MyocarditisSTREAMNCT04085718
FDG-PET/CT Images Comparing to MRI and Endomyocardial Biopsy in Myocarditis
An observational study of Myocarditis, run by Medical University of Warsaw.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocarditis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50 patients with suspected myocarditis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the feaSibility of FDG-PET/CT Images Comparing to MRI and Endomyocardial Biopsy Findings in clinicAlly Suspected Myocarditis
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.
Read the 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.
- Conditions
- Myocarditis
- Keywords
- endomyocardial biopsy, myocarditis, anti-heart autoantibodies, biomarker, positron emission computed tomography, heart failure, cardiomyopathy, magnetic resonance imaging
- Medical subject headings
- Myocarditis, Heart Failure, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | All included patients will undergo FDGPET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (6)
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.
Measured: 3 months
Correlation of FDG-PET/CT images with EMB results.
Correlation of FDG-PET/CT images with EMB results (presence of myocardial inflammation, fibrosis) in patients with clinical suspicion of MC.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study startSep 2019 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krzysztof Ozieranski, Medical University of Warsaw
- Investigators
- Marcin D Grabowski, Professor, Study chair, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085718
- Sponsor's protocol ID
- STREAM
- Acronym
- STREAM
- Status last verified
- Sep 2019
- First submitted
- 8 Sep 2019
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: External requests for study data will be granted, however, any information that is shared will be blinded to any identifying participant information.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the feaSibility of FDG-PET/CT Images Comparing to MRI and Endomyocardial Biopsy Findings in clinicAlly Suspected Myocarditis
- ClinicalTrials.gov ID
- NCT04085718
- Acronym / sponsor ID
- STREAM / STREAM
- Conditions
- Myocarditis
- Keywords
- endomyocardial biopsy, myocarditis, anti-heart autoantibodies, biomarker, positron emission computed tomography, heart failure, cardiomyopathy, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | – | –All included patients will undergo FDGPET/CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients with suspected myocarditis
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Number of adverse events in the study group.
Time frame: 3 months
Correlation of FDG-PET/CT images with EMB results.
Time frame: baseline
Correlation of FDG-PET/CT images with MRI and echo results.
Time frame: baseline
Correlation of FDG-PET/CT images with MRI and echo results.
Time frame: 3 months
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 presence and concentration of anti-heart autoantibodies.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Individual participant dataSharing planned: Yes. External requests for study data will be granted, however, any information that is shared will be blinded to any identifying participant information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcin D Grabowski, Professor study chair
Medical University of Warsaw
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis, run by Medical University of Warsaw.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krzysztof Ozierański, PhD (22 5991958 ext. +48, krzysztof.ozieranski@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of FDG-PET/CT imaging in diagnosis of MC (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.