Pericardial Imaging Study

NCT07245849 | Not Yet Recruiting Phase 3

• 1 other identifier: 20250237-01H
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pericarditis

Keywords

PET; pericarditis; FDG

Outcome Measures

Primary Outcomes (3)

• Pericardial contrast uptake on late gadolinium enhancement (LGE) on CMR

  Pericardial imaging by CMR to evaluate inflammation

  At Baseline

• Circumferential linear increased FDG signal uptake

  Pericardial Imaging to indicate pericardial inflammation.

  baseline

• Recurrent pericarditis

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

  From baseline to 1 year

Secondary Outcomes (9)

• Clinical Factor - Age

  At Baseline

• Clinical Factor - Sex

  At Baseline

• Clinical Factor - Family history of auto-immune disease

  baseline

• Clinical Factor - Heart Rate

  At Baseline

• Serum biomarkers - C-Reactive Protein

  At Baseline

Study Arms (1)

Recurrent pericarditis

EXPERIMENTAL

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

Diagnostic Test: 18F-FDG PET/CT

Interventions

18F-FDG PET/CT DIAGNOSTIC_TEST

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

Recurrent pericarditis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

MeSH Terms

Conditions

Pericarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Kevin Boczar, MD

CONTACT

613-696-7083; KBoczar@ottawaheart.ca

Poppy MacPhee, RN

CONTACT

pmacphee@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2025-10