Pericardial Fluid Analysis in Recurrent Pericarditis

Enrolling by invitationOBSERVATIONAL
Enrollment

432

Participants

Timeline

Start Date

August 18, 2024

Primary Completion Date

February 28, 2029

Study Completion Date

February 28, 2031

Conditions
Acute PericarditisPericardial EffusionPericardial DiseasePericardial Fluid ExudateAutoinflammatory DisordersAutoinflammatory Disease
Interventions
DIAGNOSTIC_TEST

Pericardiocentesis

"Enrolled patients will not undergo any invasive investigations outside of normal clinical practice. Patients with acute pericarditis and non-inflammatory pericardial effusion will undergo pericardiocentesis for diagnostic or therapeutic purposes.~Four ml of pericardial fluid will be collected: 2 ml for biochemical analysis in lithium heparin or serum-gel separator-associated tubes, and 2 ml for cellular analysis in K3 EDTA tubes."

DIAGNOSTIC_TEST

Pericardiotomy

"During any type of cardiac surgery involving pericardiotomy, 4 ml of pericardial fluid will be collected and analyzed upon opening the pericardial sac of enrolled patients.~Four ml of pericardial fluid will be collected: 2 ml for biochemical analysis in lithium heparin or serum-gel separator-associated tubes, and 2 ml for cellular analysis in K3 EDTA tubes."

DIAGNOSTIC_TEST

Cytofluorometry and Gene expression analysis

"A 30 ml sample of peripheral venous blood in K3 EDTA tubes will be collected by enrolled patients who participating in the translational substudy and stored with pericardial fluid samples.~Pericardial fluid cells by lineage and expression of inflammatory cytokines will be characterized through cytofluorometry and expression profile analysis of transcribed RNAs. Cytokine concentrations in peripheral blood and pericardial fluid will be analyzed by molecular assay. Peripheral blood mononucleated cells (PBMCs) and pericardial fluid cells will be cultured in vitro and exposed to the main therapies used during pericarditis, to verify the effects on gene expression and inflammatory molecules."

Trial Locations (1)

20122

ASST FAtebenefratelli Sacco, Milan

All Listed Sponsors
lead

ASST Fatebenefratelli Sacco

OTHER

NCT06293924 - Pericardial Fluid Analysis in Recurrent Pericarditis | Biotech Hunter | Biotech Hunter