<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/NCT04423406</url>
  </required_header>
  <id_info>
    <org_study_id>ZiboCH1</org_study_id>
    <nct_id>NCT04423406</nct_id>
  </id_info>
  <brief_title>The Changes in Carotid Plaque Neovascularization After Elovocumab Therapy</brief_title>
  <official_title>The Changes in Carotid Plaque Neovascularization After Long-term Elovocumab Injection Therapy: A Follow-Up Study by Contrast Enhanced Ultrasonography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zibo Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zibo Central Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      150 selected patients will be recruited, who have at least one atherosclerotic plaque in the&#xD;
      carotid artery that is thicker than 2.0 mm and which is determined to be uniformly or&#xD;
      predominantly echolucent by standard ultrasonography. For each of the plaques, standard&#xD;
      ultrasonography will be used to evaluate lesion echogenicity, while contrast-enhanced&#xD;
      ultrasonography (CEUS) will be used to perform the visual and quantitative analysis of&#xD;
      neovascularization. Each technique will be applied at baseline (at the time of study&#xD;
      enrollment) and following 0.5、1 year of Elococumab Injection treatment. During the study,&#xD;
      these patients will be treated with Elococumab Injection (1ml:140mg),ih, every two weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">February 27, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>The Changes in Carotid Plaque Neovascularization</measure>
    <time_frame>June 2020 to December 2021</time_frame>
    <description>We will use the time-signal intensity curve to calculate the changes in carotid plaque neovascularization.The time-intensity curve parameters includes: Baseline intensity(BI) and peak intensity (PI).Due to the ultrasound contrast agent, the intra-plaque signal intensity increased. Thus, enhanced intensity (EI) was calculated as follows: EI = PI - BI. EI is a parameter that measures the intensity differences between pre- and post-injections of the intravascular tracer. Relative plaque enhancement (EI-R), measured at the separate peak enhancement point in the blood and plaque, will be calculated as the ratio of enhanced intensity in the carotid artery lumen (EI-L) to the enhanced intensity in the plaque (EI-P) using the following formula: EI-R=EI-L/EI-P.</description>
  </primary_outcome>
  <other_outcome>
    <measure>The Changes in Carotid Plaque Size</measure>
    <time_frame>June 2020 to December 2021</time_frame>
    <description>After one year's treatment of Elovocumab Injection, the patients will undergo follow-up standard ultrasonography again. We will measure the size of each lesion.The carotid plaque sizes at pre- and post-elovocumab therapy will be analysed.</description>
  </other_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Carotid Artery Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 150 eligible coronary atherosclerosis disease patients were anticipated to&#xD;
        include in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. have at least one atherosclerotic plaque in the carotid artery that is thicker than&#xD;
             2.0 mm and which is determined to be uniformly or predominantly echolucent by standard&#xD;
             ultrasonography;&#xD;
&#xD;
          -  2.patients were referred for optimal medical treatment;&#xD;
&#xD;
          -  3.patients agreed to undergo follow-up CEUS at half-year and 1-year interval.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1.patients had previous history of cerebral thrombosis or cerebral embolism;&#xD;
&#xD;
          -  2.patients were contraindicated to the usage of contrast media;&#xD;
&#xD;
          -  3.image quality of baseline or follow-up CEUS was severely impaired (in presence of&#xD;
             severe artifact, non-diagnostic);&#xD;
&#xD;
          -  4.patients withdrew the informed consents during follow-up;&#xD;
&#xD;
          -  5.patients experienced major adverse cerebrovascular events during follow-up;&#xD;
&#xD;
          -  6.patients refused to undergo follow-up CEUS;&#xD;
&#xD;
          -  7.lost follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Bo Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zibo Central Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bo Li, Doctor</last_name>
    <phone>+86-18560292371</phone>
    <email>libosubmit@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zibo Central Hospital</name>
      <address>
        <city>Zibo</city>
        <state>Shandong</state>
        <zip>255036</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bo Li, doctor</last_name>
      <phone>86-18560292371</phone>
      <email>libodoc@sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>April 19, 2021</last_update_submitted>
  <last_update_submitted_qc>April 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Artery Diseases</mesh_term>
    <mesh_term>Neovascularization, Pathologic</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/NCT04423406
org study id: ZiboCH1
nct id: NCT04423406
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
150 selected patients will be recruited, who have at least one atherosclerotic plaque in the
      carotid artery that is thicker than 2.0 mm and which is determined to be uniformly or
      predominantly echolucent by standard ultrasonography. For each of the plaques, standard
      ultrasonography will be used to evaluate lesion echogenicity, while contrast-enhanced
      ultrasonography (CEUS) will be used to perform the visual and quantitative analysis of
      neovascularization. Each technique will be applied at baseline (at the time of study
      enrollment) and following 0.5、1 year of Elococumab Injection treatment. During the study,
      these patients will be treated with Elococumab Injection (1ml:140mg),ih, every two weeks.
observational model: Cohort
time perspective: Prospective
measure: The Changes in Carotid Plaque Neovascularization
time frame: June 2020 to December 2021
description: We will use the time-signal intensity curve to calculate the changes in carotid plaque neovascularization.The time-intensity curve parameters includes: Baseline intensity(BI) and peak intensity (PI).Due to the ultrasound contrast agent, the intra-plaque signal intensity increased. Thus, enhanced intensity (EI) was calculated as follows: EI = PI - BI. EI is a parameter that measures the intensity differences between pre- and post-injections of the intravascular tracer. Relative plaque enhancement (EI-R), measured at the separate peak enhancement point in the blood and plaque, will be calculated as the ratio of enhanced intensity in the carotid artery lumen (EI-L) to the enhanced intensity in the plaque (EI-P) using the following formula: EI-R=EI-L/EI-P.
measure: The Changes in Carotid Plaque Size
time frame: June 2020 to December 2021
description: After one year's treatment of Elovocumab Injection, the patients will undergo follow-up standard ultrasonography again. We will measure the size of each lesion.The carotid plaque sizes at pre- and post-elovocumab therapy will be analysed.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
last name: Bo Li
role: Principal Investigator
affiliation: Zibo Central Hospital
last name: Bo Li, Doctor
phone: +86-18560292371
email: libosubmit@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Carotid Artery Diseases
mesh term: Neovascularization, Pathologic