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Pericardial Fluid Analysis in Recurrent Pericarditis

Study acronym: PEFLANA
StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Mar 2024 to Aug 18, 2024
    • Study sites: 0 to 1
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06293924
Lead Sponsor ASST Fatebenefratelli Sacco
Conditions
(from sponsor)
Acute Pericarditis, Pericardial Effusion, Pericardial Disease, Pericardial Fluid Exudate, Autoinflammatory Disorders, Autoinflammatory Disease
Related terms Pericardial Effusion, Pericarditis
Enrollment 432 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov