<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/NCT04451551</url>
  </required_header>
  <id_info>
    <org_study_id>15O-H2O PET Cohort</org_study_id>
    <nct_id>NCT04451551</nct_id>
  </id_info>
  <brief_title>Myocardial Perfusion Imaging by 15O-H2O PET/CT</brief_title>
  <official_title>Myocardial Perfusion Imaging by 15O-H2O PET/CT: Reference Values and Prognostic Value</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</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>
      The trial will include 2500 patients with evident or suspected ischemic heart disease refered&#xD;
      to Department of Nuclear Medicine &amp; PET Centre, Aarhus University Hospital, for perfusion&#xD;
      imaging by 15O-H2O PET/CT scan of the heart during rest and stress. The patients will undergo&#xD;
      the clinical scan as normal.&#xD;
&#xD;
      Data from the scans will be used to determine reference values of the examination.&#xD;
&#xD;
      Follow up will be done for up to 10 years in regards to major cardiovascular events in order&#xD;
      to determine the prognostic value of the scan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2033</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2023</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>10 Years</target_duration>
  <primary_outcome>
    <measure>Prognostic value within 10 years</measure>
    <time_frame>10 years</time_frame>
    <description>Number of participants who experience a major adverse cardiac event within 10 years of follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Myocardial blood flow</measure>
    <time_frame>5 Years</time_frame>
    <description>The myocardial blood flow of participants assessed by 15O-H2O PET/CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coronary flow reserve</measure>
    <time_frame>5 Years</time_frame>
    <description>The coronary flow reserve of participants assessed by 15O-H2O PET/CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary transit time</measure>
    <time_frame>5 Years</time_frame>
    <description>The pulmonary transit time of participants assessed by 15O-H2O PET/CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left ventricular end-systolic volume</measure>
    <time_frame>5 Years</time_frame>
    <description>The left ventricular end-systolic volume of participants assessed by 15O-H2O PET/CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left ventricular end-diastolic volume</measure>
    <time_frame>5 Years</time_frame>
    <description>The left ventricular end-diastolic volume of participants assessed by 15O-H2O PET/CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right ventricular end-systolic volume</measure>
    <time_frame>5 Years</time_frame>
    <description>The right ventricular end-systolic volume of participants assessed by 15O-H2O PET/CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right ventricular end-diastolic volume</measure>
    <time_frame>5 Years</time_frame>
    <description>The right ventricular end-diastolic volume of participants assessed by 15O-H2O PET/CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate coronary angiography followup</measure>
    <time_frame>5 years</time_frame>
    <description>Number of participants who undergo coronary angiography within 3 months after primary 15O-H2O PET/CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate percutaneous coronary intervention (PCI) followup</measure>
    <time_frame>5 years</time_frame>
    <description>Number of participants who undergo percutaneous coronary intervention within 3 months after primary 15O-H2O PET/CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate coronary artery bypass graft (CABG) followup</measure>
    <time_frame>5 years</time_frame>
    <description>Number of participants who undergo coronary artery bypass graft within 3 months after primary 15O-H2O PET/CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prognostic value within 5 years</measure>
    <time_frame>5 years</time_frame>
    <description>Number of participants who experience a major adverse cardiac event within 5 years of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prognostic value within 2 years</measure>
    <time_frame>2 years</time_frame>
    <description>Number of participants who experience a major adverse cardiac event within 2 years of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prognostic value within 1 years</measure>
    <time_frame>1 years</time_frame>
    <description>Number of participants who experience a major adverse cardiac event within 1 years of follow-up.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">2500</enrollment>
  <condition>Ischemic Heart Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Any patient with known or suspected ischemic heart disease referred for a clinical H2O-PET&#xD;
        at Department of Nuclear Medicine and PET Centre, Aarhus University Hospital, not meeting&#xD;
        any exclusion criteria will be enrolled in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Known or suspected ischemic heart disease referred for a clinical H2O-PET at&#xD;
             Department of Nuclear Medicine and PET Centre, Aarhus University Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Claustrophobia, severe asthma, younger than 18 years&#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_contact>
    <last_name>Simon Madsen, MD</last_name>
    <phone>4520140596+</phone>
    <email>simmas@rm.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <state>Aarhus N</state>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simon Madsen</last_name>
      <email>simmas@rm.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>December 21, 2022</last_update_submitted>
  <last_update_submitted_qc>December 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myocardial Perfusion Imaging</keyword>
  <keyword>Positron-Emission Tomography</keyword>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Coronary Flow Reserve</keyword>
  <keyword>Myocardial Blood Flow</keyword>
  <keyword>Prognosis</keyword>
  <keyword>Reference Value</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery 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/NCT04451551
org study id: 15O-H2O PET Cohort
nct id: NCT04451551
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The trial will include 2500 patients with evident or suspected ischemic heart disease refered
      to Department of Nuclear Medicine & PET Centre, Aarhus University Hospital, for perfusion
      imaging by 15O-H2O PET/CT scan of the heart during rest and stress. The patients will undergo
      the clinical scan as normal.

      Data from the scans will be used to determine reference values of the examination.

      Follow up will be done for up to 10 years in regards to major cardiovascular events in order
      to determine the prognostic value of the scan.
observational model: Cohort
time perspective: Prospective
measure: Prognostic value within 10 years
time frame: 10 years
description: Number of participants who experience a major adverse cardiac event within 10 years of follow-up.
measure: Myocardial blood flow
time frame: 5 Years
description: The myocardial blood flow of participants assessed by 15O-H2O PET/CT
measure: Coronary flow reserve
time frame: 5 Years
description: The coronary flow reserve of participants assessed by 15O-H2O PET/CT
measure: Pulmonary transit time
time frame: 5 Years
description: The pulmonary transit time of participants assessed by 15O-H2O PET/CT
measure: Left ventricular end-systolic volume
time frame: 5 Years
description: The left ventricular end-systolic volume of participants assessed by 15O-H2O PET/CT
measure: Left ventricular end-diastolic volume
time frame: 5 Years
description: The left ventricular end-diastolic volume of participants assessed by 15O-H2O PET/CT
measure: Right ventricular end-systolic volume
time frame: 5 Years
description: The right ventricular end-systolic volume of participants assessed by 15O-H2O PET/CT
measure: Right ventricular end-diastolic volume
time frame: 5 Years
description: The right ventricular end-diastolic volume of participants assessed by 15O-H2O PET/CT
measure: Immediate coronary angiography followup
time frame: 5 years
description: Number of participants who undergo coronary angiography within 3 months after primary 15O-H2O PET/CT
measure: Immediate percutaneous coronary intervention (PCI) followup
time frame: 5 years
description: Number of participants who undergo percutaneous coronary intervention within 3 months after primary 15O-H2O PET/CT
measure: Immediate coronary artery bypass graft (CABG) followup
time frame: 5 years
description: Number of participants who undergo coronary artery bypass graft within 3 months after primary 15O-H2O PET/CT
measure: Prognostic value within 5 years
time frame: 5 years
description: Number of participants who experience a major adverse cardiac event within 5 years of follow-up.
measure: Prognostic value within 2 years
time frame: 2 years
description: Number of participants who experience a major adverse cardiac event within 2 years of follow-up.
measure: Prognostic value within 1 years
time frame: 1 years
description: Number of participants who experience a major adverse cardiac event within 1 years of follow-up.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Simon Madsen, MD
phone: 4520140596+
email: simmas@rm.dk
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease