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Pericardial Imaging Study

NCT ID: NCT07245849

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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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

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Pericarditis

Keywords

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PET pericarditis FDG

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Recurrent pericarditis

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

Group Type EXPERIMENTAL

18F-FDG PET/CT

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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18F-FDG PET/CT

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Kevin Boczar, MD

Role: CONTACT

Phone: 613-696-7083

Email: [email protected]

Poppy MacPhee, RN

Role: CONTACT

Email: [email protected]

Other Identifiers

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20250237-01H

Identifier Type: -

Identifier Source: org_study_id