44 Participants NeededMy employer runs this trial

18F-FDG PET/CT Imaging for Pericarditis

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PM
AC
Overseen ByAshley Cowan, RN
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Ottawa Heart Institute Research Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This study is for adults (18 or older) who have had at least two episodes of pericarditis, diagnosed by standard criteria. Participants must be able to give informed consent.

Inclusion Criteria

Given informed consent
I am 18 years old or older.
I have had at least two episodes of acute pericarditis with typical symptoms and signs.

Exclusion Criteria

I have severe heart valve disease that needs treatment.
Breastfeeding
Glomerular filtration rate (GFR) less than 50 mL/min/1.72m2
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What Are the Treatments Tested in This Trial?

Trial Overview

The trial uses an imaging test called 18F-FDG PET/CT with CTA to measure inflammation around the heart in people with recurrent pericarditis. The goal is to find ways to predict who might have future flare-ups.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Recurrent pericarditisExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials
200
Recruited
95,800+