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FDG-PET/CT Images Comparing to MRI and Endomyocardial Biopsy in Myocarditis (STREAM)

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ClinicalTrials.gov Identifier: NCT04085718
Recruitment Status : Not yet recruiting
First Posted : September 11, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Krzysztof Ozieranski, Medical University of Warsaw

Brief Summary:

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.


Condition or disease
Myocarditis

Detailed Description:

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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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the feaSibility of FDG-PET/CT Images Comparing to MRI and Endomyocardial Biopsy Findings in clinicAlly Suspected Myocarditis
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort
Study arm
All included patients will undergo FDGPET/CT scan



Primary Outcome Measures :
  1. Sensitivity and specificity of FDG-PET/CT imaging in diagnosis of MC [ Time Frame: baseline ]
    assessment of sensitivity and specificity of FDG-PET/CT imaging in diagnosis of MC with baseline MRI as a reference


Secondary Outcome Measures :
  1. Number of adverse events in the study group. [ Time Frame: 3 months ]
    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.

  2. Correlation of FDG-PET/CT images with EMB results. [ Time Frame: baseline ]
    Correlation of FDG-PET/CT images with EMB results (presence of myocardial inflammation, fibrosis) in patients with clinical suspicion of MC.

  3. Correlation of FDG-PET/CT images with MRI and echo results. [ Time Frame: baseline ]
    Correlation of FDG-PET/CT images with MRI (EGE, LGE, edema) and echo (scar, function left and right ventricles) results assessed at baseline.

  4. Correlation of FDG-PET/CT images with MRI and echo results. [ Time Frame: 3 months ]
    Correlation of FDG-PET/CT images with MRI (EGE, LGE, edema) and echo (scar, function left and right ventricles) results assessed after 3 months.

  5. Correlation of FDG-PET/CT images with the concentration of biomarkers of fibrosis and myocardial necrosis. [ Time Frame: 3 months ]
    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.

  6. Correlation of FDG-PET/CT images with the presence and concentration of anti-heart autoantibodies. [ Time Frame: 3 months ]
    Correlation of FDG-PET/CT images with the presence and concentration of anti-heart autoantibodies evaluated at baseline and after 3 months.


Biospecimen Retention:   Samples With DNA
serum stored at -80 degrees celsius


Information from the National Library of Medicine

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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:   Probability Sample
Study Population
50 patients with suspected myocarditis
Criteria

Inclusion Criteria:

  • Signed informed consent (including consent for MRI, FDG-PET/CT and EMB)
  • Age ≥18 years
  • Clinically suspected MC (according to the 2013 Criteria of the ESC Working Group on Myocardial and Pericardial Diseases)
  • Symptoms associated with MC with a duration of <6 months
  • Women of childbearing potential must have a negative urine or blood pregnancy test

Exclusion Criteria:

  • Pregnancy or lactation
  • Any contraindication or intolerance to MRI or PET investigations (including but not limited to: presence of pacemakers not compatible with MRI, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body that would contraindicate an MRI scan)
  • Subjects with body mass index >45 kg/m2
  • Active neoplasm or diagnosed sarcoidosis

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): NCT04085718


Contacts
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Contact: Krzysztof Ozierański, PhD 22 5991958 ext +48 krzysztof.ozieranski@gmail.com
Contact: Agata Tymińska, PhD 22 5991958 ext +48 tyminska.agata@gmail.com

Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Study Chair: Marcin D Grabowski, Professor Medical University of Warsaw

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Responsible Party: Krzysztof Ozieranski, Principal Investigator, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT04085718     History of Changes
Other Study ID Numbers: STREAM
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: External requests for study data will be granted, however, any information that is shared will be blinded to any identifying participant information.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: after end of the study
Access Criteria: External requests accepted by the study investigators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Krzysztof Ozieranski, Medical University of Warsaw:
endomyocardial biopsy
myocarditis
anti-heart autoantibodies
biomarker
positron emission computed tomography
heart failure
cardiomyopathy
magnetic resonance imaging
Additional relevant MeSH terms:
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Myocarditis
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases