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RecruitingNCT07245849Updated Nov 3, 2026

Pericardial Imaging Study

A Phase 3 interventional study of 18F-FDG PET/CT in Pericarditis, sponsored by Ottawa Heart Institute Research Corporation. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Ottawa Heart Institute Research Corporation · Phase 3, Interventional, and Diagnostic

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Updated Nov 3, 2026Now RecruitingFirst site in Canada+3 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pericarditis

Browse trials for

Keywords

  • PET
  • pericarditis
  • FDG
03

In context

Pericarditis

54 studies on the registry are indexed under Pericarditis; 23 are open to participants now.

This study's planned enrollment of 44 is below the median of 60 across 29 interventional studies indexed under Pericarditis.

Browse Pericarditis studies →

Lead sponsor

Ottawa Heart Institute Research Corporation is the lead sponsor of 182 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. History of recurrent pericarditis* (i.e. presentation of at lease 2nd episode of acute pericarditis).
  2. Age >/= 18 years
  3. Given

    • 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

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. (GFR) \<50 m/min/1.72m2
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Recurrent pericarditis

    This is a single arm study. Participants enrolled will complete blood and imaging tests.

    Diagnostic Test: 18F-FDG PET/CT

Interventions

  • Diagnostic test18F-FDG PET/CT

    The participants will under an 18F-FDG PET/CT with CTA.

06

What researchers measure

Primary outcomes

  1. Pericardial contrast uptake on late gadolinium enhancement (LGE) on CMR

    Pericardial imaging by CMR to evaluate inflammation

    Time frame: At Baseline

  2. Circumferential linear increased FDG signal uptake

    Pericardial Imaging to indicate pericardial inflammation.

    Time frame: baseline

  3. Recurrent pericarditis

    \# of participants that experience pericarditis recurrence after the qualifying occurrence

    Time frame: From baseline to 1 year

Secondary outcomes

  1. Clinical Factor - Age

    Participant Age

    Time frame: At Baseline

  2. Clinical Factor - Sex

    Sex of participant

    Time frame: At Baseline

  3. Clinical Factor - Family history of auto-immune disease

    Presence of family history of auto-immune disease

    Time frame: baseline

  4. Clinical Factor - Heart Rate

    Resting Heart rate of \>80beats per minute

    Time frame: At Baseline

  5. Serum biomarkers - C-Reactive Protein

    C-Reactive protein levels

    Time frame: At Baseline

  6. Serum biomarkers - Erythrocyte sedimentation rate (ESR)

    ESR level

    Time frame: At Baseline

  7. Serum biomarkers - carcinoembryonic antigen cell adhesion molecule 1 (CEACAM1)

    CEACAM1 levels

    Time frame: At Baseline

  8. Serum biomarkers - MHC class I chain related protein A (MICA)

    MICA levels

    Time frame: At Baseline

  9. Serum biomarkers - MHC Class I chain related protein B (MICB)

    MICB levels

    Time frame: At Baseline

07

Study locations

1 of 1 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 3, 2026
Sites
1 site added — first site in Canada
Show site
  • University of Ottawa Heart Institute · Ottawa, Canada
Nov 3, 2026
Start date
Dec 2026→Jun 17, 2026 (actual)
Nov 3, 2026
Contact
Study contact changed: p•••@ottawaheart.ca→p•••@ottawaheart.ca. See the current contact
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in Canada
    Show site
    • University of Ottawa Heart Institute · Ottawa, Canada
    Start date Dec 2026→Jun 17, 2026 (now actual)
    Contact Study contact changed: p•••@ottawaheart.ca→p•••@ottawaheart.ca. See the current contact
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07245849
Responsible party
Sponsor
First posted
Nov 24, 2025
Start date
Jun 17, 2026
Primary completion
Feb 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Kevin Boczar, MD
Contact
KBoczar@ottawaheart.ca
613-696-7083
Ashley Cowan, RN
Contact
pmacphee@ottawaheart.ca

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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