<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/NCT04416425</url>
  </required_header>
  <id_info>
    <org_study_id>ZiboCH</org_study_id>
    <nct_id>NCT04416425</nct_id>
  </id_info>
  <brief_title>Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment</brief_title>
  <official_title>Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment: A Serial Follow-Up Study by Computed Tomography-Derived Fractional Flow Reserve</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>
      Compelling evidences indicate that lipid-lowering therapy can reduce the high-risk plaque&#xD;
      feathers and improve the coronary flow reserve. This study is going to investigate the change&#xD;
      of lesion-specific hemodynamic significance as determined by ML(Machine Learning)-based&#xD;
      CT-FFR (Computed Tomography-Fractional Flow Reserve)after Evolocumab treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 30, 2021</start_date>
  <completion_date type="Anticipated">February 27, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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 change of lesion-specific CT-FFR</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 CCTA again. We will measure the proximal and distal CT-FFR for each lesion.At the same time ,we will calculated the change in CT-FFR value across the lesion(ΔCT-FFR=CT-FFRproximal-CT-FFRdistal).To compare the parameters above,we shall identify whether the treatment of Elovocumab Injection improves the lesion-specific CT-FFR.</description>
  </primary_outcome>
  <other_outcome>
    <measure>the change of minimal lumen diameter between baseline and follow-up CCTA</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 CCTA again. We will measure the minimal lumen diameter for each lesion. Minimal lumen diameter will be manually measured with a digital caliper at the narrowest level of the lesion using the crosssectional images accroding to the CCTA findings. The results of the minimal lumen diameter at baseline will be compared with results obtained during follow-up to examine the effects of Elovocumab Injection therapy.</description>
  </other_outcome>
  <other_outcome>
    <measure>the change of total plaque volume (TPV) between baseline and follow-up CCTA</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 CCTA again. We will measure TPV for each lesion. Total plaque volume will be automatically measured using the dedicated plaque analysis software. The results of TPV at baseline will be compared with results obtained during follow-up to examine the effects of Elovocumab Injection therapy.</description>
  </other_outcome>
  <other_outcome>
    <measure>the change of lesion length between baseline and follow-up CCTA</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 CCTA again. The length of lesion at baseline will be compared with results obtained during follow-up to examine the effects of Elovocumab Injection therapy.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>Enrolled Cohort</arm_group_label>
    <description>200 selected patients will be recruited, who have diagnosed with coronary atherosclerosis disease(stenotic extent from 50% to 69% on major epicardial arteries) by coronary computed tomography angiography(CCTA). Every two weeks, these patients will be treated with Elococumab Injection (1ml:140mg),ih.This therapy will last for one year.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 200 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.baseline CCTA revealed at least one lesion with stenotic extent from 50% to 69% on&#xD;
             major epicardial arteries (diameter ≧2 mm);&#xD;
&#xD;
          -  2.patients were referred for optimal medical treatment;&#xD;
&#xD;
          -  3.patients agreed to undergo follow-up CCTA at 1-year interval.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1.patients had previous history of myocardial infarction or coronary&#xD;
             revascularization;&#xD;
&#xD;
          -  2.patients were contraindicated to the usage of iodine contrast media;&#xD;
&#xD;
          -  3.image quality of baseline or follow-up CCTA 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 cardiac events during follow-up;&#xD;
&#xD;
          -  6.patients refused to undergo follow-up CCTA;&#xD;
&#xD;
          -  7.lost follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bo Li, Doctor</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>
    <contact>
      <last_name>Bo Li</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 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>Atherosclerosis</mesh_term>
    <mesh_term>Plaque, Atherosclerotic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04416425
org study id: ZiboCH
nct id: NCT04416425
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Compelling evidences indicate that lipid-lowering therapy can reduce the high-risk plaque
      feathers and improve the coronary flow reserve. This study is going to investigate the change
      of lesion-specific hemodynamic significance as determined by ML(Machine Learning)-based
      CT-FFR (Computed Tomography-Fractional Flow Reserve)after Evolocumab treatment.
observational model: Cohort
time perspective: Prospective
measure: the change of lesion-specific CT-FFR
time frame: June 2020 to December 2021
description: After one year's treatment of Elovocumab Injection, the patients will undergo follow-up CCTA again. We will measure the proximal and distal CT-FFR for each lesion.At the same time ,we will calculated the change in CT-FFR value across the lesion(ΔCT-FFR=CT-FFRproximal-CT-FFRdistal).To compare the parameters above,we shall identify whether the treatment of Elovocumab Injection improves the lesion-specific CT-FFR.
measure: the change of minimal lumen diameter between baseline and follow-up CCTA
time frame: June 2020 to December 2021
description: After one year's treatment of Elovocumab Injection, the patients will undergo follow-up CCTA again. We will measure the minimal lumen diameter for each lesion. Minimal lumen diameter will be manually measured with a digital caliper at the narrowest level of the lesion using the crosssectional images accroding to the CCTA findings. The results of the minimal lumen diameter at baseline will be compared with results obtained during follow-up to examine the effects of Elovocumab Injection therapy.
measure: the change of total plaque volume (TPV) between baseline and follow-up CCTA
time frame: June 2020 to December 2021
description: After one year's treatment of Elovocumab Injection, the patients will undergo follow-up CCTA again. We will measure TPV for each lesion. Total plaque volume will be automatically measured using the dedicated plaque analysis software. The results of TPV at baseline will be compared with results obtained during follow-up to examine the effects of Elovocumab Injection therapy.
measure: the change of lesion length between baseline and follow-up CCTA
time frame: June 2020 to December 2021
description: After one year's treatment of Elovocumab Injection, the patients will undergo follow-up CCTA again. The length of lesion at baseline will be compared with results obtained during follow-up to examine the effects of Elovocumab Injection therapy.
arm group label: Enrolled Cohort
description: 200 selected patients will be recruited, who have diagnosed with coronary atherosclerosis disease(stenotic extent from 50% to 69% on major epicardial arteries) by coronary computed tomography angiography(CCTA). Every two weeks, these patients will be treated with Elococumab Injection (1ml:140mg),ih.This therapy will last for one year.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Bo Li, Doctor
role: Principal Investigator
affiliation: Zibo Central Hospital
last name: Bo Li, Doctor
phone: +86-18560292371
email: libosubmit@163.com
facility: 
contact: 
country: China
responsible party type: Sponsor
mesh term: Atherosclerosis
mesh term: Plaque, Atherosclerotic
sharing ipd: Undecided