<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/NCT02208388</url>
  </required_header>
  <id_info>
    <org_study_id>AMCCV2014-06</org_study_id>
    <nct_id>NCT02208388</nct_id>
  </id_info>
  <brief_title>Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial</brief_title>
  <acronym>PERFUSERCT</acronym>
  <official_title>Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial: Ischemia-guided Revascularization Using Perfusion Coronary CT vs. Fractional Flow Reserve</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Young-Hak Kim, MD, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate safety and effectiveness of CTP(computed tomography&#xD;
      perfusion) guided revascularization vs FFR(Fractional flow reserve) guided revascularization&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 12, 2014</start_date>
  <completion_date type="Anticipated">March 5, 2028</completion_date>
  <primary_completion_date type="Anticipated">March 5, 2028</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite Events</measure>
    <time_frame>1 year</time_frame>
    <description>All cause death, Myocardial infarction, Diseased-related unplanned hospitalization or stroke</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All cause death</measure>
    <time_frame>5 year</time_frame>
    <description>All cause death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>5 year</time_frame>
    <description>Myocardial infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target vessel revascularization</measure>
    <time_frame>5 year</time_frame>
    <description>Target vessel revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis</measure>
    <time_frame>5 year</time_frame>
    <description>Stent thrombosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seattle Angina Questionnaire,EQ5D questionnaire</measure>
    <time_frame>5 year</time_frame>
    <description>Quality of life score assessed by the EQ-5D-5L The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.&#xD;
Higher score of EQ-5D and EQ VAS means the low quality of life. EQ-5D: the minimum and maximum values are 5 and 25 respectively. EQ VAS: the minimum and maximum values are 0 and 100 respectively.&#xD;
Seattle Angina Questionnaire The Seattle Angina Questionnaire (SAQ) is a vali- dated disease-specific instrument for assessing the health status of patients with coronary artery disease.&#xD;
SAQ scores can be aligned with clinical constructs (eg, scores on the SAQ angina frequency scale of 0-30 points indicate daily angina, 31-60 points indicate weekly angina, 61-99 points indicate monthly angina, and 100 points indicate no angina)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success of intervention</measure>
    <time_frame>5 year</time_frame>
    <description>Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost effective analysis</measure>
    <time_frame>1 year</time_frame>
    <description>Cost effective analysis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Coronary Disease</condition>
  <arm_group>
    <arm_group_label>Computed tomography perfusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with Computed tomography perfusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fractional flow reserve</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with Fractional flow reserve</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>computed tomography perfusion guided treatment</intervention_name>
    <arm_group_label>Computed tomography perfusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fractional flow reserve guided treatment</intervention_name>
    <arm_group_label>Fractional flow reserve</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 20 and more&#xD;
&#xD;
          -  Diagnosed angina or angina equivalent symptom or positive exercise treadmill test&#xD;
&#xD;
          -  Patients with intermediate- or high-risk probability of CAD defined by Diamond and&#xD;
             Forester&#xD;
&#xD;
          -  70 % stenosis or more in coronary CTA&#xD;
&#xD;
          -  Willing to provide informed, written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Requirement for surgical procedure&#xD;
&#xD;
          -  Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support&#xD;
&#xD;
          -  Recent STEMI (&lt;5 days)&#xD;
&#xD;
          -  Non STEMI, if the cardiac troponin is not stable or starting to decline&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt;30%&#xD;
&#xD;
          -  Life expectancy &lt;2 years&#xD;
&#xD;
          -  Impaired renal function with an effective glomerular filtration rate less than&#xD;
             30mL/min/1.73 ㎡ or creatinine more than 2.0 mg/dL&#xD;
&#xD;
          -  Undergoing evaluation for organ transplantation&#xD;
&#xD;
          -  Participation or planned participation in another cardiovascular clinical trial&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inability to take dual antiplatelet therapy for six months&#xD;
