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NCT Number: NCT07245849

Pericardial Imaging Study

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.

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Key information

Conditions

Pericarditis Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • severe valve disease requiring intervention
  • claustrophobia that precludes FDG/PET or CMR imaging
  • pregnancy (all women of child bearing potential will have a negative BHCG test)
  • breastfeeding
  • glomerular filtration rate (GFR) <50 m/min/1.72m2

Treatment and study plan

18F-FDG PET/CT

Diagnostic Test

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

Primary outcomes

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

    Time frame: At Baseline

    Pericardial imaging by CMR to evaluate inflammation

  2. Circumferential linear increased FDG signal uptake

    Time frame: baseline

    Pericardial Imaging to indicate pericardial inflammation.

  3. Recurrent pericarditis

    Time frame: From baseline to 1 year

    # of participants that experience pericarditis recurrence after the qualifying occurrence

Secondary outcomes

  1. Clinical Factor - Age

    Time frame: At Baseline

    Participant Age

  2. Clinical Factor - Sex

    Time frame: At Baseline

    Sex of participant

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

    Time frame: baseline

    Presence of family history of auto-immune disease

  4. Clinical Factor - Heart Rate

    Time frame: At Baseline

    Resting Heart rate of >80beats per minute

  5. Serum biomarkers - C-Reactive Protein

    Time frame: At Baseline

    C-Reactive protein levels

  6. Serum biomarkers - Erythrocyte sedimentation rate (ESR)

    Time frame: At Baseline

    ESR level

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

    Time frame: At Baseline

    CEACAM1 levels

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

    Time frame: At Baseline

    MICA levels

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

    Time frame: At Baseline

    MICB levels

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin Boczar, MD

CONTACT

[email protected]

613-696-7083

Poppy MacPhee, RN

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

Identifying Clinical, Serum, and Imaging Based Biomarkers Associated With High-Risk Phenotypes for Recurrent Pericarditis: A Prospective Cohort Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 24, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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