<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/NCT04485234</url>
  </required_header>
  <id_info>
    <org_study_id>ILIAS Registry</org_study_id>
    <nct_id>NCT04485234</nct_id>
  </id_info>
  <brief_title>Inclusive Invasive Physiological Assessment in Angina Syndromes Registry</brief_title>
  <acronym>ILIAS Registry</acronym>
  <official_title>Inclusive Invasive Physiological Assessment in Angina Syndromes Registry (ILIAS Registry)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amsterdam UMC, location VUmc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tergooi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Amphia Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Keimyung University Dongsan Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ulsan University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tsuchiura Kyodo General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital San Carlos, Madrid</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Catholic University of the Sacred Heart</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gifu Heart Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Toda Central General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</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 study evaluates the prognostic value and potential therapeutic impact of combined&#xD;
      pressure and flow measurements in the evaluation of epicardial coronary stenosis and&#xD;
      microvascular function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ILIAS registry is a global effort to gather lesion-level data on the diagnostic and&#xD;
      prognostic value of combined coronary pressure and flow measurements in clinical practice.&#xD;
      Data is gathered from 7 nations (The Netherlands, Korea, Japan, Spain, Italy, Denmark, USA),&#xD;
      using either coronary Doppler velocity measurements or coronary thermodilution measurements&#xD;
      to obtain invasive coronary flow assessment. Patient treatment was governed by the local&#xD;
      clinical practice guidelines at the time of the invasive procedure, but was at the operator's&#xD;
      discretion. A standardized data collection sheet was used and all study adopted standardized&#xD;
      definition of patient's baseline characteristics, clinical outcomes, and physiologic data. In&#xD;
      case of acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial&#xD;
      infarction, and ST-segment elevation myocardial infarction), only non-culprit vessel&#xD;
      evaluation was used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Actual">March 25, 2021</completion_date>
  <primary_completion_date type="Actual">March 25, 2021</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>Major adverse cardiac events</measure>
    <time_frame>10 years</time_frame>
    <description>Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Target vessel failure</measure>
    <time_frame>10 years</time_frame>
    <description>Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individual components of MACE and TVF</measure>
    <time_frame>10 years</time_frame>
    <description>Cumulative incidence of the individual components of MACE and TVF</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2322</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Microvascular Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>All patients</arm_group_label>
    <description>All lesions undergo assessment with coronary pressure sensor and either Doppler velocity or coronary thermodilution</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Coronary Flow Reserve, Microvascular resistance</intervention_name>
    <description>Calculation of the resting mean distal coronary to aortic pressure ratio (resting Pd/Pa), fractional flow reserve (Pd/Pa at hyperemia), Coronary flow reserve (peak flow/resting flow), microvascular resistance (Pd/flow).</description>
    <arm_group_label>All patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing clinically indicated invasive coronary angiography and with an&#xD;
        indication for invasive physiological evaluation of at least 1 native coronary artery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  underwent combined measurements of coronary pressure and flow for at least 1native&#xD;
             coronary artery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hemodynamic instability&#xD;
&#xD;
          -  culprit vessel of acute 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>
  <location>
    <facility>
      <name>Cincinnati University Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catholic University of the Sacred Heart</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gifu Heart Center</name>
      <address>
        <city>Gifu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toda Central General Hospital</name>
      <address>
        <city>Toda</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tsuchiura Kyodo General Hospital</name>
      <address>
        <city>Tsuchiura</city>
        <country>Japan</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>
    <facility>
      <name>Amsterdam UMC - location AMC</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tergooi</name>
      <address>
        <city>Blaricum</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amphia Hospital</name>
      <address>
        <city>Breda</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>March 25, 2021</last_update_submitted>
  <last_update_submitted_qc>March 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Tim van de Hoef</investigator_full_name>
    <investigator_title>M.D., Ph.D.</investigator_title>
  </responsible_party>
  <keyword>Coronary flow reserve</keyword>
  <keyword>Fractional flow reserve</keyword>
  <keyword>Microvascular resistance</keyword>
  <keyword>Thermodilution</keyword>
  <keyword>Doppler flow velocity</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>Anonymized patient level data will be made available by the corresponding author for reasonable requests. Consent was not obtained for data sharing but the presented data are fully anonymized and risk of identification is negligible.</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/NCT04485234
org study id: ILIAS Registry
nct id: NCT04485234
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
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has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the prognostic value and potential therapeutic impact of combined
      pressure and flow measurements in the evaluation of epicardial coronary stenosis and
      microvascular function.
ILIAS registry is a global effort to gather lesion-level data on the diagnostic and
      prognostic value of combined coronary pressure and flow measurements in clinical practice.
      Data is gathered from 7 nations (The Netherlands, Korea, Japan, Spain, Italy, Denmark, USA),
      using either coronary Doppler velocity measurements or coronary thermodilution measurements
      to obtain invasive coronary flow assessment. Patient treatment was governed by the local
      clinical practice guidelines at the time of the invasive procedure, but was at the operator's
      discretion. A standardized data collection sheet was used and all study adopted standardized
      definition of patient's baseline characteristics, clinical outcomes, and physiologic data. In
      case of acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial
      infarction, and ST-segment elevation myocardial infarction), only non-culprit vessel
      evaluation was used.
observational model: Cohort
time perspective: Prospective
measure: Major adverse cardiac events
time frame: 10 years
description: Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization
measure: Target vessel failure
time frame: 10 years
description: Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization
measure: Individual components of MACE and TVF
time frame: 10 years
description: Cumulative incidence of the individual components of MACE and TVF
arm group label: All patients
description: All lesions undergo assessment with coronary pressure sensor and either Doppler velocity or coronary thermodilution
intervention type: Diagnostic Test
intervention name: Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Coronary Flow Reserve, Microvascular resistance
description: Calculation of the resting mean distal coronary to aortic pressure ratio (resting Pd/Pa), fractional flow reserve (Pd/Pa at hyperemia), Coronary flow reserve (peak flow/resting flow), microvascular resistance (Pd/flow).
arm group label: All patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
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country: Denmark
country: Italy
country: Japan
country: Korea, Republic of
country: Netherlands
country: Spain
country: United States
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Tim van de Hoef
investigator title: M.D., Ph.D.
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: No
ipd description: Anonymized patient level data will be made available by the corresponding author for reasonable requests. Consent was not obtained for data sharing but the presented data are fully anonymized and risk of identification is negligible.