&#xD;
          -  Previous CABG&#xD;
&#xD;
          -  Left main disease requiring revascularization&#xD;
&#xD;
          -  Any target lesion with in-stent restenosis&#xD;
&#xD;
          -  NYHA class 3 or 4a&#xD;
&#xD;
          -  Severe and persistent angina with severe limitation in everyday living activities&#xD;
             (Canadian Cardiovascular Society grading Class IV)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Byoung-Wook Choi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Severance Hospital, Yonsei University College of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Young-Hak Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Young-Hak Kim, MD</last_name>
    <email>mdyhkim@amc.seoul.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Songpa-Gu</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Young-Hak Kim, MD, PhD</last_name>
      <phone>82-2-3010-3955</phone>
      <email>mdyhkim@amc.seoul.kr</email>
    </contact>
    <investigator>
      <last_name>Young-Hak Kim, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hallym University Sacred Heart Hospital</name>
      <address>
        <city>Anyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Gangwon National Univ. Hospital</name>
      <address>
        <city>Chuncheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <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>Pusan National University Hospital</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Enrolling by invitation</status>
  </location>
  <location>
    <facility>
      <name>Pusan National University Yangsan Hospital</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>April 4, 2023</last_update_submitted>
  <last_update_submitted_qc>April 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Young-Hak Kim, MD, PhD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Computed tomography perfusion</keyword>
  <keyword>Fractional flow reserve</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02208388
org study id: AMCCV2014-06
nct id: NCT02208388
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate safety and effectiveness of CTP(computed tomography
      perfusion) guided revascularization vs FFR(Fractional flow reserve) guided revascularization
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Composite Events
time frame: 1 year
description: All cause death, Myocardial infarction, Diseased-related unplanned hospitalization or stroke
measure: All cause death
time frame: 5 year
description: All cause death
measure: Myocardial infarction
time frame: 5 year
description: Myocardial infarction
measure: Target vessel revascularization
time frame: 5 year
description: Target vessel revascularization
measure: Stent thrombosis
time frame: 5 year
description: Stent thrombosis
measure: Seattle Angina Questionnaire,EQ5D questionnaire
time frame: 5 year
description: Quality of life score assessed by the EQ-5D-5L The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Higher score of EQ-5D and EQ VAS means the low quality of life. EQ-5D: the minimum and maximum values are 5 and 25 respectively. EQ VAS: the minimum and maximum values are 0 and 100 respectively.
Seattle Angina Questionnaire The Seattle Angina Questionnaire (SAQ) is a vali- dated disease-specific instrument for assessing the health status of patients with coronary artery disease.
SAQ scores can be aligned with clinical constructs (eg, scores on the SAQ angina frequency scale of 0-30 points indicate daily angina, 31-60 points indicate weekly angina, 61-99 points indicate monthly angina, and 100 points indicate no angina)
measure: Success of intervention
time frame: 5 year
description: Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death
measure: Cost effective analysis
time frame: 1 year
description: Cost effective analysis
arm group label: Computed tomography perfusion
arm group type: Experimental
description: Patients with Computed tomography perfusion
arm group label: Fractional flow reserve
arm group type: Active Comparator
description: Patients with Fractional flow reserve
intervention type: Device
intervention name: computed tomography perfusion guided treatment
arm group label: Computed tomography perfusion
intervention type: Device
intervention name: Fractional flow reserve guided treatment
arm group label: Fractional flow reserve
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Byoung-Wook Choi, MD
role: Principal Investigator
affiliation: Severance Hospital, Yonsei University College of Medicine
last name: Young-Hak Kim, MD
role: Principal Investigator
affiliation: Asan Medical Center
last name: Young-Hak Kim, MD
email: mdyhkim@amc.seoul.kr
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Enrolling by invitation
facility: 
status: Completed
facility: 
status: Withdrawn
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Asan Medical Center
investigator full name: Young-Hak Kim, MD, PhD
investigator title: MD
mesh term: Coronary Disease