Actively Recruiting
Clinical Phenotypes in Pericarditis: IL-1RA Antibodies and suPAR Levels
Led by ASST Fatebenefratelli Sacco · Updated on 2024-07-03
146
Participants Needed
9
Research Sites
129 weeks
Total Duration
On this page
Sponsors
A
ASST Fatebenefratelli Sacco
Lead Sponsor
F
Fatebenefratelli Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aims to investigate the pathophysiology of recurrent pericarditis (RP) by testing for neutralizing autoantibodies against interleukin-1 receptor antagonist (IL-1RA) and measuring soluble urokinase plasminogen activator receptor (suPAR) levels. The hypothesis is that these tests will provide insights into both the inflammatory and non-inflammatory phenotypes of RP, shedding light on the underlying mechanisms. The study will assess the correlation between antibody levels, suPAR levels, and markers of cardiac damage and inflammation. Longitudinal testing during acute episodes and intercritical phases is also planned. The results may guide the use of anakinra, an IL-1 receptor antagonist, in specific clinical scenarios and optimize treatment strategies for RP.
CONDITIONS
Official Title
Clinical Phenotypes in Pericarditis: IL-1RA Antibodies and suPAR Levels
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent from patients aged 18 years or older before any evaluation is performed.
- Written informed consent from parents or legal guardians and assent from minors under 18 years before any evaluation is performed.
- Diagnosis of recurrent acute pericarditis during the acute phase, based on at least two of the following: typical pericarditic chest pain, pericardial friction rub, diffuse ST segment elevation or PR depressions, and pericardial effusion.
- New or worsening post-cardiac injury pericarditis diagnosed by the same criteria.
- Known previous CRP values to distinguish inflammatory forms (elevated CRP) from non-inflammatory forms (normal or near-normal CRP).
- Acute phase defined by CRP at least double the normal value for elevated forms or clinical judgment for normal CRP forms.
You will not qualify if you...
- Pericarditis caused by specific etiologies such as tuberculosis, neoplastic or purulent causes, post-cardiac injury syndromes, and autoimmune rheumatic diseases.
- Individuals under 18 years of age.
- Pregnant or lactating women.
- History of immunosuppression, including positive HIV tests.
- Positive tuberculosis tests (QuantiFERON or PPD).
- Other significant medical conditions that could affect study results, such as systemic diseases causing chronic inflammation.
- Use of medications that could alter test results, except those used for pericarditis treatment.
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Trial Site Locations
Total: 9 locations
1
Saarland University
Homburg, Germany
Actively Recruiting
2
University Children's Hospital Muenster
Münster, Germany
Not Yet Recruiting
3
University Hospital Tübingen
Tübingen, Germany
Not Yet Recruiting
4
A.O.U. Careggi
Florence, Italy
Not Yet Recruiting
5
Luigi Sacco Hospital - ASST Fatebenefratelli Sacco
Milan, Italy, 20157
Actively Recruiting
6
Fatebenefratelli Hospital - ASST Fatebenefratelli Sacco
Milan, Italy
Actively Recruiting
7
Ospedale Galeazzi Sant'Ambrogio - IRCCS, Poliambulatorio Cardiovascolare Cardiologia Universitaria
Milan, Italy
Not Yet Recruiting
8
Policlinico di Milano Ospedale Maggiore, Fondazione IRCCS Ca' Granda
Milan, Italy
Not Yet Recruiting
9
Ospedale Santa Maria della Misericordia dell'ASU-FC
Udine, Italy
Not Yet Recruiting
Research Team
M
Maddalena A Wu
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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