Myocarditis Clinical Trial
— PETMYOOfficial title:
Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography Imaging in Myocarditis
NCT number | NCT03777839 |
Other study ID # | 2019-2395 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 20, 2018 |
Est. completion date | August 1, 2023 |
Verified date | October 2023 |
Source | Montreal Heart Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | August 1, 2023 |
Est. primary completion date | August 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Matthieu Pelletier-Galarneau | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Montreal Heart Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of FDG PET/CT imaging with rest perfusion imaging to detect myocarditis | Sensitivity of FDG-PET/CT with rest perfusion imaging | 1 year | |
Secondary | Specificity and accuracy of FDG-PET/CT with rest perfusion imaging to detect myocarditis | Specificity and accuracy of FDG-PET/CT with rest perfusion imaging | 1 year | |
Secondary | Left ventricular ejection fraction | The association between subjects' outcome and quantitative assessment of left ventricular inflammation and scar will be evaluated | 1 year |
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