<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/NCT04426396</url>
  </required_header>
  <id_info>
    <org_study_id>2019-375</org_study_id>
    <nct_id>NCT04426396</nct_id>
  </id_info>
  <brief_title>Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography</brief_title>
  <acronym>ACCURATE-CT</acronym>
  <official_title>Coronary CT Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zhejiang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang 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>
      This is a blind evaluation, self-control, multicenter clinical trial designed to determine&#xD;
      the diagnostic performance of CT-FFR from coronary computed tomographic angiography (CCTA),&#xD;
      as compared to CCTA alone, for non-invasive diagnosis of the presence of a hemodynamically&#xD;
      significant coronary stenosis, using invasive fractional flow reserve (FFR) as the reference&#xD;
      standard.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2020</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">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>Sensitivity and specificity of CT-FFR compared to FFR</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy and AUC of CT-FFR compared to FFR</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">339</enrollment>
  <condition>Coronary Artery Disease</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>FFR</intervention_name>
    <description>FFR measured by pressure wire, CT-FFR computed by coronary CT angiography</description>
    <other_name>CT-FFR</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with stable angina or unstable angina who need selective surgery referred to&#xD;
        coronary angiography and physiological evaluation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age≥ 18 years old;&#xD;
&#xD;
          -  Subjects with clinical need and consent for coronary angiography;&#xD;
&#xD;
          -  Can provide the results of coronary CT angiography within 60 days prior to ICA or&#xD;
             agree to undergo coronary CT angiography;&#xD;
&#xD;
          -  The subjects knew about the experiment and signed the informed consent voluntarily.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had percutaneous coronary intervention (PCI);&#xD;
&#xD;
          -  Patients who had CABG;&#xD;
&#xD;
          -  Acute coronary syndrome, such as acute ST segment elevation;&#xD;
&#xD;
          -  Severe tachycardia or arrhythmia;&#xD;
&#xD;
          -  Patients with severe hepatorenal insufficiency;&#xD;
&#xD;
          -  Patients with congenital heart disease, implanted pacemaker or defibrillator,&#xD;
             artificial heart valve;&#xD;
&#xD;
          -  Failure to perform invasive FFR examination or obtain FFR value due to various&#xD;
             reasons;&#xD;
&#xD;
          -  Allergic to β - blockers, nitrates and adenosine, sick sinus syndrome, long QT&#xD;
             syndrome, severe hypotension, severe asthma, severe COPD or COPD;&#xD;
&#xD;
          -  Persistent or significant clinical instability, including acute chest pain (sudden&#xD;
             onset), cardiogenic shock, blood pressure instability (systolic blood pressure &lt;&#xD;
             90mmHg) and severe congestive heart failure (according to the heart classification of&#xD;
             the New York Heart Association, grade III or IV of cardiac function) or acute&#xD;
             pulmonary edema;&#xD;
&#xD;
          -  The CTA images of coronary artery showed that the stenosis rate was less than 30% or&#xD;
             greater than 90%, or the diameter of diseased segment was less than 2.0mm;&#xD;
&#xD;
          -  CT-FFR can not be calculated because of the quality of CTA image;&#xD;
&#xD;
          -  Known pregnant and lactating women;&#xD;
&#xD;
          -  Having participated in other clinical trials within 3 months;&#xD;
&#xD;
          -  Other situations that the researchers judged were not suitable for inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Second Affiliated Hospital, Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2023</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>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary 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/NCT04426396
org study id: 2019-375
nct id: NCT04426396
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a blind evaluation, self-control, multicenter clinical trial designed to determine
      the diagnostic performance of CT-FFR from coronary computed tomographic angiography (CCTA),
      as compared to CCTA alone, for non-invasive diagnosis of the presence of a hemodynamically
      significant coronary stenosis, using invasive fractional flow reserve (FFR) as the reference
      standard.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity and specificity of CT-FFR compared to FFR
time frame: 1 day
measure: Diagnostic accuracy and AUC of CT-FFR compared to FFR
time frame: 1 day
intervention type: Diagnostic Test
intervention name: FFR
description: FFR measured by pressure wire, CT-FFR computed by coronary CT angiography
other name: CT-FFR
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease