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PET-FDG in Myocarditis (PETMYO)

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ClinicalTrials.gov Identifier: NCT03777839
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Matthieu Pelletier-Galarneau, MD MSc, Montreal Heart Institute

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Myocarditis Viral Myocarditis Diagnostic Test: FDG PET/CT

Detailed Description:

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography Imaging in Myocarditis
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: FDG PET/CT
    FDG PET CT imaging with rest perfusion imaging

Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity of FDG PET/CT imaging with rest perfusion imaging to detect myocarditis [ Time Frame: 1 year ]
    Sensitivity of FDG-PET/CT with rest perfusion imaging


Secondary Outcome Measures :
  1. Specificity and accuracy of FDG-PET/CT with rest perfusion imaging to detect myocarditis [ Time Frame: 1 year ]
    Specificity and accuracy of FDG-PET/CT with rest perfusion imaging

  2. Left ventricular ejection fraction [ Time Frame: 1 year ]
    The association between subjects' outcome and quantitative assessment of left ventricular inflammation and scar will be evaluated


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A total of 50 subjects with high clinical suspicion of myocarditis will be enrolled.
Criteria

Inclusion Criteria:

  1. 18 years of age or older

  2. Clinical suspicion of myocarditis due to findings such as:

    1. Symptoms and signs of myocarditis such as dyspnea, orthopnea, palpitation, and chest pain, without other identifiable cause
    2. New onset of cardiovascular symptoms with recent history of viral disease or previous myocarditis
    3. Unexplained new onset of left ventricular dysfunction
    4. Unexplained elevated troponin
    5. Magnetic resonance imaging findings suggestive of myocarditis, such as late gadolinium enhancement and edema
    6. Biopsy findings compatible with myocarditis
  3. Women of childbearing potential must have a negative urine or blood pregnancy test
  4. Capable of giving informed consent and the consent must be obtained prior to any study related procedures
  5. Subject's with body mass index inferior or equal to 45 kg/m2

Exclusion Criteria:

  1. Female subject who is pregnant or breastfeeding and unwilling to stop for 24h
  2. Claustrophobia or inability to lie still in a supine position for imaging purposes
  3. Unwillingness or inability to provide informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777839


Contacts
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Contact: Matthieu Pelletier-Galarneau, MD MSc FRCPC 15143763330 ext 4418 matthieu.pelletier-galarneau@icm-mhi.org
Contact: Francois Harel, MD PhD 5143763330 francois_harel@hotmail.com

Locations
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Canada, Quebec
Matthieu Pelletier-Galarneau Recruiting
Montreal, Quebec, Canada, H3L3C1
Contact: Matthieu Pelletier-Galarneau, MD MSc FRCPC    5143763330 ext 4418    matthieu.pelletier-galarneau@icm-mhi.org   
Sponsors and Collaborators
Montreal Heart Institute
More Information
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Responsible Party: Matthieu Pelletier-Galarneau, MD MSc, Adjunct Professor of Clinic, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT03777839    
Other Study ID Numbers: 2019-2395
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocarditis
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases