<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/NCT03298282</url>
  </required_header>
  <id_info>
    <org_study_id>1-2017-0049</org_study_id>
    <nct_id>NCT03298282</nct_id>
  </id_info>
  <brief_title>Integrated Coronary Multicenter Imaging Registry</brief_title>
  <official_title>Integrated Coronary Multicenter Imaging Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</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>
      The coronary images of selective angiography and optical coherence tomography with&#xD;
      FFR(Fractional Flow Reserve) values of the intermediate lesions (40-70% stenosis) will be&#xD;
      prospectively registered.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients with intermediate lesions after CT angiography and invasive coronary angiography&#xD;
      will be screened, and optical coherence tomography, FFR and selective CT angiography will be&#xD;
      performed. The coronary images and FFR values will be registered, and the patients will be&#xD;
      followed-up up to 2 years to investigate the adverse clinical events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 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>Change of plaque on coronary CTA for during 2 years</measure>
    <time_frame>at registration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of plaque on coronary CTA for during 2 years</measure>
    <time_frame>at 2-year follow up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of plaque on coronary OCT for during 2 years</measure>
    <time_frame>at registration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of plaque on coronary OCT for during 2 years</measure>
    <time_frame>at 2-year follow up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of FFR value during 2 years</measure>
    <time_frame>at registration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of FFR value during 2 years</measure>
    <time_frame>at 2-year follow up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of computational FFR derived from OCT to invasive FFR</measure>
    <time_frame>at registration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of computational FFR derived from OCT to invasive FFR</measure>
    <time_frame>at 2-year follow up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse event for 2 years (myocardial infarction, cardiovascular death)</measure>
    <time_frame>within 2 years after registration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Power of plaque characteristics on coronary CTA for predicting adverse events</measure>
    <time_frame>within 2 years after registration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Power of plaque characteristics on OCT for predicting adverse events</measure>
    <time_frame>within 2 years after registration</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Imaging Registry</arm_group_label>
    <description>Imaging cohort: Patients with intermediate lesions</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>OCT (Optical Coherence Tomography)</intervention_name>
    <description>Coronary images by OCT and selective CTA and FFR values will be registered.</description>
    <arm_group_label>Imaging Registry</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Coronary CTA</intervention_name>
    <description>Coronary images by OCT and Coronary CTA and FFR values will be registered.</description>
    <arm_group_label>Imaging Registry</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FFR</intervention_name>
    <description>Coronary images by OCT and selective CTA and FFR values will be registered.</description>
    <arm_group_label>Imaging Registry</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Tertiary cardiovascular hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent coronary CT angiography because of chest pain&#xD;
&#xD;
          -  Patients who need OCT or FFR evaluation because of intermediate lesions according to&#xD;
             invasive angiography (diameter stenosis of 40-70%)&#xD;
&#xD;
          -  Age: 20-80 yrs&#xD;
&#xD;
          -  Patients who consent and fully understand the protocol&#xD;
&#xD;
          -  Patients who consent the clinical follow-up&#xD;
&#xD;
          -  Patients who can be followed-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had contrast allergy&#xD;
&#xD;
          -  Patients who had unstable blood pressure needing the vasopressors&#xD;
&#xD;
          -  Patients who had severe left ventricular function (left ventricular ejection&#xD;
             fraction&lt;30%)&#xD;
&#xD;
          -  Chronic kidney disease who had Cr level of greater than 2.0 mg/dl&#xD;
&#xD;
          -  Patients whose expected survival is less than 12 months&#xD;
&#xD;
          -  Patients who had a severe valvular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jung-Sun Kim, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Severance Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Cardiology, Cardiovascular Hospital, Yonsei University</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>October 11, 2020</last_update_submitted>
  <last_update_submitted_qc>October 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</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>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03298282
org study id: 1-2017-0049
nct id: NCT03298282
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The coronary images of selective angiography and optical coherence tomography with
      FFR(Fractional Flow Reserve) values of the intermediate lesions (40-70% stenosis) will be
      prospectively registered.
The patients with intermediate lesions after CT angiography and invasive coronary angiography
      will be screened, and optical coherence tomography, FFR and selective CT angiography will be
      performed. The coronary images and FFR values will be registered, and the patients will be
      followed-up up to 2 years to investigate the adverse clinical events.
observational model: Cohort
time perspective: Prospective
measure: Change of plaque on coronary CTA for during 2 years
time frame: at registration
measure: Change of plaque on coronary CTA for during 2 years
time frame: at 2-year follow up
measure: Change of plaque on coronary OCT for during 2 years
time frame: at registration
measure: Change of plaque on coronary OCT for during 2 years
time frame: at 2-year follow up
measure: Change of FFR value during 2 years
time frame: at registration
measure: Change of FFR value during 2 years
time frame: at 2-year follow up
measure: Comparison of computational FFR derived from OCT to invasive FFR
time frame: at registration
measure: Comparison of computational FFR derived from OCT to invasive FFR
time frame: at 2-year follow up
measure: Adverse event for 2 years (myocardial infarction, cardiovascular death)
time frame: within 2 years after registration
measure: Power of plaque characteristics on coronary CTA for predicting adverse events
time frame: within 2 years after registration
measure: Power of plaque characteristics on OCT for predicting adverse events
time frame: within 2 years after registration
arm group label: Imaging Registry
description: Imaging cohort: Patients with intermediate lesions
intervention type: Other
intervention name: OCT (Optical Coherence Tomography)
description: Coronary images by OCT and selective CTA and FFR values will be registered.
arm group label: Imaging Registry
intervention type: Other
intervention name: Coronary CTA
description: Coronary images by OCT and Coronary CTA and FFR values will be registered.
arm group label: Imaging Registry
intervention type: Other
intervention name: FFR
description: Coronary images by OCT and selective CTA and FFR values will be registered.
arm group label: Imaging Registry
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jung-Sun Kim, PhD
role: Principal Investigator
affiliation: Severance Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Coronary Artery Disease
sharing ipd: No