<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/NCT04401657</url>
  </required_header>
  <id_info>
    <org_study_id>FFR_Ischemia</org_study_id>
    <nct_id>NCT04401657</nct_id>
  </id_info>
  <brief_title>FFR and Inducible Myocardial Ischemia During Adenosine Stress Testing</brief_title>
  <official_title>Relationship Between Fractional Flow Reserve and Inducible Myocardial Ischemia During Adenosine Stress Testing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a prospective, single center study involving 150 patients with stable coronary artery&#xD;
      disease undergoing coronary angiography for chest pain evaluation. The relationship between&#xD;
      FFR values and inducible myocardial ischemia at the time of definite ischemia during&#xD;
      adenosine stress testing will be investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fractional flow reserve (FFR) is commonly used to search for ischemia-producing lesions&#xD;
      during percutaneous coronary intervention (PCI), and its assessment becomes an integral part&#xD;
      to guide PCI when objective evidences of inducible myocardial ischemia are not available. A&#xD;
      transient imbalance between oxygen supply and demand leads to the ischemic cascade, which are&#xD;
      typically accompanied by regional wall motion abnormalities or electrocardiographic changes&#xD;
      as objective evidences of inducible myocardial ischemia.&#xD;
&#xD;
      FFR is a pressure-derived surrogate of coronary flow limitation defined as the ratio of&#xD;
      distal coronary pressure to aortic pressure during maximal hyperemia. FFR has been indirectly&#xD;
      validated against noninvasive stress tests, and large outcome trials support the benefit of&#xD;
      FFR-guided PCI strategy. However, FFR is not a direct measurement of coronary flow, and&#xD;
      myocardial ischemia depends on coronary flow rather than pressure. In fact, an experimental&#xD;
      model shows that myocardial function can be maintained without evidences of myocardial&#xD;
      ischemia despite low FFR. Furthermore, FFR did not predict improvement in symptoms or&#xD;
      exercise performance after PCI, challenging the current threshold of FFR for discriminating&#xD;
      ischemia-producing lesions.&#xD;
&#xD;
      The clinical benefit of FFR-guided PCI is certainly related to relief of inducible myocardial&#xD;
      ischemia. However, there is little information to examine a direct link between FFR values&#xD;
      and documented inducible ischemia at the time of FFR measurement. Therefore, the&#xD;
      investigators investigate the relationship between FFR values and inducible myocardial&#xD;
      ischemia at the time of definite ischemia during adenosine stress testing.&#xD;
&#xD;
      A 12-lead ECG recordings, FFR, and two-dimensional echocardiographic monitoring will be&#xD;
      continued before, during and after adenosine infusion. When new regional wall motion&#xD;
      abnormalities in echocardiography develop, adenosine infusion is ended and echocardiographic&#xD;
      monitoring will be continued until left ventricular wall motion returns to normal. Apical&#xD;
      (two-chamber, four-chamber and five chamber views) and parasternal long-axis and short-axis&#xD;
      views will be recorded for offline analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 8, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Definite myocardial ischemia</measure>
    <time_frame>during adenosine stress testing</time_frame>
    <description>Echocardiographic wall motion score index score by 17-segment model or ST segment elevation/depression by 12-lead ECG during adenosine stress testing</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Coronary Artery Stenosis</condition>
  <arm_group>
    <arm_group_label>FFR Measurement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Myocardia ischemia evaluation during adenosine stress testing</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Fractional flow reserve with adenosine stress testing</intervention_name>
    <description>ECG, FFR, and two-dimensional echocardiographic monitoring will be continued before, during and after adenosine infusion.</description>
    <arm_group_label>FFR Measurement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women at least 18 years of age&#xD;
&#xD;
          -  Patients undergoing coronary angiography&#xD;
&#xD;
          -  Moderate to severe stenosis (diameter stenosis equal or more than 50 percent by visual&#xD;
             examination) in one major epicardial coronary artery&#xD;
&#xD;
          -  Normal left ventricular function without regional wall motion abnormality&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to adenosine stress test*&#xD;
&#xD;
          -  ECG abnormalities (bundle branch block, LVH with strain, pacing rhythm, WPW)&#xD;
&#xD;
          -  History of previous myocardial infarction&#xD;
&#xD;
          -  Significant multi-vessel coronary artery disease (diameter stenosis equal or more than&#xD;
             50%)&#xD;
&#xD;
          -  Hypertrophic cardiomyopathy&#xD;
&#xD;
          -  Significant valvular heart disease&#xD;
&#xD;
          -  Bronchial asthma or chronic obstructive lung disease&#xD;
&#xD;
          -  Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation&#xD;
             (ALT or AST &gt; 3 times upper limit of normal).&#xD;
&#xD;
          -  Current treatment for the active cancer&#xD;
&#xD;
          -  Expected life expectancy &lt; 1 year&#xD;
&#xD;
          -  Unwillingness or inability to comply with the procedures described in this protocol.&#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>Cheol Whan Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Do-Yoon Kang, MD</last_name>
    <phone>82-2-3010-1745</phone>
    <email>kdy1218@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cheol Whan Lee, MD, PhD</last_name>
      <email>cheolwlee@amc.seoul.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>CHEOL WHAN LEE, M.D., Ph.D</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Coronary artery disease</keyword>
  <keyword>Myocardial ischemia</keyword>
  <keyword>Fractional flow reserve</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Coronary Stenosis</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenosine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04401657
org study id: FFR_Ischemia
nct id: NCT04401657
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, single center study involving 150 patients with stable coronary artery
      disease undergoing coronary angiography for chest pain evaluation. The relationship between
      FFR values and inducible myocardial ischemia at the time of definite ischemia during
      adenosine stress testing will be investigated.
Fractional flow reserve (FFR) is commonly used to search for ischemia-producing lesions
      during percutaneous coronary intervention (PCI), and its assessment becomes an integral part
      to guide PCI when objective evidences of inducible myocardial ischemia are not available. A
      transient imbalance between oxygen supply and demand leads to the ischemic cascade, which are
      typically accompanied by regional wall motion abnormalities or electrocardiographic changes
      as objective evidences of inducible myocardial ischemia.

      FFR is a pressure-derived surrogate of coronary flow limitation defined as the ratio of
      distal coronary pressure to aortic pressure during maximal hyperemia. FFR has been indirectly
      validated against noninvasive stress tests, and large outcome trials support the benefit of
      FFR-guided PCI strategy. However, FFR is not a direct measurement of coronary flow, and
      myocardial ischemia depends on coronary flow rather than pressure. In fact, an experimental
      model shows that myocardial function can be maintained without evidences of myocardial
      ischemia despite low FFR. Furthermore, FFR did not predict improvement in symptoms or
      exercise performance after PCI, challenging the current threshold of FFR for discriminating
      ischemia-producing lesions.

      The clinical benefit of FFR-guided PCI is certainly related to relief of inducible myocardial
      ischemia. However, there is little information to examine a direct link between FFR values
      and documented inducible ischemia at the time of FFR measurement. Therefore, the
      investigators investigate the relationship between FFR values and inducible myocardial
      ischemia at the time of definite ischemia during adenosine stress testing.

      A 12-lead ECG recordings, FFR, and two-dimensional echocardiographic monitoring will be
      continued before, during and after adenosine infusion. When new regional wall motion
      abnormalities in echocardiography develop, adenosine infusion is ended and echocardiographic
      monitoring will be continued until left ventricular wall motion returns to normal. Apical
      (two-chamber, four-chamber and five chamber views) and parasternal long-axis and short-axis
      views will be recorded for offline analysis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Definite myocardial ischemia
time frame: during adenosine stress testing
description: Echocardiographic wall motion score index score by 17-segment model or ST segment elevation/depression by 12-lead ECG during adenosine stress testing
arm group label: FFR Measurement
arm group type: Experimental
description: Myocardia ischemia evaluation during adenosine stress testing
intervention type: Diagnostic Test
intervention name: Fractional flow reserve with adenosine stress testing
description: ECG, FFR, and two-dimensional echocardiographic monitoring will be continued before, during and after adenosine infusion.
arm group label: FFR Measurement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cheol Whan Lee, MD, PhD
role: Principal Investigator
affiliation: Asan Medical Center
last name: Do-Yoon Kang, MD
phone: 82-2-3010-1745
email: kdy1218@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: CHEOL WHAN LEE, M.D., Ph.D
investigator title: Professor
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
mesh term: Coronary Stenosis
mesh term: Ischemia
mesh term: Adenosine
sharing ipd: No