a serum LDL-C≥250 mg/dL between January 2010 and December 2016. Patients with a serum TSH≥10 mIU/mL, patients with glomerulonephritis or nephrotic syndrome, patients with ALT or AST higher than 3 times of normal limits and patients with serum triglyceride &gt;400 mg/dL were excluded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <arm_group_label>Patients with LDL cholesterol ≥250 mg/dL</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients older than 18 years old and have a serum LDL-C≥250 mg/dL&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years old and have a serum LDL-C≥250 mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refuse dto interview&#xD;
&#xD;
          -  Serum TSH≥10 mIU/mL&#xD;
&#xD;
          -  Glomerulonephritis or nephrotic syndrome&#xD;
&#xD;
          -  ALT or AST higher than 3 times of normal limits&#xD;
&#xD;
          -  Serum triglyceride &gt;400 mg/dL&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara Yildirim Beyazıt University</investigator_affiliation>
    <investigator_full_name>Didem Ozdemir</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperlipoproteinemia Type II</mesh_term>
    <mesh_term>Hypercholesterolemia</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/NCT04494464
org study id: Hypercholesterolemia
nct id: NCT04494464
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Familial hypercholesterolemia is a genetic disease characterized by increased levels of low
      density lipoprotein cholesterol (LDL-C). It is underdiagnosed and undertreated despite
      relatively high prevalence and significant association with increased mortality.
Patients older than 18 years old and have a serum low density LDL-C≥250 mg/dL were identified
      from the hospital database. A questionnaire was completed via phone. Patients were classified
      as definite, probable and possible familial hypercholesterolemia according to Dutch Lipid
      Clinical Network Criteria
observational model: Case-Only
time perspective: Cross-Sectional
measure: Treatment rates
time frame: January 2010 and December 2016
description: Patients with a serum LDL-C≥250 mg/dL were identified from the database of our hospital. Dutch Lipid Clinical Network Criteria was used to classify patients as definite, probable and possible FH. Patients were reached by phone and a questionnaire was applied. The questionnaire consisted of questions related with clinical and physical examination findings defined in theDutch Lipid Clinical Network Criteria. Total cholesterol, LDL-C, HDL-C, triglyceride levels were obtained from the medical records. Patients were asked whether they were using lipid lowering drugs. If they were not using, the cause of this was asked. By this way, we determined the rate of use of lipid lowering drugs in patients with LDL-C≥250 mg/dL and have definite, probable or possible familial hypercholesterolemia
arm group label: Patients with LDL cholesterol ≥250 mg/dL
description: Patients older than 18 years old and have a serum LDL-C≥250 mg/dL between January 2010 and December 2016. Patients with a serum TSH≥10 mIU/mL, patients with glomerulonephritis or nephrotic syndrome, patients with ALT or AST higher than 3 times of normal limits and patients with serum triglyceride >400 mg/dL were excluded.
intervention type: Other
intervention name: No intervention
arm group label: Patients with LDL cholesterol ≥250 mg/dL
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
responsible party type: Principal Investigator
investigator affiliation: Ankara Yildirim Beyazıt University
investigator full name: Didem Ozdemir
investigator title: Clinical Professor
mesh term: Hyperlipoproteinemia Type II
mesh term: Hypercholesterolemia
sharing ipd: No