Pericardial Imaging Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pericarditis
• Intervention / Treatment: Diagnostic test: 18F-FDG PET/CT

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Kevin Boczar, MD; Phone Number: 613-696-7083; Email: KBoczar@ottawaheart.ca
• Study Contact Backup: Name: Poppy MacPhee, RN; Email: pmacphee@ottawaheart.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recurrent pericarditis; This is a single arm study. Participants enrolled will complete blood and imaging tests.	Diagnostic test: 18F-FDG PET/CT; The participants will under an 18F-FDG PET/CT with CTA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Factor - Age	Participant Age	At Baseline
Clinical Factor - Sex	Sex of participant	At Baseline
Clinical Factor - Family history of auto-immune disease	Presence of family history of auto-immune disease	baseline
Clinical Factor - Heart Rate	Resting Heart rate of >80beats per minute	At Baseline
Serum biomarkers - C-Reactive Protein	C-Reactive protein levels	At Baseline
Serum biomarkers - Erythrocyte sedimentation rate (ESR)	ESR level	At Baseline
Serum biomarkers - carcinoembryonic antigen cell adhesion molecule 1 (CEACAM1)	CEACAM1 levels	At Baseline
Serum biomarkers - MHC class I chain related protein A (MICA)	MICA levels	At Baseline
Serum biomarkers - MHC Class I chain related protein B (MICB)	MICB levels	At Baseline

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: PET; FDG; pericarditis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Pericarditis
• Other Study ID Numbers: 20250237-01H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No