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Fifty hospitalized consecutive patients with clinically suspected myocarditis (MC) who meet the inclusion/exclusion criteria will be enrolled to the study.
During index hospitalization patients will undergo a standard clinical evaluation (physical examination, collection of a medical history, blood tests (including troponin, N-terminal-pro Brain Natriuretic Peptide (NTproBNP), C-reactive protein (CRP), Suppression of Tumorigenicity 2 (ST2), Galectin-3), 24-h Holter ECG, echo, coronary angiography, magnetic resonance imaging (MRI)). Women of childbearing potential will undergo a pregnancy test prior to radiological examinations. After signing the informed consent patients will undergo resting single photon emission computed tomography (SPECT) to assess possible myocardial perfusion defects and then 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography/computed tomography FDG-PET/CT. After MRI and FDG-PET/CT tests patients will undergo right ventricular endomyocardial biopsy (EMB) (5-8 myocardial tissue samples). Blood biomarkers of fibrosis and myocardial necrosis, as well as anticardiac autoantibodies will be evaluated at baseline and after 3 months (serum will be stored at -80 °C for final evaluation). After 3-months from enrollment follow-up visit will be performed with clinical evaluation. All patients will undergo physical examination, collection of a medical history, blood tests, 24-h Holter ECG, echo, MRI.
Fifty hospitalized consecutive patients with clinically suspected MC who meet the inclusion/exclusion criteria will be enrolled to the study.
During index hospitalization patients will undergo a standard clinical evaluation (physical examination, collection of a medical history, blood tests (including troponin, N-terminal-pro Brain Natriuretic Peptide (NTproBNP), C-reactive protein (CRP), Suppression of Tumorigenicity 2 (ST2), Galectin-3), 24-h Holter ECG, echo, coronary angiography, MRI). Women of childbearing potential will undergo a pregnancy test prior to radiological examinations. After signing the informed consent patients will undergo resting single photon emission computed tomography (SPECT) to assess possible myocardial perfusion defects and then cardiac FDG-PET/CT. After MRI and FDG-PET/CT tests patients will undergo right ventricular EMB (5-8 myocardial tissue samples). Blood biomarkers of fibrosis and myocardial necrosis, as well as anti-heart autoantibodies will be evaluated at baseline and after 3 months (serum will be stored at -80 °C for final evaluation). After 3-months from enrollment follow-up visit will be performed with clinical evaluation. All patients will undergo physical examination, collection of a medical history, blood tests, 24-h Holter ECG, echo, MRI.
FDG-PET/CT imaging Resting SPECT will be performed one day before the FDG-PET/CT examination. Physiological glucose uptake in the myocardium will be suppressed using dietary preparation (low-carbohydrate high-fatty diet). 48 h before the FDG-PET/CT examination, all patients' meals will be low-carbohydrate. 24 h before the FDG-PET/CT examination (the "SPECT day"), breakfast and dinner (last meal at 4:00 PM) will be high-fat, then fasting (a patient should drink only still water) until FDG-PET/CT examination in the next morning (9:00 PM). Single-dose heparin will be administered intravenously at a low dose (50 IU/kg) 15 minutes before the start of the FDG-PET/CT examination to increase the accuracy of the test. Capillary blood glucose level will be measured 20 minutes before the FDG-PET/CT examination.
Because of radiation, for about 6 h after the scan patients should avoid contact with children and pregnant women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | All included patients will undergo FDGPET/CT scan |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of FDG-PET/CT imaging in diagnosis of MC | assessment of sensitivity and specificity of FDG-PET/CT imaging in diagnosis of MC with baseline MRI as a reference | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events in the study group. | Association of FDG-PET/CT images with occurrence of heart failure, heart failure hospitalizations, heart failure outpatients visits, MC recurrence, heart transplantation, ventricular or supraventricular arrhythmias. | 3 months |
| Correlation of FDG-PET/CT images with EMB results. |
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Inclusion Criteria:
Exclusion Criteria:
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50 patients with suspected myocarditis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Krzysztof Ozierański, PhD | Contact | 22 5991958 | +48 | krzysztof.ozieranski@gmail.com |
| Agata Tymińska, PhD | Contact | 22 5991958 | +48 | tyminska.agata@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marcin D Grabowski, Professor | Medical University of Warsaw | Study Chair |
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External requests for study data will be granted, however, any information that is shared will be blinded to any identifying participant information.
after end of the study
External requests accepted by the study investigators
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| ID | Term |
|---|---|
| D009205 | Myocarditis |
| D006333 | Heart Failure |
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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serum stored at -80 degrees celsius
Correlation of FDG-PET/CT images with EMB results (presence of myocardial inflammation, fibrosis) in patients with clinical suspicion of MC. |
| baseline |
| Correlation of FDG-PET/CT images with MRI and echo results. | Correlation of FDG-PET/CT images with MRI (EGE, LGE, edema) and echo (scar, function left and right ventricles) results assessed at baseline. | baseline |
| Correlation of FDG-PET/CT images with MRI and echo results. | Correlation of FDG-PET/CT images with MRI (EGE, LGE, edema) and echo (scar, function left and right ventricles) results assessed after 3 months. | 3 months |
| Correlation of FDG-PET/CT images with the concentration of biomarkers of fibrosis and myocardial necrosis. | Correlation of FDG-PET/CT images with the concentration of biomarkers of fibrosis and myocardial necrosis (troponin, N-terminal-pro Brain Natriuretic Peptide (NTproBNP), C-reactive protein (CRP), Suppression of Tumorigenicity 2 (ST2), Galectin-3) evaluated at baseline and after 3 months. | 3 months |
| Correlation of FDG-PET/CT images with the presence and concentration of anti-heart autoantibodies. | Correlation of FDG-PET/CT images with the presence and concentration of anti-heart autoantibodies evaluated at baseline and after 3 months. | 3 months |