Pericarditis
Conditions
Keywords
PET, pericarditis, FDG
Brief summary
The pericardium is a thin, double-layered sac around the heart that helps reduce friction as the heart moves. When this sac gets inflamed, it is called pericarditis, which can cause serious health problems and even be life-threatening. Pericarditis often comes back after the first episode. About 10-30% of people will have it again, and half of those will have it multiple times. Although there are treatments available, they are costly and not often used because we can't predict who best to use them on. Finding a way to predict which patients would benefit from these treatments could help reduce the burden on patients and the healthcare system. This study will use a test called an 18F-FDG PET/CT with CTA Scan (18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) with computer tomography angiography (CTA)) to measure inflammation in the pericardium. The purpose of the study is to create easy-to-use tools for doctors to identify people at high risk of pericarditis coming back, so they can get advanced treatment early. This study will help fill knowledge gaps about key predictors like clinical signs, blood tests, and imaging results.
Detailed description
This is a single-center, prospective cohort study designed to compare imaging biomarkers identified by CMR and FDG PET between patients who experience recurrent pericarditis and those who do not. In this prospective study, 44 patients will be recruited from the Ottawa Pericardial Clinic, all with a history of recurrent pericarditis. These patients will be followed prospectively for a period of one year. It is hypothesized that patients who develop further episodes of recurrent pericarditis will exhibit significantly elevated markers of pericardial inflammation on both FDG PET/CT imaging as well as CMR imaging.
Interventions
DIAGNOSTIC_TEST18F-FDG PET/CT
The participants will under an 18F-FDG PET/CT with CTA.
Sponsors
Ottawa Heart Institute Research Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Baseline imaging, serum biomaker and clinical factors will be assessed and determined if any of these factors indicate recurrent pericarditis by clinical evaluation of further recurrences of pericarditis.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. History of recurrent pericarditis\* (i.e. presentation of at lease 2nd episode of acute pericarditis). 2. Age \>/= 18 years 3. Given informed consent * standard definitions will be used to define an episode of pericarditis. Pericarditis will be diagnosed by using available published criteria, which includes typical pericardial chest pain, pericardial friction rubs, widespread ST segment elevation or PR-segment depression that was not previously reported and new or worsening pericardial effusion on echocardiography. A clinical diagnosis of acute pericarditis will be made when at least 3 of these criteria are present.
Exclusion criteria
1. severe valve disease requiring intervention 2. claustrophobia that precludes FDG/PET or CMR imaging 3. pregnancy (all women of child bearing potential will have a negative BHCG test) 4. breastfeeding 5. glomerular filtration rate (GFR) \<50 m/min/1.72m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pericardial contrast uptake on late gadolinium enhancement (LGE) on CMR | At Baseline | Pericardial imaging by CMR to evaluate inflammation |
| Circumferential linear increased FDG signal uptake | baseline | Pericardial Imaging to indicate pericardial inflammation. |
| Recurrent pericarditis | From baseline to 1 year | \# of participants that experience pericarditis recurrence after the qualifying occurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Factor - Age | At Baseline | Participant Age |
| Clinical Factor - Sex | At Baseline | Sex of participant |
| Clinical Factor - Family history of auto-immune disease | baseline | Presence of family history of auto-immune disease |
| Clinical Factor - Heart Rate | At Baseline | Resting Heart rate of \>80beats per minute |
| Serum biomarkers - C-Reactive Protein | At Baseline | C-Reactive protein levels |
| Serum biomarkers - Erythrocyte sedimentation rate (ESR) | At Baseline | ESR level |
| Serum biomarkers - carcinoembryonic antigen cell adhesion molecule 1 (CEACAM1) | At Baseline | CEACAM1 levels |
| Serum biomarkers - MHC class I chain related protein A (MICA) | At Baseline | MICA levels |
| Serum biomarkers - MHC Class I chain related protein B (MICB) | At Baseline | MICB levels |
Contacts
CONTACTKevin Boczar, MD
CONTACTPoppy MacPhee, RN
Outcome results
None listed