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

NCT04085718 | Unknown

• 1 other identifier: STREAM
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myocarditis

Keywords

endomyocardial biopsy; myocarditis; anti-heart autoantibodies; biomarker; positron emission computed tomography; heart failure; cardiomyopathy; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Number of adverse events in the study group.

  3 months

• Correlation of FDG-PET/CT images with EMB results.

  baseline

• Correlation of FDG-PET/CT images with MRI and echo results.

  baseline

• Correlation of FDG-PET/CT images with MRI and echo results.

  3 months

• Correlation of FDG-PET/CT images with the concentration of biomarkers of fibrosis and myocardial necrosis.

  3 months

Study Arms (1)

Study arm

All included patients will undergo FDGPET/CT scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

50 patients with suspected myocarditis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Biospecimen

Retention: SAMPLES WITH DNA

serum stored at -80 degrees celsius

MeSH Terms

Conditions

Myocarditis; Heart Failure; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Marcin D Grabowski, Professor

  Medical University of Warsaw

  STUDY CHAIR

Central Study Contacts

Krzysztof Ozierański, PhD

CONTACT

22 5991958; krzysztof.ozieranski@gmail.com

Agata Tymińska, PhD

CONTACT

22 5991958; tyminska.agata@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2019
• First Posted: September 11, 2019
• Study Start: September 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 13, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after end of the study
• Access Criteria: External requests accepted by the study investigators