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PET-FDG in Myocarditis

Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography Imaging in Myocarditis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03777839
Acronym
PETMYO
Enrollment
25
Registered
2018-12-17
Start date
2018-11-20
Completion date
2024-08-31
Last updated
2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocarditis, Viral Myocarditis

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.

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.

Interventions

DIAGNOSTIC_TESTFDG PET/CT

FDG PET CT imaging with rest perfusion imaging

Sponsors

Montreal Heart Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity of FDG PET/CT imaging with rest perfusion imaging to detect myocarditis1 yearSensitivity of FDG-PET/CT with rest perfusion imaging

Secondary

MeasureTime frameDescription
Specificity and accuracy of FDG-PET/CT with rest perfusion imaging to detect myocarditis1 yearSpecificity and accuracy of FDG-PET/CT with rest perfusion imaging
Left ventricular ejection fraction1 yearThe association between subjects' outcome and quantitative assessment of left ventricular inflammation and scar will be evaluated

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026