AzTrials
AzTrials

PericarditisPhase 3NCT07245849

Pericardial Imaging Study

A Phase 3 study testing 18F-FDG PET/CT in people with Pericarditis, run by Ottawa Heart Institute Research Corporation.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pericarditis
What is being tested?
18F-FDG PET/CT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
No sites listed yet
Study dates
Dec 2026to Jul 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Kevin Boczar, MD contact

613-696-7083

KBoczar@ottawaheart.ca

Poppy MacPhee, RN contact

pmacphee@ottawaheart.ca

About this study

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

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.

Conditions
Pericarditis
Being tested
18F-FDG PET/CT
Keywords
PET, pericarditis, FDG
Medical subject headings
Pericarditis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-FDG PET/CTDiagnostic test

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

Study groups in NCT07245849
Study groupRoleWhat they receive
Recurrent pericarditisExperimentalThis is a single arm study. Participants enrolled will complete blood and imaging tests.
Receives: Diagnostic Test: 18F-FDG PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Pericardial imaging by CMR to evaluate inflammation

    Measured: At Baseline

  2. Circumferential linear increased FDG signal uptake

    Pericardial Imaging to indicate pericardial inflammation.

    Measured: baseline

  3. Recurrent pericarditis

    # of participants that experience pericarditis recurrence after the qualifying occurrence

    Measured: From baseline to 1 year

Secondary outcomes (9)

  1. Clinical Factor - Age

    Participant Age

    Measured: At Baseline

  2. Clinical Factor - Sex

    Sex of participant

    Measured: At Baseline

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

    Presence of family history of auto-immune disease

    Measured: baseline

  4. Clinical Factor - Heart Rate

    Resting Heart rate of >80beats per minute

    Measured: At Baseline

  5. Serum biomarkers - C-Reactive Protein

    C-Reactive protein levels

    Measured: At Baseline

  6. Serum biomarkers - Erythrocyte sedimentation rate (ESR)

    ESR level

    Measured: At Baseline

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

    CEACAM1 levels

    Measured: At Baseline

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

    MICA levels

    Measured: At Baseline

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

    MICB levels

    Measured: At Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2025
  2. Study startDec 2026 (estimated)
  3. Primary completionFeb 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07245849
Sponsor's protocol ID
20250237-01H
Status last verified
Oct 2025
First submitted
17 Nov 2025
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 18F-FDG PET/CT in people with Pericarditis, run by Ottawa Heart Institute Research Corporation.

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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kevin Boczar, MD (613-696-7083, KBoczar@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pericardial contrast uptake on late gadolinium enhancement (LGE) on CMR (time frame: At Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07245849.

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 1 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in