<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/NCT03795714</url>
  </required_header>
  <id_info>
    <org_study_id>IVUS2017-11-056-001</org_study_id>
    <nct_id>NCT03795714</nct_id>
  </id_info>
  <brief_title>Association Between IVUS and OCT Parameters and Invasive Physiologic Indices</brief_title>
  <official_title>Intravascular Ultrasound and Optical Coherence Tomography-Defined Optimal Criteria and Plaque Characteristics for Defining the Functional Significance of Coronary Stenoses Using Resting and Hyperemic Physiologic Indices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</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 evaluate diagnostic accuracy and performance of IVUS and OCT-derived quantitative&#xD;
           parameters to predict functional significance of stenosis defined using all the&#xD;
           available physiologic indices.&#xD;
&#xD;
        2. to explores the association between intravascular imaging-derived plaque characteristics&#xD;
           and invasive physiologic indices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Given the inherent limitations of coronary angiography to depict the presence of functionally&#xD;
      significant epicardial coronary stenosis and discrepancy between angiographic stenosis&#xD;
      severity and the presence of myocardial ischemia, invasive physiologic indices such as&#xD;
      fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) has been a standard&#xD;
      method to guide decision of revascularization.&#xD;
&#xD;
      Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are an intracoronary&#xD;
      imaging method able to provide information about lumen area, vessel area, plaque burden, and&#xD;
      plaque characteristics that can be used for the guidance of revascularization procedure.&#xD;
      Several previous studies explored the diagnostic performance of intravascular imaging-defined&#xD;
      quantitative parameters to predict functional significance defined by FFR, however,&#xD;
      quantitative parameter derived from intravascular imaging showed only moderate diagnostic&#xD;
      accuracy and the optimal cut-off value of intravascular imaging-derived minimal lumen area&#xD;
      (MLA) or minimal lumen diameter (MLD) were varied according to the patient population,&#xD;
      interrogated vessels, and the location of target lesions, suggesting limited clinical&#xD;
      relevance of judging functional significance of target stenosis using intravascular imaging&#xD;
      alone. Nevertheless, the adoption rate of FFR-guided decision has been limited due to various&#xD;
      reasons and intravascular image-guided decision has been still used in substantial proportion&#xD;
      of the patients.&#xD;
&#xD;
      Recently, new resting pressure-derived indices including resting full-cycle ratio (RFR) or&#xD;
      diastolic pressure ratio (dPR) have been introduced as other substitutes for iFR, which does&#xD;
      not require administration of hyperemic agents, therefore, possess more convenient in daily&#xD;
      practice. Recent study with the largest sample size demonstrated identical diagnostic&#xD;
      property and prognostic implication among iFR, RFR, and dPR. As those resting&#xD;
      pressure-derived indices might have more generalizability for daily practice, it is expected&#xD;
      to raise the adoption rate of physiologic interrogation. Therefore, understanding the&#xD;
      association between all the available physiologic indices and intravascular imaging-derived&#xD;
      quantitative and qualitative parameters might be important in clinical decision for patient&#xD;
      who underwent invasive coronary angiography.&#xD;
&#xD;
      In this regard, the investigators sought to evaluate diagnostic accuracy and performance of&#xD;
      intravascular imaging-derived quantitative parameters to predict functional significance of&#xD;
      stenosis defined using all the available physiologic indices and further explores the&#xD;
      association between IVUS and OCT-derived plaque characteristics and invasive physiologic&#xD;
      indices.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 17, 2017</start_date>
  <completion_date type="Anticipated">March 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2019</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 percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by fractional flow reserve (FFR)</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by instantaneous wave-free ratio (iFR)</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by diastolic pressure ratio (dPR)</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by resting full-cycle ratio (RFR)</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance assessed by iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance defined by iFR ≤0.89</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance assessed by dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance defined by dPR ≤0.89</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear correlation between percent diameter stenosis and FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Linear regression analysis between percent diameter stenosis and FFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear correlation between percent diameter stenosis and iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Linear regression analysis between percent diameter stenosis and iFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear correlation between percent diameter stenosis and dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Linear regression analysis between percent diameter stenosis and dPR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear correlation between percent diameter stenosis and RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Linear regression analysis between percent diameter stenosis and RFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear correlation between minimal lumen diameter and FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Linear regression analysis between minimal lumen diameter and FFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear correlation between minimal lumen diameter and iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Linear regression analysis between minimal lumen diameter and iFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear correlation between minimal lumen diameter and dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Linear regression analysis between minimal lumen diameter and dPR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear correlation between minimal lumen diameter and RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Linear regression analysis between minimal lumen diameter and RFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear correlation between minimal lumen area and FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Linear regression analysis between minimal lumen area and FFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear correlation between minimal lumen area and iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Linear regression analysis between minimal lumen area and iFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear correlation between minimal lumen area and dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Linear regression analysis between minimal lumen area and dPR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear correlation between minimal lumen area and RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Linear regression analysis between minimal lumen area and RFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear correlation between plaque burden and FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Linear regression analysis between plaque burden and FFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear correlation between plaque burden and iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Linear regression analysis between plaque burden and iFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear correlation between plaque burden and dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Linear regression analysis between plaque burden and dPR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear correlation between plaque burden and RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Linear regression analysis between plaque burden and RFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminatory function of percent diameter stenosis to predict functional significance assessed by FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Discriminatory function of percent diameter stenosis to predict functional significance defined by FFR≤0.80</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminatory function of percent diameter stenosis to predict functional significance assessed by iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Discriminatory function of percent diameter stenosis to predict functional significance defined by iFR≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminatory function of percent diameter stenosis to predict functional significance assessed by dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Discriminatory function of percent diameter stenosis to predict functional significance defined by dPR≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminatory function of percent diameter stenosis to predict functional significance assessed by RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Discriminatory function of percent diameter stenosis to predict functional significance defined by RFR≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminatory function of minimal lumen diameter to predict functional significance assessed by FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Discriminatory function of minimal lumen diameter to predict functional significance defined by FFR≤0.80</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminatory function of minimal lumen diameter to predict functional significance assessed by iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Discriminatory function of minimal lumen diameter to predict functional significance defined by iFR≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminatory function of minimal lumen diameter to predict functional significance assessed by dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Discriminatory function of minimal lumen diameter to predict functional significance defined by dPR≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminatory function of minimal lumen diameter to predict functional significance assessed by RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Discriminatory function of minimal lumen diameter to predict functional significance defined by RFR≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminatory function of minimal lumen area to predict functional significance assessed by FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Discriminatory function of minimal lumen area to predict functional significance defined by FFR≤0.80</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminatory function of minimal lumen area to predict functional significance assessed by iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Discriminatory function of minimal lumen area to predict functional significance defined by iFR≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminatory function of minimal lumen area to predict functional significance assessed by dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Discriminatory function of minimal lumen area to predict functional significance defined by dPR≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminatory function of minimal lumen area to predict functional significance assessed by RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Discriminatory function of minimal lumen area to predict functional significance defined by RFR≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminatory function of plaque burden to predict functional significance assessed by FFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Discriminatory function of plaque burden to predict functional significance defined by FFR≤0.80</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminatory function of plaque burden to predict functional significance assessed by iFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Discriminatory function of plaque burden to predict functional significance defined by iFR≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminatory function of plaque burden to predict functional significance assessed by dPR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Discriminatory function of plaque burden to predict functional significance defined by dPR≤0.89</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminatory function of plaque burden to predict functional significance assessed by RFR</measure>
    <time_frame>During Cardiac Cath</time_frame>
    <description>Discriminatory function of plaque burden to predict functional significance defined by RFR≤0.89</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">166</enrollment>
  <condition>Ischemic Heart Disease</condition>
  <arm_group>
    <arm_group_label>Intravascular Imaging and Physiologic Assessment</arm_group_label>
    <description>330 patients with suspected ischemic heart disease and who underwent IVUS or OCT assessment and invasive physiologic assessment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>IVUS or OCT and Invasive physiologic indices</intervention_name>
    <description>IVUS or OCT measurement in order to evaluate the lesion morphology and stent optimization, and invasive physiologic measurement in order to functional significance of epicardial stenosis</description>
    <arm_group_label>Intravascular Imaging and Physiologic Assessment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        330 patients with suspected ischemic heart disease and who underwent IVUS or OCT assessment&#xD;
        and invasive physiologic assessment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who suspected ischemic heart disease, and underwent invasive physiologic&#xD;
             assessment and intravascular ultrasound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiogenic shock&#xD;
&#xD;
          -  Graft vessel&#xD;
&#xD;
          -  In-stent restenosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bon-Kwon Koo, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joo Myung Lee, MD, MPH, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joo Myung Lee, MD, MPH, PhD</last_name>
    <phone>82-10-8884-8439</phone>
    <email>drone80@hanmail.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ki Hong Choi, MD</last_name>
    <phone>82-10-8875-1648</phone>
    <email>cardiokh@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joo Myung Lee, MD, MPH, PhD</last_name>
      <email>drone80@hanmail.net</email>
    </contact>
    <contact_backup>
      <last_name>Ki Hong Choi, MD</last_name>
      <email>cardiokh@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Joo Myung Lee, MD, MPH, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ki Hong Choi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Seoul national university hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bon-kown Koo, MD/PhD</last_name>
      <phone>82-2-2072-2062</phone>
      <email>bkkoo@snu.ac.kr</email>
    </contact>
    <investigator>
      <last_name>Bon-kwon Koo, MD/PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Bon-Kwon Koo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Intravascular Ultrasound</keyword>
  <keyword>Optical Coherence Tomography</keyword>
  <keyword>Fractional Flow Reserve</keyword>
  <keyword>Diastolic Pressure Ratio</keyword>
  <keyword>Resting Full-Cycle Ratio</keyword>
  <keyword>Ischemic Heart Disease</keyword>
  <keyword>Instantaneous Wave-free 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/NCT03795714
org study id: IVUS2017-11-056-001
nct id: NCT03795714
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
1. to evaluate diagnostic accuracy and performance of IVUS and OCT-derived quantitative
           parameters to predict functional significance of stenosis defined using all the
           available physiologic indices.

        2. to explores the association between intravascular imaging-derived plaque characteristics
           and invasive physiologic indices.
Given the inherent limitations of coronary angiography to depict the presence of functionally
      significant epicardial coronary stenosis and discrepancy between angiographic stenosis
      severity and the presence of myocardial ischemia, invasive physiologic indices such as
      fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) has been a standard
      method to guide decision of revascularization.

      Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are an intracoronary
      imaging method able to provide information about lumen area, vessel area, plaque burden, and
      plaque characteristics that can be used for the guidance of revascularization procedure.
      Several previous studies explored the diagnostic performance of intravascular imaging-defined
      quantitative parameters to predict functional significance defined by FFR, however,
      quantitative parameter derived from intravascular imaging showed only moderate diagnostic
      accuracy and the optimal cut-off value of intravascular imaging-derived minimal lumen area
      (MLA) or minimal lumen diameter (MLD) were varied according to the patient population,
      interrogated vessels, and the location of target lesions, suggesting limited clinical
      relevance of judging functional significance of target stenosis using intravascular imaging
      alone. Nevertheless, the adoption rate of FFR-guided decision has been limited due to various
      reasons and intravascular image-guided decision has been still used in substantial proportion
      of the patients.

      Recently, new resting pressure-derived indices including resting full-cycle ratio (RFR) or
      diastolic pressure ratio (dPR) have been introduced as other substitutes for iFR, which does
      not require administration of hyperemic agents, therefore, possess more convenient in daily
      practice. Recent study with the largest sample size demonstrated identical diagnostic
      property and prognostic implication among iFR, RFR, and dPR. As those resting
      pressure-derived indices might have more generalizability for daily practice, it is expected
      to raise the adoption rate of physiologic interrogation. Therefore, understanding the
      association between all the available physiologic indices and intravascular imaging-derived
      quantitative and qualitative parameters might be important in clinical decision for patient
      who underwent invasive coronary angiography.

      In this regard, the investigators sought to evaluate diagnostic accuracy and performance of
      intravascular imaging-derived quantitative parameters to predict functional significance of
      stenosis defined using all the available physiologic indices and further explores the
      association between IVUS and OCT-derived plaque characteristics and invasive physiologic
      indices.
observational model: Case-Only
time perspective: Retrospective
measure: Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by fractional flow reserve (FFR)
time frame: During Cardiac Cath
description: Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80
measure: Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by instantaneous wave-free ratio (iFR)
time frame: During Cardiac Cath
description: Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89
measure: Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by diastolic pressure ratio (dPR)
time frame: During Cardiac Cath
description: Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89
measure: Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by resting full-cycle ratio (RFR)
time frame: During Cardiac Cath
description: Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89
measure: Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR
time frame: During Cardiac Cath
description: Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80
measure: Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR
time frame: During Cardiac Cath
description: Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89
measure: Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR
time frame: During Cardiac Cath
description: Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89
measure: Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR
time frame: During Cardiac Cath
description: Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89
measure: Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR
time frame: During Cardiac Cath
description: Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80
measure: Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR
time frame: During Cardiac Cath
description: Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89
measure: Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR
time frame: During Cardiac Cath
description: Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89
measure: Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR
time frame: During Cardiac Cath
description: Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89
measure: Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR
time frame: During Cardiac Cath
description: Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80
measure: Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance assessed by iFR
time frame: During Cardiac Cath
description: Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance defined by iFR ≤0.89
measure: Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance assessed by dPR
time frame: During Cardiac Cath
description: Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance defined by dPR ≤0.89
measure: Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR
time frame: During Cardiac Cath
description: Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89
measure: Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by FFR
time frame: During Cardiac Cath
description: Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80
measure: Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by iFR
time frame: During Cardiac Cath
description: Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89
measure: Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by dPR
time frame: During Cardiac Cath
description: Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89
measure: Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by RFR
time frame: During Cardiac Cath
description: Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89
measure: Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR
time frame: During Cardiac Cath
description: Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80
measure: Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR
time frame: During Cardiac Cath
description: Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89
measure: Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR
time frame: During Cardiac Cath
description: Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89
measure: Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR
time frame: During Cardiac Cath
description: Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89
measure: Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR
time frame: During Cardiac Cath
description: Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80
measure: Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR
time frame: During Cardiac Cath
description: Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89
measure: Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR
time frame: During Cardiac Cath
description: Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89
measure: Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR
time frame: During Cardiac Cath
description: Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89
measure: Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR
time frame: During Cardiac Cath
description: Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80
measure: Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by iFR
time frame: During Cardiac Cath
description: Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89
measure: Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by dPR
time frame: During Cardiac Cath
description: Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89
measure: Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR
time frame: During Cardiac Cath
description: Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89
measure: Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by FFR
time frame: During Cardiac Cath
description: Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80
measure: Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by iFR
time frame: During Cardiac Cath
description: Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89
measure: Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by dPR
time frame: During Cardiac Cath
description: Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89
measure: Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by RFR
time frame: During Cardiac Cath
description: Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89
measure: Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR
time frame: During Cardiac Cath
description: Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80
measure: Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR
time frame: During Cardiac Cath
description: Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89
measure: Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR
time frame: During Cardiac Cath
description: Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89
measure: Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR
time frame: During Cardiac Cath
description: Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89
measure: Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR
time frame: During Cardiac Cath
description: Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80
measure: Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR
time frame: During Cardiac Cath
description: Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89
measure: Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR
time frame: During Cardiac Cath
description: Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89
measure: Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR
time frame: During Cardiac Cath
description: Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89
measure: Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR
time frame: During Cardiac Cath
description: Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80
measure: Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by iFR
time frame: During Cardiac Cath
description: Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89
measure: Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by dPR
time frame: During Cardiac Cath
description: Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89
measure: Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR
time frame: During Cardiac Cath
description: Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89
measure: Linear correlation between percent diameter stenosis and FFR
time frame: During Cardiac Cath
description: Linear regression analysis between percent diameter stenosis and FFR
measure: Linear correlation between percent diameter stenosis and iFR
time frame: During Cardiac Cath
description: Linear regression analysis between percent diameter stenosis and iFR
measure: Linear correlation between percent diameter stenosis and dPR
time frame: During Cardiac Cath
description: Linear regression analysis between percent diameter stenosis and dPR
measure: Linear correlation between percent diameter stenosis and RFR
time frame: During Cardiac Cath
description: Linear regression analysis between percent diameter stenosis and RFR
measure: Linear correlation between minimal lumen diameter and FFR
time frame: During Cardiac Cath
description: Linear regression analysis between minimal lumen diameter and FFR
measure: Linear correlation between minimal lumen diameter and iFR
time frame: During Cardiac Cath
description: Linear regression analysis between minimal lumen diameter and iFR
measure: Linear correlation between minimal lumen diameter and dPR
time frame: During Cardiac Cath
description: Linear regression analysis between minimal lumen diameter and dPR
measure: Linear correlation between minimal lumen diameter and RFR
time frame: During Cardiac Cath
description: Linear regression analysis between minimal lumen diameter and RFR
measure: Linear correlation between minimal lumen area and FFR
time frame: During Cardiac Cath
description: Linear regression analysis between minimal lumen area and FFR
measure: Linear correlation between minimal lumen area and iFR
time frame: During Cardiac Cath
description: Linear regression analysis between minimal lumen area and iFR
measure: Linear correlation between minimal lumen area and dPR
time frame: During Cardiac Cath
description: Linear regression analysis between minimal lumen area and dPR
measure: Linear correlation between minimal lumen area and RFR
time frame: During Cardiac Cath
description: Linear regression analysis between minimal lumen area and RFR
measure: Linear correlation between plaque burden and FFR
time frame: During Cardiac Cath
description: Linear regression analysis between plaque burden and FFR
measure: Linear correlation between plaque burden and iFR
time frame: During Cardiac Cath
description: Linear regression analysis between plaque burden and iFR
measure: Linear correlation between plaque burden and dPR
time frame: During Cardiac Cath
description: Linear regression analysis between plaque burden and dPR
measure: Linear correlation between plaque burden and RFR
time frame: During Cardiac Cath
description: Linear regression analysis between plaque burden and RFR
measure: Discriminatory function of percent diameter stenosis to predict functional significance assessed by FFR
time frame: During Cardiac Cath
description: Discriminatory function of percent diameter stenosis to predict functional significance defined by FFR≤0.80
measure: Discriminatory function of percent diameter stenosis to predict functional significance assessed by iFR
time frame: During Cardiac Cath
description: Discriminatory function of percent diameter stenosis to predict functional significance defined by iFR≤0.89
measure: Discriminatory function of percent diameter stenosis to predict functional significance assessed by dPR
time frame: During Cardiac Cath
description: Discriminatory function of percent diameter stenosis to predict functional significance defined by dPR≤0.89
measure: Discriminatory function of percent diameter stenosis to predict functional significance assessed by RFR
time frame: During Cardiac Cath
description: Discriminatory function of percent diameter stenosis to predict functional significance defined by RFR≤0.89
measure: Discriminatory function of minimal lumen diameter to predict functional significance assessed by FFR
time frame: During Cardiac Cath
description: Discriminatory function of minimal lumen diameter to predict functional significance defined by FFR≤0.80
measure: Discriminatory function of minimal lumen diameter to predict functional significance assessed by iFR
time frame: During Cardiac Cath
description: Discriminatory function of minimal lumen diameter to predict functional significance defined by iFR≤0.89
measure: Discriminatory function of minimal lumen diameter to predict functional significance assessed by dPR
time frame: During Cardiac Cath
description: Discriminatory function of minimal lumen diameter to predict functional significance defined by dPR≤0.89
measure: Discriminatory function of minimal lumen diameter to predict functional significance assessed by RFR
time frame: During Cardiac Cath
description: Discriminatory function of minimal lumen diameter to predict functional significance defined by RFR≤0.89
measure: Discriminatory function of minimal lumen area to predict functional significance assessed by FFR
time frame: During Cardiac Cath
description: Discriminatory function of minimal lumen area to predict functional significance defined by FFR≤0.80
measure: Discriminatory function of minimal lumen area to predict functional significance assessed by iFR
time frame: During Cardiac Cath
description: Discriminatory function of minimal lumen area to predict functional significance defined by iFR≤0.89
measure: Discriminatory function of minimal lumen area to predict functional significance assessed by dPR
time frame: During Cardiac Cath
description: Discriminatory function of minimal lumen area to predict functional significance defined by dPR≤0.89
measure: Discriminatory function of minimal lumen area to predict functional significance assessed by RFR
time frame: During Cardiac Cath
description: Discriminatory function of minimal lumen area to predict functional significance defined by RFR≤0.89
measure: Discriminatory function of plaque burden to predict functional significance assessed by FFR
time frame: During Cardiac Cath
description: Discriminatory function of plaque burden to predict functional significance defined by FFR≤0.80
measure: Discriminatory function of plaque burden to predict functional significance assessed by iFR
time frame: During Cardiac Cath
description: Discriminatory function of plaque burden to predict functional significance defined by iFR≤0.89
measure: Discriminatory function of plaque burden to predict functional significance assessed by dPR
time frame: During Cardiac Cath
description: Discriminatory function of plaque burden to predict functional significance defined by dPR≤0.89
measure: Discriminatory function of plaque burden to predict functional significance assessed by RFR
time frame: During Cardiac Cath
description: Discriminatory function of plaque burden to predict functional significance defined by RFR≤0.89
arm group label: Intravascular Imaging and Physiologic Assessment
description: 330 patients with suspected ischemic heart disease and who underwent IVUS or OCT assessment and invasive physiologic assessment.
intervention type: Diagnostic Test
intervention name: IVUS or OCT and Invasive physiologic indices
description: IVUS or OCT measurement in order to evaluate the lesion morphology and stent optimization, and invasive physiologic measurement in order to functional significance of epicardial stenosis
arm group label: Intravascular Imaging and Physiologic Assessment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bon-Kwon Koo, MD, PhD
role: Study Chair
affiliation: Professor
last name: Joo Myung Lee, MD, MPH, PhD
role: Principal Investigator
affiliation: Assistant Professor
last name: Joo Myung Lee, MD, MPH, PhD
phone: 82-10-8884-8439
email: drone80@hanmail.net
last name: Ki Hong Choi, MD
phone: 82-10-8875-1648
email: cardiokh@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Bon-Kwon Koo
investigator title: Professor
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease