<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/NCT03021382</url>
  </required_header>
  <id_info>
    <org_study_id>No.160040</org_study_id>
    <nct_id>NCT03021382</nct_id>
  </id_info>
  <brief_title>Comparisons of Morphological Measurement Between Coronary Computed Tomography and Optical Coherence Tomography</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kobe University</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>HeartFlow, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Kobe University</source>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the precision of semi-automated lumen boundary&#xD;
      identification from coronary computed tomography angiography (cCTA) by current version of&#xD;
      HeartFlow software and the impact on fractional flow reserve (FFRCT) by using optical&#xD;
      coherence tomography (OCT) as reference standard.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Analysis of cCTA and OCT was conducted under blind in independent organizations.&#xD;
&#xD;
      After unblinding the cCTA and OCT case identification number, the OCT image was co-registered&#xD;
      to cCTA data.&#xD;
&#xD;
      After co-registration of cCTA and OCT lesion locations, the minimal lumen area (MLA) was&#xD;
      detected with both modalities. FFROCT was calculated using OCT-updated models in which&#xD;
      cCTA-based lumen geometry was replaced by OCT-based lumen geometry.&#xD;
&#xD;
      Lesions were grouped according to their severity of calcification (using Agatston score) and&#xD;
      minimum lumen diameter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between cCTA and OCT for MLA measurements</measure>
    <time_frame>Immediately after OCT scan</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between FFRCT and FFROCT</measure>
    <time_frame>Immediately after OCT scan</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of calcification on the agreement of MLA between OCT and cCTA measurement</measure>
    <time_frame>Immediately after OCT scan</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of calcification on the agreement of FFR between OCT and cCTA</measure>
    <time_frame>Immediately after OCT scan</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">72</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>severity of calcification</arm_group_label>
    <description>All vessels were divided into tertile groups according to the severity of coronary calcification evaluated by the Agatston score.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>minimal lumen diameter (MLD) ≥1.0 mm</arm_group_label>
    <description>All lesions were divided according to an MLD ≥1.0 mm, and &lt;1.0 mm by OCT in order to isolate the lesions which an MLD below the OCT catheter size.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>data collection, non-intervention</intervention_name>
    <arm_group_label>minimal lumen diameter (MLD) ≥1.0 mm</arm_group_label>
    <arm_group_label>severity of calcification</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        72 vessels in 57 patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients who underwent cCTA prior to coronary angiography and OCT within 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior coronary artery bypass graft (CABG) surgery&#xD;
&#xD;
          2. Contraindication to beta blocker agents or nitrates&#xD;
&#xD;
          3. Tachycardia or significant arrhythmia&#xD;
&#xD;
          4. Impaired chronic renal function (eGFR &lt;30)&#xD;
&#xD;
          5. Subjects with known anaphylactic allergy to iodinated contrast material&#xD;
&#xD;
          6. Pregnancy or unknown pregnancy status in subject of childbearing potential&#xD;
&#xD;
          7. Cases with poor OCT or CCTA image for analyzing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kobe University Graduate School of Medicine, Department of Cardiology</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>650-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kobe University</investigator_affiliation>
    <investigator_full_name>Hiromasa Otake</investigator_full_name>
    <investigator_title>Department of Internal Medicine, Kobe University Graduate School of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</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/NCT03021382
org study id: No.160040
nct id: NCT03021382
lead sponsor: 
collaborator: 
The objective of this study is to evaluate the precision of semi-automated lumen boundary
      identification from coronary computed tomography angiography (cCTA) by current version of
      HeartFlow software and the impact on fractional flow reserve (FFRCT) by using optical
      coherence tomography (OCT) as reference standard.
Analysis of cCTA and OCT was conducted under blind in independent organizations.

      After unblinding the cCTA and OCT case identification number, the OCT image was co-registered
      to cCTA data.

      After co-registration of cCTA and OCT lesion locations, the minimal lumen area (MLA) was
      detected with both modalities. FFROCT was calculated using OCT-updated models in which
      cCTA-based lumen geometry was replaced by OCT-based lumen geometry.

      Lesions were grouped according to their severity of calcification (using Agatston score) and
      minimum lumen diameter.
observational model: Cohort
time perspective: Retrospective
measure: Correlation between cCTA and OCT for MLA measurements
time frame: Immediately after OCT scan
measure: Correlation between FFRCT and FFROCT
time frame: Immediately after OCT scan
measure: Impact of calcification on the agreement of MLA between OCT and cCTA measurement
time frame: Immediately after OCT scan
measure: Impact of calcification on the agreement of FFR between OCT and cCTA
time frame: Immediately after OCT scan
arm group label: severity of calcification
description: All vessels were divided into tertile groups according to the severity of coronary calcification evaluated by the Agatston score.
arm group label: minimal lumen diameter (MLD) ≥1.0 mm
description: All lesions were divided according to an MLD ≥1.0 mm, and <1.0 mm by OCT in order to isolate the lesions which an MLD below the OCT catheter size.
intervention type: Other
intervention name: data collection, non-intervention
arm group label: minimal lumen diameter (MLD) ≥1.0 mm
arm group label: severity of calcification
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Kobe University
investigator full name: Hiromasa Otake
investigator title: Department of Internal Medicine, Kobe University Graduate School of Medicine
mesh term: Coronary Artery Disease