Pericardial Fluid Analysis in Recurrent Pericarditis

Summary

This clinical trial aims to examine the biochemical and cytological features of pericardial effusion during acute and recurrent pericarditis and to understand the molecular factors responsible for pathogenesis. The primary objective of this study is to identify and validate diagnostic criteria in pericardial fluid analysis that can differentiate patients with acute and recurrent pericarditis from those with only pericardial fluid but no inflammation.

This study will enroll patients with acute pericarditis who require pericardiocentesis for either diagnostic or therapeutic purposes. Two control groups will also be included: one consisting of patients who need cardiac surgery with a collection of pericardial fluid, and the other consisting of patients who require pericardiocentesis for non-inflammatory pericardial effusion. The purpose of the study is to compare the cell activation status and cytokines present in pericardial fluid during acute pericarditis with those present during other pericardial pathologies.

Conditions

• Acute Pericarditis
• Pericardial Effusion
• Pericardial Disease
• Pericardial Fluid Exudate
• Autoinflammatory Disorders
• Autoinflammatory 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.

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco

  lead OTHER

Principal Investigators

• Antonio Luca Brucato, Prof. · ASST Fatebenefratelli Sacco

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-18

Primary Completion

2029-02-28

Completion

2031-02-28

Countries

• Italy

Study Locations