xml: <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/NCT06008041</url>
    </required_header>
    <id_info>
      <org_study_id>29BRC23.0037 - PHYCO</org_study_id>
      <nct_id>NCT06008041</nct_id>
    </id_info>
    <brief_title>Multimodal Epicardial and Endocardial COronary PHYsiological Evaluation in Pathological Situations (PHYCO)</brief_title>
    <acronym>PHYCO</acronym>
    <official_title>Multimodal Epicardial and Endocardial COronary PHYsiological Evaluation in Pathological Situations</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Brest</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Brest</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>
        When performing coronary angiography in a stable situation, the identification of an&#xD;
        intermediate coronary lesion (between 50 and 70%) is common, and requires additional&#xD;
        functional evaluation. The gold standard for this evaluation is Fractional Flow Reserve&#xD;
        (FFR). FFR is a flow ratio transformed into a pressure ratio by simplification, neglecting&#xD;
        some parameters, especially microcirculatory resistance.&#xD;
  &#xD;
        The aim of this study is to investigate hemodynamic and structural assessment induced in&#xD;
        specific conditions, and their repercussion on functional assessment by FFR to implement the&#xD;
        diagnostic approach and personalize it for each patient.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 13, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2027</completion_date>
    <primary_completion_date type="Actual">July 13, 2023</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>Index of Microcirculatory Resistance (IMR)</measure>
      <time_frame>During coronary angiography</time_frame>
      <description>IMR = Pd x Tmn at maximal hyperhemia Normal range &lt; 25</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Fractional Flow Reserve (FFR)</measure>
      <time_frame>During coronary angiography</time_frame>
      <description>FFR = Pd/Pa at maximal hyperhemia Normal value &gt; 0.80</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Coronary Flow Reserve (CFR)</measure>
      <time_frame>During coronary angiography</time_frame>
      <description>CFR = Hyperhemic flow / Resting flow Normal value &gt; 2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Resting Full cycle Ratio (RFR)</measure>
      <time_frame>During coronary angiography</time_frame>
      <description>Lowest Pd/Pa value in systole and diastole (mean of 5 consecutive cardiac cycles) Normal value &gt; 0.80</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quantitative Flow Ratio (QFR)</measure>
      <time_frame>During coronary angiography</time_frame>
      <description>Normal value &gt; 0.80</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Angio-IMR</measure>
      <time_frame>During coronary angiography</time_frame>
      <description>Estimated hyperemic Pa × angio-FFR × [vessel length/(K × Vdiastole)] Normal value &lt; 25</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Death</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Angina pectoris (CCS)</measure>
      <time_frame>12 months</time_frame>
      <description>Grade I : Angina with strenuous or rapid or prolonged exertion at work or recreation Grade II : Slight limitation of ordinary activity Grade III : Marked limitation of ordinary physical activity Grade IV : Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest</description>
    </secondary_outcome>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Coronary Artery Disease</condition>
    <condition>Coronary Microvascular Dysfunction</condition>
    <eligibility>
      <study_pop>
        <textblock>
          -  Diabetes mellitus&#xD;
  &#xD;
            -  High blood pressure&#xD;
  &#xD;
            -  Aortic stenosis&#xD;
  &#xD;
            -  Hypertrophic cardiopathy&#xD;
  &#xD;
            -  Dilated cardiopathy&#xD;
  &#xD;
            -  Stress cardiopathy&#xD;
  &#xD;
            -  Elderly people &gt; 75 years old&#xD;
  &#xD;
            -  Acute coronary syndrome&#xD;
  &#xD;
            -  Preserved heart failure&#xD;
  &#xD;
            -  Cardiac amyloidosis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Intermediate coronary lesion (between 50 and 70%)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Hemodynamic instability&#xD;
  &#xD;
            -  Adenosine hypersensitivity&#xD;
  &#xD;
            -  Asthma&#xD;
  &#xD;
            -  Severe chronic obstructive pulmonary disease&#xD;
  &#xD;
            -  Long QTc&#xD;
  &#xD;
            -  Wolff parkinson white&#xD;
  &#xD;
            -  High degree atriovenricular block&#xD;
  &#xD;
            -  Left-right shunt&#xD;
  &#xD;
            -  Carotid artery stenosis with hemodynamic insufficiency&#xD;
  &#xD;
            -  Pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Chu Brest</name>
        <address>
          <city>Brest</city>
          <zip>29609</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Coronary Artery Disease</keyword>
    <keyword>Coronary Physiology</keyword>
    <keyword>Index of Microcirculatory Resistance (IMR)</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>Yes</sharing_ipd>
      <ipd_description>All collected data that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Data will be available beginning three years and ending fifteen years following the final study report completion</ipd_time_frame>
      <ipd_access_criteria>Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008041
  org study id: 29BRC23.0037 - PHYCO
  nct id: NCT06008041
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  When performing coronary angiography in a stable situation, the identification of an
        intermediate coronary lesion (between 50 and 70%) is common, and requires additional
        functional evaluation. The gold standard for this evaluation is Fractional Flow Reserve
        (FFR). FFR is a flow ratio transformed into a pressure ratio by simplification, neglecting
        some parameters, especially microcirculatory resistance.
  
        The aim of this study is to investigate hemodynamic and structural assessment induced in
        specific conditions, and their repercussion on functional assessment by FFR to implement the
        diagnostic approach and personalize it for each patient.
  observational model: Cohort
  time perspective: Prospective
  measure: Index of Microcirculatory Resistance (IMR)
  time frame: During coronary angiography
  description: IMR = Pd x Tmn at maximal hyperhemia Normal range < 25
  measure: Fractional Flow Reserve (FFR)
  time frame: During coronary angiography
  description: FFR = Pd/Pa at maximal hyperhemia Normal value > 0.80
  measure: Coronary Flow Reserve (CFR)
  time frame: During coronary angiography
  description: CFR = Hyperhemic flow / Resting flow Normal value > 2
  measure: Resting Full cycle Ratio (RFR)
  time frame: During coronary angiography
  description: Lowest Pd/Pa value in systole and diastole (mean of 5 consecutive cardiac cycles) Normal value > 0.80
  measure: Quantitative Flow Ratio (QFR)
  time frame: During coronary angiography
  description: Normal value > 0.80
  measure: Angio-IMR
  time frame: During coronary angiography
  description: Estimated hyperemic Pa × angio-FFR × [vessel length/(K × Vdiastole)] Normal value < 25
  measure: Death
  time frame: 12 months
  measure: Angina pectoris (CCS)
  time frame: 12 months
  description: Grade I : Angina with strenuous or rapid or prolonged exertion at work or recreation Grade II : Slight limitation of ordinary activity Grade III : Marked limitation of ordinary physical activity Grade IV : Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Coronary Disease
  sharing ipd: Yes
  ipd description: All collected data that underlie results in a publication
  ipd info type: Study Protocol
  ipd time frame: Data will be available beginning three years and ending fifteen years following the final study report completion
  ipd access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.