<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/NCT02186093</url>
  </required_header>
  <id_info>
    <org_study_id>1404-057-573</org_study_id>
    <nct_id>NCT02186093</nct_id>
  </id_info>
  <brief_title>Clinical, Physiological and Prognostic Implication of Microvascular Status</brief_title>
  <official_title>Clinical, Physiological and Prognostic Implication of Index of Microcirculatory Resistance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ulsan University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Keimyung University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital San Carlos, Madrid</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Royal Prince Alfred Hospital, Sydney, Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <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>
      There are several physiologic parameters in evaluating cardiovascular disease. This study&#xD;
      will reveal which parameter is the most proper value in predicting disease severity and risk&#xD;
      factors of patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fractional Flow Reserve (FFR), index of microcirculatory resistance (IMR), and coronary flow&#xD;
      reserve (CFR) will be measured in stable angina patients before coronary intervention.&#xD;
&#xD;
      Relationship between angiographic characteristics of patients and FFR, IMR, CFR will be&#xD;
      analyzed. Comparison of risk factors and prognosis between parameters will be also analyzed.&#xD;
      This study will evaluate that which parameter is correlate with disease severity and risk&#xD;
      factors of patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 2009</start_date>
  <completion_date type="Anticipated">November 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Spearman correlation coefficient between FFR, IMR, CFR and angiographic severity</measure>
    <time_frame>during coronary angiography</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">1197</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Korea</arm_group_label>
    <description>patients in South of Korea</description>
  </arm_group>
  <arm_group>
    <arm_group_label>United Kingdom</arm_group_label>
    <description>patients in England</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spain</arm_group_label>
    <description>patients in Spain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>United State of America</arm_group_label>
    <description>patients in USA</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with stable angina&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  Patients with stable angina&#xD;
&#xD;
          -  FFR, IMR, CFR were measured before coronary intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have severe side effects or contraindication to hyperemic agents (ex.&#xD;
             adenosine)&#xD;
&#xD;
          -  Patients with hemodynamic instability&#xD;
&#xD;
          -  elevation of cardiac enzymes, evidence of acute MI, or a culprit vessel of acute&#xD;
             coronary syndrome&#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>Bon-Kwon Koo, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul national university hosptial</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>
  <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>Bon-Kwon Koo, MD, PhD</last_name>
    <phone>82-2-2072-2062</phone>
    <email>bkkoo@snu.ac.kr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Keimyung University Dongsan medical center</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Inje University Ilsan Paik Hospital</name>
      <address>
        <city>Goyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Completed</status>
  </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-Kwon Koo, MD, PhD</last_name>
      <phone>82-2-2072-2062</phone>
      <email>bkkoo@snu.ac.kr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joo Myung Lee, MD, MPH, PhD</last_name>
      <phone>82-10-8884-8439</phone>
      <email>drone80@hanmail.net</email>
    </contact>
    <investigator>
      <last_name>Joo Myung Lee, MD, MPH, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ulsan University Hospital, University of Ulsan College of Medicine</name>
      <address>
        <city>Ulsan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2009</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>November 24, 2017</last_update_submitted>
  <last_update_submitted_qc>November 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Angina, Stable</keyword>
  <keyword>Fractional Flow Reserve, Myocardial</keyword>
  <keyword>Coronary Angiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be available when requested after discussion in steering committee</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/NCT02186093
org study id: 1404-057-573
nct id: NCT02186093
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There are several physiologic parameters in evaluating cardiovascular disease. This study
      will reveal which parameter is the most proper value in predicting disease severity and risk
      factors of patients.
Fractional Flow Reserve (FFR), index of microcirculatory resistance (IMR), and coronary flow
      reserve (CFR) will be measured in stable angina patients before coronary intervention.

      Relationship between angiographic characteristics of patients and FFR, IMR, CFR will be
      analyzed. Comparison of risk factors and prognosis between parameters will be also analyzed.
      This study will evaluate that which parameter is correlate with disease severity and risk
      factors of patients.
observational model: Case-Only
time perspective: Prospective
measure: Spearman correlation coefficient between FFR, IMR, CFR and angiographic severity
time frame: during coronary angiography
arm group label: Korea
description: patients in South of Korea
arm group label: United Kingdom
description: patients in England
arm group label: Spain
description: patients in Spain
arm group label: United State of America
description: patients in USA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bon-Kwon Koo, MD, PhD
role: Principal Investigator
affiliation: Seoul national university hosptial
last name: Joo Myung Lee, MD, MPH, PhD
role: Principal Investigator
affiliation: Samsung Medical Center
last name: Joo Myung Lee, MD, MPH, PhD
phone: 82-10-8884-8439
email: drone80@hanmail.net
last name: Bon-Kwon Koo, MD, PhD
phone: 82-2-2072-2062
email: bkkoo@snu.ac.kr
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: No
ipd description: Data will be available when requested after discussion in steering committee