Clinical Trial

Pericardial Fluid Analysis in Recurrent Pericarditis

Study acronym: PEFLANA
Enrolling by Invitation
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-03-02.
Status change: Not Yet Recruiting → Enrolling by Invitation 2024-11-25
Trial Details
NCT Number NCT06293924
Lead Sponsor ASST Fatebenefratelli Sacco
Conditions Acute Pericarditis, Pericardial Effusion, Pericardial Disease, Pericardial Fluid Exudate, Autoinflammatory Disorders, Autoinflammatory Disease
Enrollment 432 participants
Start Date 2024-08-18
Primary Completion 2029-02 (estimated)
Study Completion 2031-02 (estimated)
Updated on ClinicalTrials.gov 2024-11-27