IL-1RA Antibodies in Myocarditis after SARS-CoV-2 Vaccination.
Lorenz Thurner, Christoph Kessel, Natalie Fadle...
https://pubmed.ncbi.nlm.nih.gov/36130012Actively Recruiting
Led by ASST Fatebenefratelli Sacco · Updated on 2024-07-03
146
Participants Needed
9
Research Sites
24 weeks
Total Duration
A
ASST Fatebenefratelli Sacco
Lead Sponsor
F
Fatebenefratelli Hospital
Collaborating Sponsor
Researchers are investigating recurrent pericarditis (RP), a condition that affects the heart's lining and can cause repeated episodes of inflammation. This study aims to explore the underlying causes of RP by testing for specific antibodies against the interleukin-1 receptor antagonist (IL-1RA) and measuring levels of soluble urokinase plasminogen activator receptor (suPAR). These tests may help distinguish between inflammatory and non-inflammatory forms of RP and improve understanding of how the disease works. The study also examines the relationship between these markers and signs of heart damage and inflammation, with the goal of guiding treatment decisions involving anakinra, a medication that blocks IL-1 pathways. Participants will be assessed based on whether they show signs of inflammation during RP episodes, such as fever or elevated blood markers, or if they have a non-inflammatory form without these signs. The study uses blood tests to measure IL-1RA antibodies and suPAR levels through established laboratory methods. Testing will occur during acute flare-ups and periods between episodes when possible, to track changes over time. Patients continue their usual care without changes influenced by the study. Throughout the study, participants will provide blood samples and undergo clinical evaluations to measure markers of inflammation and heart health. Researchers will track how antibody and suPAR levels relate to disease activity and recurrence over 24 months. The study is observational, focusing on collecting detailed biological and clinical data to better characterize RP subtypes and improve future treatment approaches. Safety and ongoing medical care are maintained throughout the study period.
CONDITIONS
Clinical Phenotypes in Pericarditis: IL-1RA Antibodies and suPAR Levels
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 months
Participants undergo blood tests to measure IL-1RA antibodies and suPAR levels to help understand different pericarditis phenotypes.
Longitudinal blood sampling during acute episodes and intercritical phases when feasible
Duration - 24 months
Participants are monitored over time to assess correlations between antibody and suPAR levels with disease activity and recurrence.
Periodic evaluations depending on clinical course
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
M
Maddalena A Wu
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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