<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/NCT03799185</url>
  </required_header>
  <id_info>
    <org_study_id>ID5726367</org_study_id>
    <nct_id>NCT03799185</nct_id>
  </id_info>
  <brief_title>Dyslipidemia Prevalence, Perception, Treatment, and Awareness in the Tunisian Population</brief_title>
  <acronym>ATERASurvey</acronym>
  <official_title>Dyslipidemia Prevalence, Perception, Treatment, and Awareness in the Tunisian Population : The ATERA Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association Tunisienne d'Etude &amp; de Recherche sur l'Athérosclérose</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biochimie Clinique LR99ES11</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Biochemistry, La Rabta Hospital, Tunisia.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, Tunisia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Interior, Tunisia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Direction des Soins de Santé de Base</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Statistics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Public Health of Tunisia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dacima Consulting</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Association Tunisienne d'Etude &amp; de Recherche sur l'Athérosclérose</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>
      ATERA Survey is a national cross sectional observational study, aiming to determine the&#xD;
      prevalence of dyslipidemia and other conventional risk factors for CHD (Coronary Heart&#xD;
      Disease), the relationship between environmental and lifestyle factors with dyslipidemia, the&#xD;
      perception and the knowledge of cardiovascular risk factors by the population, and above all,&#xD;
      to strengthen the national strategy for primary and secondary prevention against coronary&#xD;
      heart disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ATERA Survey is carried on in a random sampling including 10 000 men and women from the seven&#xD;
      regions of Tunisia (Great Tunis, North East, North West, central East, Central West, South&#xD;
      East and South West. The screening is being assessed using surveys covering socioeconomic,&#xD;
      nutritional and anthropometric measures in addition to biological assessments.&#xD;
&#xD;
      The target population is being recruited by random sampling drown by the National Institute&#xD;
      of Statistics (Tunisia). The estimated number of participants at the end of recruitment&#xD;
      amount to 10 000. The frame sampling uses a two stage cluster sampling (district and&#xD;
      household).&#xD;
&#xD;
      Interview with each eligible participant will be conducted mainly during assessment visit and&#xD;
      after consenting the subject, it will be notified all the demographic, behavioral history,&#xD;
      family history, cardiovascular risk factors and medical history. During the assessment visit,&#xD;
      Physical examination/anthropometry data and Diet survey will be filled up by the&#xD;
      investigator.&#xD;
&#xD;
      Data capture will be performed by the DACIMA Clinical Suite according to FDA 21 CFR part 11&#xD;
      requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA&#xD;
      specifications (Health Insurance Portability and Accountability Act), and the ICH standards&#xD;
      (International Conference on Harmonisation)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2016</start_date>
  <completion_date type="Actual">August 31, 2019</completion_date>
  <primary_completion_date type="Actual">August 31, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Family-Based</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Prevalence of dyslipidemia</measure>
    <time_frame>At inclusion</time_frame>
    <description>Frequency of subjects with hypercholesterolemia and/or hypertriglyceridaemia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of cardiovascular associated risk factors</measure>
    <time_frame>At inclusion</time_frame>
    <description>Frequency of subjects with cardiovascular risk factors (diabetes, hypertension, obesity, gender, smoking)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Dietary assessment</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Frequency of diet daily intake (fat, sugar, proteins, fiber)</description>
  </other_outcome>
  <enrollment type="Actual">13610</enrollment>
  <condition>Dyslipidemias</condition>
  <condition>Atherosclerosis</condition>
  <condition>Households</condition>
  <condition>Survey, Family Life</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All subjects aged between 25 and 75 years who accept to participate at the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prescribed treatment for cancer&#xD;
&#xD;
          -  Organ transplantation&#xD;
&#xD;
          -  Known auto-immune disease&#xD;
&#xD;
          -  Severe liver disease&#xD;
&#xD;
          -  Chronic renal failure&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amani Kallel, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Association Tunisienne d'Etude &amp; de Recherche sur l'Athérosclérose</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Riadh Jemaa, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Association Tunisienne d'Etude &amp; de Recherche sur l'Athérosclérose</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ATERA : Association Tunisienne d'Etude &amp; de Recherche sur l'Athérosclérose</name>
      <address>
        <city>Tunis</city>
        <zip>1007</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <link>
    <url>http://atera1.org</url>
    <description>ATERA official Website</description>
  </link>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 17, 2020</last_update_submitted>
  <last_update_submitted_qc>January 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary Heart Disease</keyword>
  <keyword>Hypercholesterolemia</keyword>
  <keyword>Triglycerides High</keyword>
  <keyword>LDL Hyperlipoproteinemia</keyword>
  <keyword>HDL Low</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Cardiovascular Diseases</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Risk Factor, Cardiovascular</keyword>
  <keyword>Diet Habit</keyword>
  <keyword>Smoking</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>CSR (Clinical Study Report)</ipd_description>
  </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/NCT03799185
org study id: ID5726367
nct id: NCT03799185
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
ATERA Survey is a national cross sectional observational study, aiming to determine the
      prevalence of dyslipidemia and other conventional risk factors for CHD (Coronary Heart
      Disease), the relationship between environmental and lifestyle factors with dyslipidemia, the
      perception and the knowledge of cardiovascular risk factors by the population, and above all,
      to strengthen the national strategy for primary and secondary prevention against coronary
      heart disease.
ATERA Survey is carried on in a random sampling including 10 000 men and women from the seven
      regions of Tunisia (Great Tunis, North East, North West, central East, Central West, South
      East and South West. The screening is being assessed using surveys covering socioeconomic,
      nutritional and anthropometric measures in addition to biological assessments.

      The target population is being recruited by random sampling drown by the National Institute
      of Statistics (Tunisia). The estimated number of participants at the end of recruitment
      amount to 10 000. The frame sampling uses a two stage cluster sampling (district and
      household).

      Interview with each eligible participant will be conducted mainly during assessment visit and
      after consenting the subject, it will be notified all the demographic, behavioral history,
      family history, cardiovascular risk factors and medical history. During the assessment visit,
      Physical examination/anthropometry data and Diet survey will be filled up by the
      investigator.

      Data capture will be performed by the DACIMA Clinical Suite according to FDA 21 CFR part 11
      requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA
      specifications (Health Insurance Portability and Accountability Act), and the ICH standards
      (International Conference on Harmonisation)
observational model: Family-Based
time perspective: Cross-Sectional
measure: Prevalence of dyslipidemia
time frame: At inclusion
description: Frequency of subjects with hypercholesterolemia and/or hypertriglyceridaemia
measure: Prevalence of cardiovascular associated risk factors
time frame: At inclusion
description: Frequency of subjects with cardiovascular risk factors (diabetes, hypertension, obesity, gender, smoking)
measure: Dietary assessment
time frame: Up to 1 month
description: Frequency of diet daily intake (fat, sugar, proteins, fiber)
Serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amani Kallel, PhD
role: Study Chair
affiliation: Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
last name: Riadh Jemaa, PhD
role: Study Chair
affiliation: Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
facility: 
country: Tunisia
url: http://atera1.org
description: ATERA official Website
responsible party type: Sponsor
mesh term: Atherosclerosis
mesh term: Dyslipidemias
sharing ipd: Undecided
ipd description: CSR (Clinical Study Report)