MyocarditisPETMYONCT03777839
PET-FDG in Myocarditis
An observational study of Myocarditis and Viral Myocarditis, run by Montreal Heart Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocarditis, Viral Myocarditis
- What is being tested?
- FDG PET/CT
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 20 Nov 2018to 31 Aug 2024
- 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: A total of 50 subjects with high clinical suspicion of myocarditis will be enrolled.
Who may be able to join
- 18 years of age or older
- Clinical suspicion of myocarditis due to findings such as:
- Symptoms and signs of myocarditis such as dyspnea, orthopnea, palpitation, and chest pain, without other identifiable cause
- New onset of cardiovascular symptoms with recent history of viral disease or previous myocarditis
- Unexplained new onset of left ventricular dysfunction
- Unexplained elevated troponin
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- Magnetic resonance imaging findings suggestive of myocarditis, such as late gadolinium enhancement and edema
- Biopsy findings compatible with myocarditis
- Women of childbearing potential must have a negative urine or blood pregnancy test
- Capable of giving informed consent and the consent must be obtained prior to any study related procedures
- Subject's with body mass index inferior or equal to 45 kg/m2
Who cannot join
- Female subject who is pregnant or breastfeeding and unwilling to stop for 24h
- Claustrophobia or inability to lie still in a supine position for imaging purposes
- Unwillingness or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography Imaging in Myocarditis
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.
Read the 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.
- Conditions
- Myocarditis, Viral Myocarditis
- Being tested
- FDG PET/CT
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG PET/CTDiagnostic test
FDG PET CT imaging with rest perfusion imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of FDG PET/CT imaging with rest perfusion imaging to detect myocarditis
Sensitivity of FDG-PET/CT with rest perfusion imaging
Measured: 1 year
Secondary outcomes (2)
Specificity and accuracy of FDG-PET/CT with rest perfusion imaging to detect myocarditis
Specificity and accuracy of FDG-PET/CT with rest perfusion imaging
Measured: 1 year
Left ventricular ejection fraction
The association between subjects' outcome and quantitative assessment of left ventricular inflammation and scar will be evaluated
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start20 Nov 2018
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
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.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthieu Pelletier-Galarneau, MD MSc, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777839
- Sponsor's protocol ID
- 2019-2395
- Acronym
- PETMYO
- Status last verified
- Oct 2023
- First submitted
- 13 Dec 2018
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography Imaging in Myocarditis
- ClinicalTrials.gov ID
- NCT03777839
- Acronym / sponsor ID
- PETMYO / 2019-2395
- Conditions
- Myocarditis, Viral Myocarditis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 17 Dec 2018 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 50 subjects with high clinical suspicion of myocarditis will be enrolled.
Key inclusion criteria (11 listed)
- 18 years of age or older
- Clinical suspicion of myocarditis due to findings such as:
- Women of childbearing potential must have a negative urine or blood pregnancy test
- Capable of giving informed consent and the consent must be obtained prior to any study related procedures
- Subject's with body mass index inferior or equal to 45 kg/m2
Key exclusion criteria (3 listed)
- Female subject who is pregnant or breastfeeding and unwilling to stop for 24h
- Claustrophobia or inability to lie still in a supine position for imaging purposes
- Unwillingness or inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDG PET/CTFDG PET CT imaging with rest perfusion imaging | Diagnostic test | – |
Primary outcome
Sensitivity of FDG PET/CT imaging with rest perfusion imaging to detect myocarditis
Time frame: 1 year
Sensitivity of FDG-PET/CT with rest perfusion imaging
2 secondary outcomes
Specificity and accuracy of FDG-PET/CT with rest perfusion imaging to detect myocarditis
Time frame: 1 year
Left ventricular ejection fraction
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis and Viral Myocarditis, run by Montreal Heart Institute at 1 site in Canada.
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 11 inclusion and 3 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: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of FDG PET/CT imaging with rest perfusion imaging to detect myocarditis (time frame: 1 year). 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 22 Nov 2024.