<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/NCT03791788</url>
  </required_header>
  <id_info>
    <org_study_id>QFR2018-11-112-002</org_study_id>
    <nct_id>NCT03791788</nct_id>
  </id_info>
  <brief_title>Multicenter Registry for Angiography-Derived Quantitative Flow Ratio</brief_title>
  <acronym>QFRRegistry</acronym>
  <official_title>Multicenter Registry for Diagnostic Accuracy of Angiography-Derived Quantitative Flow Ratio to Evaluate the Hemodynamic Significance of Coronary Artery Stenosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dongsan Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chosun University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      1. to investigate the feasibility and diagnostic performance of contrast quantitative flow&#xD;
           ratio (QFR) for identifying the functional significance of intermediate degree stenotic&#xD;
           lesions in all-comer patients with coronary artery disease (CAD) including presentation&#xD;
           of acute myocardial infarction (AMI) with non-culprit lesion.&#xD;
&#xD;
        2. to compare the changes of contrast QFR and fractional flow reserve (FFR) according to&#xD;
           severity of percent diameter stenosis (%DS)&#xD;
&#xD;
        3. to evaluate prognostic implication of contrast QFR in comparison with FFR&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite potential clinical benefits and abundant evidences of FFR-guided percutaneous&#xD;
      coronary intervention (PCI), adoption rate of FFR is still low in real world practice, most&#xD;
      likely due to use of additional resource and to concern about side effects of hyperemic&#xD;
      agent. Therefore, several tools to derive FFR non-invasively has been developed based on&#xD;
      computational fluid dynamics to overcome the limitations. One of the novel methods, the&#xD;
      contrast quantitative flow ratio (QFR) is a computation of FFR based on 3-dimensional&#xD;
      quantitative coronary angiography (QCA) combined with Thrombolysis in Myocardial Infarction&#xD;
      (TIMI) frame counts adjustment without hyperemic agent infusion.&#xD;
&#xD;
      Although diagnostic performance of contrast QFR for evaluation of functional significance,&#xD;
      using FFR as reference standard, is well validated in patients with stable ischemic heart&#xD;
      disease (SIHD), there have been lack of evidence regarding the reliability of QFR for&#xD;
      non-culprit stenosis in patients with AMI.&#xD;
&#xD;
      Therefore, the investigators sought to investigate the feasibility and diagnostic performance&#xD;
      of contrast QFR for identifying the functional significance of coronary stenosis in all-comer&#xD;
      patients with CAD. In addition, prognostic implication of contrast QFR will be also compared&#xD;
      with that of FFR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 30, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Actual">October 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy of QFR</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Diagnostic accuracy of contrast QFR to predict FFR lower than 0.8</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vessel-related composite outcome</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>a composite of cardiac death, vessel-related myocardial infarction, and vessel-related ischemia driven revascularization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of QFR</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Sensitivity of contrast QFR to predict FFR lower than 0.8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of QFR</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Specificity of contrast QFR to predict FFR lower than 0.8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between QFR and FFR</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Correlation between QFR and FFR</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pre-specified substudy of exercise duration after PCI</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>residual functional SYNTAX score calculated using post-PCI QFR will be used to define functional complete revascularization.&#xD;
Pre- and Post-PCI exercise treadmill test within 3 months window from PCI</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">524</enrollment>
  <condition>Ischemic Heart Disease</condition>
  <arm_group>
    <arm_group_label>QFR Group</arm_group_label>
    <description>Patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, NSTEMI (non ST-segment elevation myocardial infarction), or STEMI (ST-segment elevation myocardial infarction) with non-culprit stenosis who underwent FFR measurement and were able to analyze QFR.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>QFR assessment</intervention_name>
    <description>QFR measurement in order to evaluate functional significance of epicardial stenosis and to compare the response of QFR for worsening stenosis severity, FFR value as reference standard</description>
    <arm_group_label>QFR Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        320 patients with suspected ischemic heart disease including stable angina, or acute&#xD;
        coronary syndrome including unstable angina, non ST-segment elevation MI, or ST-segment&#xD;
        elevation MI with non-culprit stenosis who underwent FFR measurement and were able to&#xD;
        analyze QFR&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be ≥18 years&#xD;
&#xD;
          -  Patients suspected with ischemic heart disease&#xD;
&#xD;
          -  Patients with intermediate degree of coronary artery stenosis (40-70% stenosis by&#xD;
             visual estimation) in major epicardial coronary artery with FFR measurement&#xD;
&#xD;
          -  Patients who were able to analyze QFR&#xD;
&#xD;
          -  Subject is able to verbally confirm understandings of risks, benefits and treatment&#xD;
             alternatives of receiving invasive physiologic evaluation and he/she or his/her&#xD;
             legally authorized representative provides&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Left main (LM) or right coronary artery (RCA) ostial lesion&#xD;
&#xD;
          -  Severe overlap of stenotic segments&#xD;
&#xD;
          -  Severe tortuosity of target vessel&#xD;
&#xD;
          -  Poor angiographic image quality precluding contour detection&#xD;
&#xD;
          -  No optimal images with angles ≥ 25o&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Joo Myung Lee, MD, MPH, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Keimyung University Dongsan Medical Center</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Ilsan Paik Hospital</name>
      <address>
        <city>Goyang-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chosun University Hospital</name>
      <address>
        <city>Gwangju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Joo Myung Lee</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Stable angina</keyword>
  <keyword>Acute Myocardial Infarction</keyword>
  <keyword>Fractional Flow Reserve</keyword>
  <keyword>Quantitative Flow Ratio</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <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/NCT03791788
org study id: QFR2018-11-112-002
nct id: NCT03791788
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
1. to investigate the feasibility and diagnostic performance of contrast quantitative flow
           ratio (QFR) for identifying the functional significance of intermediate degree stenotic
           lesions in all-comer patients with coronary artery disease (CAD) including presentation
           of acute myocardial infarction (AMI) with non-culprit lesion.

        2. to compare the changes of contrast QFR and fractional flow reserve (FFR) according to
           severity of percent diameter stenosis (%DS)

        3. to evaluate prognostic implication of contrast QFR in comparison with FFR
Despite potential clinical benefits and abundant evidences of FFR-guided percutaneous
      coronary intervention (PCI), adoption rate of FFR is still low in real world practice, most
      likely due to use of additional resource and to concern about side effects of hyperemic
      agent. Therefore, several tools to derive FFR non-invasively has been developed based on
      computational fluid dynamics to overcome the limitations. One of the novel methods, the
      contrast quantitative flow ratio (QFR) is a computation of FFR based on 3-dimensional
      quantitative coronary angiography (QCA) combined with Thrombolysis in Myocardial Infarction
      (TIMI) frame counts adjustment without hyperemic agent infusion.

      Although diagnostic performance of contrast QFR for evaluation of functional significance,
      using FFR as reference standard, is well validated in patients with stable ischemic heart
      disease (SIHD), there have been lack of evidence regarding the reliability of QFR for
      non-culprit stenosis in patients with AMI.

      Therefore, the investigators sought to investigate the feasibility and diagnostic performance
      of contrast QFR for identifying the functional significance of coronary stenosis in all-comer
      patients with CAD. In addition, prognostic implication of contrast QFR will be also compared
      with that of FFR.
observational model: Case-Only
time perspective: Retrospective
measure: Diagnostic accuracy of QFR
time frame: through study completion, an average of 6 months
description: Diagnostic accuracy of contrast QFR to predict FFR lower than 0.8
measure: Vessel-related composite outcome
time frame: through study completion, an average of 2 year
description: a composite of cardiac death, vessel-related myocardial infarction, and vessel-related ischemia driven revascularization
measure: Sensitivity of QFR
time frame: through study completion, an average of 6 months
description: Sensitivity of contrast QFR to predict FFR lower than 0.8
measure: Specificity of QFR
time frame: through study completion, an average of 6 months
description: Specificity of contrast QFR to predict FFR lower than 0.8
measure: Correlation between QFR and FFR
time frame: through study completion, an average of 6 months
description: Correlation between QFR and FFR
measure: Pre-specified substudy of exercise duration after PCI
time frame: through study completion, an average of 3 months
description: residual functional SYNTAX score calculated using post-PCI QFR will be used to define functional complete revascularization.
Pre- and Post-PCI exercise treadmill test within 3 months window from PCI
arm group label: QFR Group
description: Patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, NSTEMI (non ST-segment elevation myocardial infarction), or STEMI (ST-segment elevation myocardial infarction) with non-culprit stenosis who underwent FFR measurement and were able to analyze QFR.
intervention type: Diagnostic Test
intervention name: QFR assessment
description: QFR measurement in order to evaluate functional significance of epicardial stenosis and to compare the response of QFR for worsening stenosis severity, FFR value as reference standard
arm group label: QFR Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Joo Myung Lee, MD, MPH, PhD
role: Principal Investigator
affiliation: Samsung Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Joo Myung Lee
investigator title: Assistant Professor
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease