<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/NCT03813017</url>
  </required_header>
  <id_info>
    <org_study_id>0123-18-ZIV</org_study_id>
    <nct_id>NCT03813017</nct_id>
  </id_info>
  <brief_title>Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis</brief_title>
  <official_title>Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ziv Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ziv Hospital</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>
      Cardiovascular disease is a leading cause for morbidity and mortality in general population.&#xD;
      The incidence of cardiovascular disease and their poor outcome is well documented in a broad&#xD;
      spectrum of connective tissue diseases, especially in rheumatoid arthritis (RA). The risk of&#xD;
      incident CVD is increased by 48% in patients with RA compared to the general population.&#xD;
&#xD;
      RA is associated with 50% increase in the mortality in patients with cardiovascular disease&#xD;
      (CVD). One reason is the more frequent cardiovascular risk factors in RA patients compared&#xD;
      with the general population. Patients with RA have a high risk of premature cardiovascular&#xD;
      disease (CVD). The aim of the present study is to assess whether there are non-invasive&#xD;
      measures that might predict arteriosclerosis in RA patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2019</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Cardiovascular disease risks in patient with theumatoid arthritis</measure>
    <time_frame>6 months</time_frame>
    <description>Prediction of cardiovascular risks and proposed preventive treatment</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Atherosclerosis, Coronary</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This study will be conducted in Ziv Medical Center, Safed, Internal Medicine Department A,&#xD;
        on 100 patients with rheumatoid artheritis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18-70 years old (except for women till 75 years old)&#xD;
&#xD;
          2. Absence of established CVD:&#xD;
&#xD;
               -  Myocardial Infarction p/h&#xD;
&#xD;
               -  PCI with balloon and/or stent&#xD;
&#xD;
               -  Intermittent claudication&#xD;
&#xD;
               -  PAD / intervention&#xD;
&#xD;
               -  CAS /intervention&#xD;
&#xD;
          3. Signed informed consent form&#xD;
&#xD;
          4. Documented diagnosis of rheumatoid arthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known CVD&#xD;
&#xD;
          2. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Naaem Simaan, Dr</last_name>
    <phone>+972523675305</phone>
    <email>naaem.s@ziv.health.gov.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Karine Beiruti, PhD</last_name>
    <phone>+972528082424</phone>
    <email>karine.b@ziv.health.gov.il</email>
  </overall_contact_backup>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>July 9, 2019</last_update_submitted>
  <last_update_submitted_qc>July 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ziv Hospital</investigator_affiliation>
    <investigator_full_name>Osamah Hussein</investigator_full_name>
    <investigator_title>Head of Internal Medicine A</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03813017
org study id: 0123-18-ZIV
nct id: NCT03813017
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiovascular disease is a leading cause for morbidity and mortality in general population.
      The incidence of cardiovascular disease and their poor outcome is well documented in a broad
      spectrum of connective tissue diseases, especially in rheumatoid arthritis (RA). The risk of
      incident CVD is increased by 48% in patients with RA compared to the general population.

      RA is associated with 50% increase in the mortality in patients with cardiovascular disease
      (CVD). One reason is the more frequent cardiovascular risk factors in RA patients compared
      with the general population. Patients with RA have a high risk of premature cardiovascular
      disease (CVD). The aim of the present study is to assess whether there are non-invasive
      measures that might predict arteriosclerosis in RA patients.
observational model: Cohort
time perspective: Prospective
measure: Cardiovascular disease risks in patient with theumatoid arthritis
time frame: 6 months
description: Prediction of cardiovascular risks and proposed preventive treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Naaem Simaan, Dr
phone: +972523675305
email: naaem.s@ziv.health.gov.il
last name: Karine Beiruti, PhD
phone: +972528082424
email: karine.b@ziv.health.gov.il
responsible party type: Principal Investigator
investigator affiliation: Ziv Hospital
investigator full name: Osamah Hussein
investigator title: Head of Internal Medicine A
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Cardiovascular Diseases
mesh term: Atherosclerosis
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia