<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/NCT03030495</url>
  </required_header>
  <id_info>
    <org_study_id>IMPACT16453143</org_study_id>
    <nct_id>NCT03030495</nct_id>
  </id_info>
  <brief_title>Registry of Comprehensive Imaging and Physiological Evaluation of Deferred Lesions Based on FFR</brief_title>
  <acronym>IMPACT-FFR</acronym>
  <official_title>IMaging and Physiologic Predictors of Atherosclerotic Progression in Deferred Lesions With Contemporary Medical Treatment Based on Fractional Flow Reserve-guided Strategy</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 Ilsan Paik Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ulsan University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Keimyung University Dongsan Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. To compare the risk of atherosclerotic lesion progression and subsequent&#xD;
           patient-oriented composite outcomes (all-cause mortality, any MI, or any Ischemia-driven&#xD;
           repeat revascularization) between deferred lesions with or without over microvascular&#xD;
           disease, defined as physiological classification&#xD;
&#xD;
        2. To explore independent predictors of atherosclerotic lesion progression in deferred&#xD;
           lesions based on fractional flow reserve-guided strategy and treated by contemporary&#xD;
           medical treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The coronary artery system has 3 components with different functions: conductive epicardial&#xD;
      coronary arteries, arterioles, and capillaries. When any one of these systems fails,&#xD;
      myocardial ischemia can occur. Therefore, the presence of epicardial coronary artery stenosis&#xD;
      is not necessarily a prerequisite for ischemic heart disease (IHD). Although it has not been&#xD;
      established that microvascular disease is independent of macrovascular disease, clinical&#xD;
      studies have consistently shown that the presence of microvascular disease is an independent&#xD;
      predictor of poor clinical outcomes, especially in patients with acute myocardial infarction&#xD;
      (MI).&#xD;
&#xD;
      The pressure-derived fractional flow reserve (FFR) index has become a standard invasive&#xD;
      method to evaluate the functional significance of epicardial coronary artery stenosis, and&#xD;
      clinical outcomes of FFR-guided percutaneous coronary intervention (PCI) have proven to be&#xD;
      better than those of angiography-guided PCI or medical treatment. Although FFR-guided PCI has&#xD;
      been reported to improve patient outcomes and FFR is now regarded as the gold-standard&#xD;
      invasive method to assess the functional significance of coronary artery stenosis, there is&#xD;
      still room for further improvement in the diagnosis and treatment of patients with high FFR.&#xD;
      In the FAME II study, 14.6% of the registry arm (FFR &gt; 0.80 and deferral of PCI) experienced&#xD;
      persistent angina, and 9.0% of these patients had clinical events during a 2-year follow-up&#xD;
      period.&#xD;
&#xD;
      Therefore, microvascular assessment using coronary flow reserve (CFR) and the index of&#xD;
      microcirculatory resistance (IMR) can provide additional diagnostic and prognostic insights&#xD;
      for IHD patients, especially in those with high FFR.&#xD;
&#xD;
      Recently, Lee et al. (JACC 2016) investigated clinical outcomes among patients with high-FFR&#xD;
      and deferred revascularization, according to physiologic classification using CFR and IMR.&#xD;
      Lee et al. firstly presented that 7.0% of patients with high FFR had high IMR and low CFR and&#xD;
      were regarded as having overt microvascular disease. Although the proportion of patients with&#xD;
      high FFR who had overt microvascular disease was small, Group D had the poorest clinical&#xD;
      outcomes during follow-up. The presence of overt microvascular disease was an independent&#xD;
      prognostic factor in patients with high FFR. In addition, the presence of overt microvascular&#xD;
      disease had additive prognostic value aside from clinical risk factors, with significantly&#xD;
      improved discriminant function of the prediction model. These results suggest that the&#xD;
      invasive physiologic assessment for microvascular disease combined with CFR and IMR can help&#xD;
      identify patients at high risk for future cardiovascular events among those with high FFR.&#xD;
&#xD;
      Previous studies have shown that the presence of microvascular disease is associated with a&#xD;
      higher risk of cardiovascular events such as cardiac death, MI, or revascularization in&#xD;
      patients without flow-limiting epicardial stenosis. Several mechanisms have been proposed for&#xD;
      the association of microvascular disease and poor clinical outcomes. In addition to&#xD;
      myocardial ischemia, microvascular disease is reported to be associated with endothelial&#xD;
      dysfunction and inflammatory activity that precedes intimal thickening, lipid deposition in&#xD;
      the macrovascular system, and coronary vasomotor dysfunction. In a study by Dhawan et al.,&#xD;
      coronary microvascular dysfunction in patients with non-obstructive coronary artery disease&#xD;
      was associated with higher serum high-sensitivity C-reactive protein and a higher frequency&#xD;
      of thin-cap fibroatheroma.&#xD;
&#xD;
      In the Lee et al.'s study, the higher clinical event rates in patients with overt&#xD;
      microvascular disease resulted from cardiac death and revascularization rates higher than&#xD;
      those of the other groups. These results imply that the presence of overt microvascular&#xD;
      disease can induce accentuated atherosclerotic progression and subsequent clinical events&#xD;
      including cardiac death and ischemia-driven repeat revascularization.&#xD;
&#xD;
      Therefore, the IMaging and Physiologic Predictors of Atherosclerotic Progression in Deferred&#xD;
      Lesions with Contemporary Medical Treatment based on Fractional Flow Reserve-guided Strategy&#xD;
      (IMPACT-FFR registry) was designed to compare the risk of atherosclerotic plaque progression&#xD;
      and subsequent clinical events between deferred lesions with or without over microvascular&#xD;
      disease, defined as physiological classification and also to explore independent predictors&#xD;
      of atherosclerotic lesion progression in deferred lesions based on fractional flow&#xD;
      reserve-guided strategy and treated by contemporary medical treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>patient-oriented composite outcome</measure>
    <time_frame>24 months</time_frame>
    <description>a composite of all-cause death, MI, any repeat revascularization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>patient-oriented composite outcome</measure>
    <time_frame>12 months</time_frame>
    <description>a composite of all-cause death, MI, any repeat revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient-oriented composite outcome</measure>
    <time_frame>60 months</time_frame>
    <description>a composite of all-cause death, MI, any repeat revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause death</measure>
    <time_frame>24 months</time_frame>
    <description>All-cause death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac death</measure>
    <time_frame>24 months</time_frame>
    <description>cardiac death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target-vessel nonfatal MI</measure>
    <time_frame>24 months</time_frame>
    <description>Target-vessel nonfatal MI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-target vessel nonfatal MI</measure>
    <time_frame>24 months</time_frame>
    <description>Non-target vessel nonfatal MI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause nonfatal MI</measure>
    <time_frame>24 months</time_frame>
    <description>All-cause nonfatal MI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seattle Angina Questionnaires</measure>
    <time_frame>24 months</time_frame>
    <description>Angina severity measured with Seattle Angina Questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in normalized total atheroma volume</measure>
    <time_frame>12 months</time_frame>
    <description>TAVnormalized = [Σ (EEM CSA - lumen CSA) / no. of images in pullback images in cohort] X median no. of images in cohort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total atheroma volume index</measure>
    <time_frame>12 months</time_frame>
    <description>Indexed total atheroma volume (TAVi): Σ(EEM CSA -lumen CSA)/plaque length</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fibrous cap thickness by OCT</measure>
    <time_frame>12 months</time_frame>
    <description>Change in fibrous cap thickness by OCT at 12-month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Plaque burden at minimum lumen area site</measure>
    <time_frame>12 months</time_frame>
    <description>Change in Plaque burden at minimum lumen area site at 12-month Plaque burden = (EEM-MLA)/EEM x 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fractional flow reserve</measure>
    <time_frame>12 months</time_frame>
    <description>Change in Fractional flow reserve at 12-month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in coronary flow reserve</measure>
    <time_frame>12 months</time_frame>
    <description>Change in coronary flow reserve at 12-month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in index of microcirculatory resistance</measure>
    <time_frame>12 months</time_frame>
    <description>Change in index of microcirculatory resistance at 12-month</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1400</enrollment>
  <condition>Ischemic Heart Disease</condition>
  <arm_group>
    <arm_group_label>Overt microvascular disease</arm_group_label>
    <description>Fractional flow reserve&gt;0.80, coronary flow reserve&lt;2 &amp; Index of microvascular resistance&gt;25U</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Overt microvascular disease</arm_group_label>
    <description>Fractional flow reserve&gt;0.80, coronary flow reserve&gt;2 &amp; Index of microvascular resistance&lt;25U</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Comprehensive physiologic evaluation</intervention_name>
    <description>Comprehensive physiologic evaluation using pressure-temperature sensor wire to measure fractional flow reserve, coronary flow reserve, index of microcirculatory resistance</description>
    <arm_group_label>No Overt microvascular disease</arm_group_label>
    <arm_group_label>Overt microvascular disease</arm_group_label>
    <other_name>Comprehensive physiologic evaluation using pressure-temperature sensor wire</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intravascular imaging devices</intervention_name>
    <description>Intravascular ultrasound or optical coherence tomography</description>
    <arm_group_label>No Overt microvascular disease</arm_group_label>
    <arm_group_label>Overt microvascular disease</arm_group_label>
    <other_name>Intravascular ultrasound or optical coherence tomography</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with intermediate degree of stenosis (30-70% stenosis by visual estimation) with&#xD;
        fractional flow reserve of &gt;0.80 in major epicardial coronary artery amenable to stent&#xD;
        implantation or vessel size ≥2.5 mm.&#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 stenosis (30-70% stenosis by visual estimation)&#xD;
             with fractional flow reserve of &gt;0.80 in major epicardial coronary artery amenable to&#xD;
             stent implantation or vessel size≥2.5 mm&#xD;
&#xD;
          -  Patients whose coronary stenosis were evaluated by invasive imaging techniques&#xD;
             (intravascular ultrasound and optical coherence tomography) and physiologic assessment&#xD;
             (coronary flow reserve, index of microcirculatory resistance, and fractional flow&#xD;
             reserve)&#xD;
&#xD;
          -  Subject is able to verbally confirm understandings of risks, benefits and treatment&#xD;
             alternatives of receiving invasive physiologic or imaging evaluation and he/she or&#xD;
             his/her legally authorized representative provides written informed consent to any&#xD;
             study related procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  End-staged renal disease on peritoneal dialysis or hemodialysis (estimated GFR &lt;&#xD;
             15mL/min)&#xD;
&#xD;
          -  Acute hepatic injury&#xD;
&#xD;
          -  Cardiogenic shock (systolic blood pressure &lt; 90mmHg or requiring inotropics to&#xD;
             maintain blood pressure &gt; 90mmHg)&#xD;
&#xD;
          -  The patient has a known hypersensitivity or contraindication to any of the following&#xD;
             medications: statin, ezetimibe, heparin, aspirin, clopidogrel, prasugrel, ticagrelor&#xD;
&#xD;
          -  Non-cardiac co-morbid conditions are present with life expectancy &lt;2 year (per site&#xD;
             investigator's medical judgment)&#xD;
&#xD;
          -  Unable to perform invasive imaging study (intravascular ultrasound and optical&#xD;
             coherence tomography) or physiologic assessment (coronary flow reserve, index of&#xD;
             microcirculatory resistance, and fractional flow reserve)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joo-Yong Hahn, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bon-Kwon Koo, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joo-Yong Hahn, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <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>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 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</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-Yong Hahn</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Ischemic Heart Disease</keyword>
  <keyword>Stable angina</keyword>
  <keyword>Fractional flow reserve</keyword>
  <keyword>Index of Microcirculatory Resistance</keyword>
  <keyword>Coronary Flow Reserve</keyword>
  <keyword>Intravascular Imaging</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03030495
org study id: IMPACT16453143
nct id: NCT03030495
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
1. To compare the risk of atherosclerotic lesion progression and subsequent
           patient-oriented composite outcomes (all-cause mortality, any MI, or any Ischemia-driven
           repeat revascularization) between deferred lesions with or without over microvascular
           disease, defined as physiological classification

        2. To explore independent predictors of atherosclerotic lesion progression in deferred
           lesions based on fractional flow reserve-guided strategy and treated by contemporary
           medical treatment
The coronary artery system has 3 components with different functions: conductive epicardial
      coronary arteries, arterioles, and capillaries. When any one of these systems fails,
      myocardial ischemia can occur. Therefore, the presence of epicardial coronary artery stenosis
      is not necessarily a prerequisite for ischemic heart disease (IHD). Although it has not been
      established that microvascular disease is independent of macrovascular disease, clinical
      studies have consistently shown that the presence of microvascular disease is an independent
      predictor of poor clinical outcomes, especially in patients with acute myocardial infarction
      (MI).

      The pressure-derived fractional flow reserve (FFR) index has become a standard invasive
      method to evaluate the functional significance of epicardial coronary artery stenosis, and
      clinical outcomes of FFR-guided percutaneous coronary intervention (PCI) have proven to be
      better than those of angiography-guided PCI or medical treatment. Although FFR-guided PCI has
      been reported to improve patient outcomes and FFR is now regarded as the gold-standard
      invasive method to assess the functional significance of coronary artery stenosis, there is
      still room for further improvement in the diagnosis and treatment of patients with high FFR.
      In the FAME II study, 14.6% of the registry arm (FFR > 0.80 and deferral of PCI) experienced
      persistent angina, and 9.0% of these patients had clinical events during a 2-year follow-up
      period.

      Therefore, microvascular assessment using coronary flow reserve (CFR) and the index of
      microcirculatory resistance (IMR) can provide additional diagnostic and prognostic insights
      for IHD patients, especially in those with high FFR.

      Recently, Lee et al. (JACC 2016) investigated clinical outcomes among patients with high-FFR
      and deferred revascularization, according to physiologic classification using CFR and IMR.
      Lee et al. firstly presented that 7.0% of patients with high FFR had high IMR and low CFR and
      were regarded as having overt microvascular disease. Although the proportion of patients with
      high FFR who had overt microvascular disease was small, Group D had the poorest clinical
      outcomes during follow-up. The presence of overt microvascular disease was an independent
      prognostic factor in patients with high FFR. In addition, the presence of overt microvascular
      disease had additive prognostic value aside from clinical risk factors, with significantly
      improved discriminant function of the prediction model. These results suggest that the
      invasive physiologic assessment for microvascular disease combined with CFR and IMR can help
      identify patients at high risk for future cardiovascular events among those with high FFR.

      Previous studies have shown that the presence of microvascular disease is associated with a
      higher risk of cardiovascular events such as cardiac death, MI, or revascularization in
      patients without flow-limiting epicardial stenosis. Several mechanisms have been proposed for
      the association of microvascular disease and poor clinical outcomes. In addition to
      myocardial ischemia, microvascular disease is reported to be associated with endothelial
      dysfunction and inflammatory activity that precedes intimal thickening, lipid deposition in
      the macrovascular system, and coronary vasomotor dysfunction. In a study by Dhawan et al.,
      coronary microvascular dysfunction in patients with non-obstructive coronary artery disease
      was associated with higher serum high-sensitivity C-reactive protein and a higher frequency
      of thin-cap fibroatheroma.

      In the Lee et al.'s study, the higher clinical event rates in patients with overt
      microvascular disease resulted from cardiac death and revascularization rates higher than
      those of the other groups. These results imply that the presence of overt microvascular
      disease can induce accentuated atherosclerotic progression and subsequent clinical events
      including cardiac death and ischemia-driven repeat revascularization.

      Therefore, the IMaging and Physiologic Predictors of Atherosclerotic Progression in Deferred
      Lesions with Contemporary Medical Treatment based on Fractional Flow Reserve-guided Strategy
      (IMPACT-FFR registry) was designed to compare the risk of atherosclerotic plaque progression
      and subsequent clinical events between deferred lesions with or without over microvascular
      disease, defined as physiological classification and also to explore independent predictors
      of atherosclerotic lesion progression in deferred lesions based on fractional flow
      reserve-guided strategy and treated by contemporary medical treatment.
observational model: Cohort
time perspective: Prospective
measure: patient-oriented composite outcome
time frame: 24 months
description: a composite of all-cause death, MI, any repeat revascularization
measure: patient-oriented composite outcome
time frame: 12 months
description: a composite of all-cause death, MI, any repeat revascularization
measure: patient-oriented composite outcome
time frame: 60 months
description: a composite of all-cause death, MI, any repeat revascularization
measure: All-cause death
time frame: 24 months
description: All-cause death
measure: cardiac death
time frame: 24 months
description: cardiac death
measure: Target-vessel nonfatal MI
time frame: 24 months
description: Target-vessel nonfatal MI
measure: Non-target vessel nonfatal MI
time frame: 24 months
description: Non-target vessel nonfatal MI
measure: All-cause nonfatal MI
time frame: 24 months
description: All-cause nonfatal MI
measure: Seattle Angina Questionnaires
time frame: 24 months
description: Angina severity measured with Seattle Angina Questionnaires
measure: Change in normalized total atheroma volume
time frame: 12 months
description: TAVnormalized = [Σ (EEM CSA - lumen CSA) / no. of images in pullback images in cohort] X median no. of images in cohort
measure: Change in total atheroma volume index
time frame: 12 months
description: Indexed total atheroma volume (TAVi): Σ(EEM CSA -lumen CSA)/plaque length
measure: Change in fibrous cap thickness by OCT
time frame: 12 months
description: Change in fibrous cap thickness by OCT at 12-month
measure: Change in Plaque burden at minimum lumen area site
time frame: 12 months
description: Change in Plaque burden at minimum lumen area site at 12-month Plaque burden = (EEM-MLA)/EEM x 100
measure: Change in Fractional flow reserve
time frame: 12 months
description: Change in Fractional flow reserve at 12-month
measure: Change in coronary flow reserve
time frame: 12 months
description: Change in coronary flow reserve at 12-month
measure: Change in index of microcirculatory resistance
time frame: 12 months
description: Change in index of microcirculatory resistance at 12-month
arm group label: Overt microvascular disease
description: Fractional flow reserve>0.80, coronary flow reserve<2 & Index of microvascular resistance>25U
arm group label: No Overt microvascular disease
description: Fractional flow reserve>0.80, coronary flow reserve>2 & Index of microvascular resistance<25U
intervention type: Device
intervention name: Comprehensive physiologic evaluation
description: Comprehensive physiologic evaluation using pressure-temperature sensor wire to measure fractional flow reserve, coronary flow reserve, index of microcirculatory resistance
arm group label: No Overt microvascular disease
arm group label: Overt microvascular disease
other name: Comprehensive physiologic evaluation using pressure-temperature sensor wire
intervention type: Device
intervention name: Intravascular imaging devices
description: Intravascular ultrasound or optical coherence tomography
arm group label: No Overt microvascular disease
arm group label: Overt microvascular disease
other name: Intravascular ultrasound or optical coherence tomography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joo-Yong Hahn, MD, PhD
role: Study Chair
affiliation: Samsung Medical Center
last name: Bon-Kwon Koo, MD, PhD
role: Study Chair
affiliation: Seoul National University Hospital
last name: Joo-Yong Hahn, MD, PhD
role: Principal Investigator
affiliation: Samsung Medical Center
last name: Joo Myung Lee, MD, MPH, PhD
role: Principal Investigator
affiliation: Samsung Medical Center
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Joo-Yong Hahn
investigator title: Professor
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
sharing ipd: Yes
ipd description: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked