protocolSection identificationModule nctId: NCT06293924, orgStudyIdInfo id: The PEFLANA Trial, briefTitle: Pericardial Fluid Analysis in Recurrent Pericarditis, acronym: PEFLANA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2029-02, completionDateStruct date: 2031-02, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: ASST Fatebenefratelli Sacco, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Acute Pericarditis, conditions: Pericardial Effusion, conditions: Pericardial Disease, conditions: Pericardial Fluid Exudate, conditions: Autoinflammatory Disorders, conditions: Autoinflammatory Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 432, type: ESTIMATED, armsInterventionsModule interventions name: Pericardiocentesis, interventions name: Pericardiotomy, interventions name: Cytofluorometry and Gene expression analysis, outcomesModule primaryOutcomes measure: Differences in cell counts among inflammatory and non-inflammatory pericardial effusion., primaryOutcomes measure: Difference in biochemical parameters among inflammatory and non-inflammatory pericardial effusion, secondaryOutcomes measure: Difference of IL-1 expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion, secondaryOutcomes measure: Differences of inflammatory cytokine expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion, secondaryOutcomes measure: Differences of gene expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion, secondaryOutcomes measure: Differences of gene expression in pericardial fluid and blood cells during pericarditis, secondaryOutcomes measure: Differences in cytokine and other molecule concentrations between pericardial fluid and blood cells in pericarditis, secondaryOutcomes measure: Correlation of inflammatory mediators in pericardial fluid and clinical features during pericarditis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False