Clinical trial NCT03777839: PET-FDG in Myocarditis
Official title: Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography Imaging in Myocarditis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocarditis
Viral Myocarditis
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 50 subjects with high clinical suspicion of myocarditis will be enrolled.

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.

Eligibility 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

Primary outcomes:
measure: Sensitivity of FDG PET/CT imaging with rest perfusion imaging to detect myocarditis
timeFrame: 1 year
Secondary outcomes:
measure: Specificity and accuracy of FDG-PET/CT with rest perfusion imaging to detect myocarditis
timeFrame: 1 year
measure: Left ventricular ejection fraction
timeFrame: 1 year
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Matthieu Pelletier-Galarneau
state: Quebec
Study officials:
References: