<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/NCT03777839</url>
  </required_header>
  <id_info>
    <org_study_id>2019-2395</org_study_id>
    <nct_id>NCT03777839</nct_id>
  </id_info>
  <brief_title>PET-FDG in Myocarditis</brief_title>
  <acronym>PETMYO</acronym>
  <official_title>Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography Imaging in Myocarditis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montreal Heart Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montreal Heart Institute</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 diagnostic performance of 18F-2-fluoro-2-deoxy-D-glucose&#xD;
      fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) with rest&#xD;
      perfusion imaging for the diagnosis of myocarditis. Patients with clinical suspicion of&#xD;
      myocarditis will be recruited and undergo a rest myocardial perfusion scan and a FDG PET/CT&#xD;
      scan following a myocardial suppression protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Myocarditis is characterized by myocardial inflammation, which can lead to fibrosis and heart&#xD;
      failure.&#xD;
&#xD;
      FDG PET/CT, with appropriate suppression protocol including high-fat-low-carbohydrate diet,&#xD;
      fasting, and IV heparin, can be use to detect myocardial inflammation. It is frequently used&#xD;
      for the diagnosis of inflammation in cardiac sarcoidosis. After the initial inflammatory&#xD;
      phase, inflammation resolves and fibrosis can seen. Resting perfusion imaging will allow&#xD;
      identification of fibrosis. The combination of FDG PET/CT and rest perfusion imaging could&#xD;
      allow detection of the various phases of myocarditis; inflammation and fibrosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 20, 2018</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Sensitivity of FDG PET/CT imaging with rest perfusion imaging to detect myocarditis</measure>
    <time_frame>1 year</time_frame>
    <description>Sensitivity of FDG-PET/CT with rest perfusion imaging</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specificity and accuracy of FDG-PET/CT with rest perfusion imaging to detect myocarditis</measure>
    <time_frame>1 year</time_frame>
    <description>Specificity and accuracy of FDG-PET/CT with rest perfusion imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left ventricular ejection fraction</measure>
    <time_frame>1 year</time_frame>
    <description>The association between subjects' outcome and quantitative assessment of left ventricular inflammation and scar will be evaluated</description>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Myocarditis</condition>
  <condition>Viral Myocarditis</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>FDG PET/CT</intervention_name>
    <description>FDG PET CT imaging with rest perfusion imaging</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 50 subjects with high clinical suspicion of myocarditis will be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years of age or older&#xD;
&#xD;
          2. Clinical suspicion of myocarditis due to findings such as:&#xD;
&#xD;
               1. Symptoms and signs of myocarditis such as dyspnea, orthopnea, palpitation, and&#xD;
                  chest pain, without other identifiable cause&#xD;
&#xD;
               2. New onset of cardiovascular symptoms with recent history of viral disease or&#xD;
                  previous myocarditis&#xD;
&#xD;
               3. Unexplained new onset of left ventricular dysfunction&#xD;
&#xD;
               4. Unexplained elevated troponin&#xD;
&#xD;
               5. Magnetic resonance imaging findings suggestive of myocarditis, such as late&#xD;
                  gadolinium enhancement and edema&#xD;
&#xD;
               6. Biopsy findings compatible with myocarditis&#xD;
&#xD;
          3. Women of childbearing potential must have a negative urine or blood pregnancy test&#xD;
&#xD;
          4. Capable of giving informed consent and the consent must be obtained prior to any study&#xD;
             related procedures&#xD;
&#xD;
          5. Subject's with body mass index inferior or equal to 45 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female subject who is pregnant or breastfeeding and unwilling to stop for 24h&#xD;
&#xD;
          2. Claustrophobia or inability to lie still in a supine position for imaging purposes&#xD;
&#xD;
          3. Unwillingness or inability to provide informed consent&#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>Matthieu Pelletier-Galarneau, MD MSc FRCPC</last_name>
    <phone>15143763330</phone>
    <phone_ext>4418</phone_ext>
    <email>matthieu.pelletier-galarneau@icm-mhi.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Francois Harel, MD PhD</last_name>
    <phone>5143763330</phone>
    <email>francois_harel@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Matthieu Pelletier-Galarneau</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3L3C1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthieu Pelletier-Galarneau, MD MSc FRCPC</last_name>
      <phone>5143763330</phone>
      <phone_ext>4418</phone_ext>
      <email>matthieu.pelletier-galarneau@icm-mhi.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>March 10, 2021</last_update_submitted>
  <last_update_submitted_qc>March 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montreal Heart Institute</investigator_affiliation>
    <investigator_full_name>Matthieu Pelletier-Galarneau, MD MSc</investigator_full_name>
    <investigator_title>Adjunct Professor of Clinic</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocarditis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03777839
org study id: 2019-2395
nct id: NCT03777839
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the diagnostic performance of 18F-2-fluoro-2-deoxy-D-glucose
      fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) with rest
      perfusion imaging for the diagnosis of myocarditis. Patients with clinical suspicion of
      myocarditis will be recruited and undergo a rest myocardial perfusion scan and a FDG PET/CT
      scan following a myocardial suppression protocol.
Myocarditis is characterized by myocardial inflammation, which can lead to fibrosis and heart
      failure.

      FDG PET/CT, with appropriate suppression protocol including high-fat-low-carbohydrate diet,
      fasting, and IV heparin, can be use to detect myocardial inflammation. It is frequently used
      for the diagnosis of inflammation in cardiac sarcoidosis. After the initial inflammatory
      phase, inflammation resolves and fibrosis can seen. Resting perfusion imaging will allow
      identification of fibrosis. The combination of FDG PET/CT and rest perfusion imaging could
      allow detection of the various phases of myocarditis; inflammation and fibrosis.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity of FDG PET/CT imaging with rest perfusion imaging to detect myocarditis
time frame: 1 year
description: Sensitivity of FDG-PET/CT with rest perfusion imaging
measure: Specificity and accuracy of FDG-PET/CT with rest perfusion imaging to detect myocarditis
time frame: 1 year
description: Specificity and accuracy of FDG-PET/CT with rest perfusion imaging
measure: Left ventricular ejection fraction
time frame: 1 year
description: The association between subjects' outcome and quantitative assessment of left ventricular inflammation and scar will be evaluated
intervention type: Diagnostic Test
intervention name: FDG PET/CT
description: FDG PET CT imaging with rest perfusion imaging
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthieu Pelletier-Galarneau, MD MSc FRCPC
phone: 15143763330
phone ext: 4418
email: matthieu.pelletier-galarneau@icm-mhi.org
last name: Francois Harel, MD PhD
phone: 5143763330
email: francois_harel@hotmail.com
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Montreal Heart Institute
investigator full name: Matthieu Pelletier-Galarneau, MD MSc
investigator title: Adjunct Professor of Clinic
mesh term: Myocarditis
sharing ipd: Undecided