<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/NCT04487223</url>
  </required_header>
  <id_info>
    <org_study_id>6500-19-SMC</org_study_id>
    <nct_id>NCT04487223</nct_id>
  </id_info>
  <brief_title>Characterization of Novel Lipoprotein Properties Associated With an Increased Risk to Develop Atherosclerosis</brief_title>
  <official_title>Characterization of Novel Lipoprotein Properties Associated With an Increased Risk to Develop Atherosclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</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>
      Objectives of Medical Research:&#xD;
&#xD;
      Separation of LDL and HDL from blood samples of patients with high LDL and / or low HDL who&#xD;
      have developed atherosclerotic disease with similar patients who have no evidence of&#xD;
      atherosclerosis.&#xD;
&#xD;
      Lipidomics and proteomics will examine whether there is a difference in lipid and protein&#xD;
      composition and lipoprotein composition. If there are any changes in expression level or the&#xD;
      composition of proteins or metabolites that make up lipoproteins, the investigator will try&#xD;
      to figure out the mechanism responsible for these changes and their role in the metabolic&#xD;
      process. the investigator will seek therapeutic measures through which these mechanisms can&#xD;
      be inhibited and thus inhibit the development of sclerosis or even retraction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants:&#xD;
&#xD;
      Participants who are found suitable during their visit to the Lipid Institute Clinic or&#xD;
      during hospitalization at the Sheba Medical Center will receive an explanation of the study,&#xD;
      will be asked to sign a consent form.&#xD;
&#xD;
      A medical history will be taken, the participant will be asked to fill out a nutrition&#xD;
      questionnaire (FFQ) and a 5 cc blood sample will be taken from each patient&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 27, 2020</start_date>
  <completion_date type="Anticipated">April 27, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 27, 2022</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>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Characterization of novel lipoprotein properties associated with an increased risk to develop atherosclerosis</measure>
    <time_frame>1 year</time_frame>
    <description>Lipoproteins would be analyzed by lipidomic and proteomic profiling using chromatography and mass-spectrometry. Concentrations of specific lipids and proteins will be quantified as micrograms per deciliter or as area under the curve. We will look for significant differences in these values between the different study groups using updated software tools specifically designed for mass spectrometry data analysis.</description>
  </primary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Atherosclerosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be conducted at the Sheba Medical Center's Lipid Institute, participants&#xD;
        will be the Lipid Institute's patients Number of participants: 20 patients with&#xD;
        hypercholesterolemia and sclerosis, 20 patients with hypercholesterolemia without evidence&#xD;
        of sclerosis, 20 healthy participants as a control group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy participants with LDL levels less than 130 mg / dl without evidence of&#xD;
             atherosclerosis or wall thickening of the carotid artery according to an ultrasound&#xD;
             imaging of the carotid artery at the Lipid Institute and unknown for atherosclerosis&#xD;
             or cardiovascular disease in the background.&#xD;
&#xD;
          -  Participants with LDL levels above 160 mg / dl, with no evidence of atherosclerosis or&#xD;
             wall thickening of the carotid artery according to an ultrasound - IMT of the carotid&#xD;
             arteries performed at the Lipid Institute and unknown for atherosclerosis or&#xD;
             cardiovascular disease in the background.&#xD;
&#xD;
          -  Participants with LDL levels above 160 mg / dl, where evidence of atherosclerosis or&#xD;
             wall thickening of the arteries can be found by ultrasound imaging of the carotid&#xD;
             artery that is performed at the Lipid Institute or known for atherosclerosis or&#xD;
             cardiovascular disease in the background.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with triglyceride values above 300 mg%, HDL lower than 30 mg%, APOB greater&#xD;
             than 150 mg% or LPa higher than 70 mg% will not be included in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Tamar Luvish, BSN</last_name>
    <phone>972-35303492</phone>
    <email>tamar.luvish@sheba.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lipid center</name>
      <address>
        <city>Tel HaShomer</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>tamar luvish, BSN</last_name>
      <phone>972-35303492</phone>
      <email>tamar.luvish@sheba.health.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>September 26, 2021</last_update_submitted>
  <last_update_submitted_qc>September 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Rom Keshet</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</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/NCT04487223
org study id: 6500-19-SMC
nct id: NCT04487223
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objectives of Medical Research:

      Separation of LDL and HDL from blood samples of patients with high LDL and / or low HDL who
      have developed atherosclerotic disease with similar patients who have no evidence of
      atherosclerosis.

      Lipidomics and proteomics will examine whether there is a difference in lipid and protein
      composition and lipoprotein composition. If there are any changes in expression level or the
      composition of proteins or metabolites that make up lipoproteins, the investigator will try
      to figure out the mechanism responsible for these changes and their role in the metabolic
      process. the investigator will seek therapeutic measures through which these mechanisms can
      be inhibited and thus inhibit the development of sclerosis or even retraction.
Participants:

      Participants who are found suitable during their visit to the Lipid Institute Clinic or
      during hospitalization at the Sheba Medical Center will receive an explanation of the study,
      will be asked to sign a consent form.

      A medical history will be taken, the participant will be asked to fill out a nutrition
      questionnaire (FFQ) and a 5 cc blood sample will be taken from each patient
observational model: Cohort
time perspective: Other
measure: Characterization of novel lipoprotein properties associated with an increased risk to develop atherosclerosis
time frame: 1 year
description: Lipoproteins would be analyzed by lipidomic and proteomic profiling using chromatography and mass-spectrometry. Concentrations of specific lipids and proteins will be quantified as micrograms per deciliter or as area under the curve. We will look for significant differences in these values between the different study groups using updated software tools specifically designed for mass spectrometry data analysis.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tamar Luvish, BSN
phone: 972-35303492
email: tamar.luvish@sheba.health.gov.il
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Dr. Rom Keshet
investigator title: Principal Investigator
mesh term: Atherosclerosis