PET-FDG in Myocarditis
PETMYO
Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography Imaging in Myocarditis
1 other identifier
observational
25
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 20, 2018
CompletedFirst Submitted
Initial submission to the registry
December 13, 2018
CompletedFirst Posted
Study publicly available on registry
December 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedNovember 22, 2024
October 1, 2023
5.8 years
December 13, 2018
November 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity of FDG PET/CT imaging with rest perfusion imaging to detect myocarditis
Sensitivity of FDG-PET/CT with rest perfusion imaging
1 year
Secondary Outcomes (2)
Specificity and accuracy of FDG-PET/CT with rest perfusion imaging to detect myocarditis
1 year
Left ventricular ejection fraction
1 year
Interventions
FDG PET CT imaging with rest perfusion imaging
Eligibility Criteria
A total of 50 subjects with high clinical suspicion of myocarditis will be enrolled.
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Matthieu Pelletier-Galarneau
Montreal, Quebec, H3L3C1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Adjunct Professor of Clinic
Study Record Dates
First Submitted
December 13, 2018
First Posted
December 17, 2018
Study Start
November 20, 2018
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
November 22, 2024
Record last verified: 2023-10