Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06293924
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-26
Brief Title:
Pericardial Fluid Analysis in Recurrent Pericarditis
Sponsor:
ASST Fatebenefratelli Sacco
Organization:
ASST Fatebenefratelli Sacco
Study Overview
Official Title:
The Pericardial Fluid Analysis in Recurrent Pericarditis Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEFLANA
Brief 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
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
Detailed Description:
Idiopathic recurrent pericarditis is a condition characterized by recurrent inflammation of the pericardial sac and sometimes another serosa accompanied by systemic signs and symptoms Differential diagnosis of this condition includes all forms of pericarditis secondary to other diseases such as infections autoimmune and autoinflammatory diseases malignancy and other conditions post-actinic post-traumatic post-pericardiotomy or post-infarct pericarditis or those associated with metabolic dysregulations such as uremia Some patients have pericardial effusion without any signs of inflammation this condition is known as idiopathic pericardial effusion
The analysis of pericardial effusion helps diagnostic and therapeutic decisions European Society of Cardiology ESC guidelines recommend pericardial fluid analysis from pericardiocentesis or surgical access only whenever a suspected infectious or neoplastic form Pericardiocentesis is also a procedure used to remove excess fluid from the sac surrounding the heart with hemodynamic effects on ventricular diastolic filling It is performed in emergencies such as cardiac tamponade to relieve pressure on the heart
The causes and mechanisms of idiopathic pericarditis are not yet well understood However studies have shown that colchicine a medication used to treat this condition can prevent the formation of microtubules the migration of neutrophils and the formation of the NLRP3 inflammasome These factors have been suggested to play a role in the development of this disease In addition research has focused on the use of Anakinra an anti-interleukin 1 IL-1 drug in the treatment of acute pericarditis This confirms the possible involvement of IL-1 beta in this disease It is produced by the activation of a complex called NLRP3 inflammasome which is triggered by microbial products PAMPs urate crystals cholesterol and molecules known as damage-associated molecular patterns DAMPs Therapeutic options for idiopathic pericarditis include colchicine non-steroidal anti-inflammatory drugs NSAIDs steroids and IL-1 antagonists to regulate inflammation and leukocyte migration
This study focuses on two main unmet needs related to acute and recurrent pericarditis The first need is related to the informativeness of the data obtained through pericardiocentesis Although the biochemical analysis is recommended by ESC guidelines the most valuable data in the diagnostic process comes from cytological and microbiological analyses These analyses help in excluding neoplastic or infectious etiologies Biochemical features of pericardial fluid are less understood than those of peritoneal and pleural fluids Specific biochemical parameters used to distinguish exudation as Lights criteria do not apply to pericardial fluid a previous study showed a unique composition of pericardial fluid which suggests that Lights criteria cannot be used in this case The second unsatisfied need is related to pathogenesis including the pathway of Interleukin-1 IL-1 at the level of pericardial fluid and which cells are responsible for local cytokines and inflammatory mediators productions
This study aims to collect observational data on pericardial effusion analysis and to analyse cellular and molecular composition in a subgroup of patients to assess the pathophysiological mechanisms of disease
The analysis of pericardial effusion helps diagnostic and therapeutic decisions European Society of Cardiology ESC guidelines recommend pericardial fluid analysis from pericardiocentesis or surgical access only whenever a suspected infectious or neoplastic form Pericardiocentesis is also a procedure used to remove excess fluid from the sac surrounding the heart with hemodynamic effects on ventricular diastolic filling It is performed in emergencies such as cardiac tamponade to relieve pressure on the heart
The causes and mechanisms of idiopathic pericarditis are not yet well understood However studies have shown that colchicine a medication used to treat this condition can prevent the formation of microtubules the migration of neutrophils and the formation of the NLRP3 inflammasome These factors have been suggested to play a role in the development of this disease In addition research has focused on the use of Anakinra an anti-interleukin 1 IL-1 drug in the treatment of acute pericarditis This confirms the possible involvement of IL-1 beta in this disease It is produced by the activation of a complex called NLRP3 inflammasome which is triggered by microbial products PAMPs urate crystals cholesterol and molecules known as damage-associated molecular patterns DAMPs Therapeutic options for idiopathic pericarditis include colchicine non-steroidal anti-inflammatory drugs NSAIDs steroids and IL-1 antagonists to regulate inflammation and leukocyte migration
This study focuses on two main unmet needs related to acute and recurrent pericarditis The first need is related to the informativeness of the data obtained through pericardiocentesis Although the biochemical analysis is recommended by ESC guidelines the most valuable data in the diagnostic process comes from cytological and microbiological analyses These analyses help in excluding neoplastic or infectious etiologies Biochemical features of pericardial fluid are less understood than those of peritoneal and pleural fluids Specific biochemical parameters used to distinguish exudation as Lights criteria do not apply to pericardial fluid a previous study showed a unique composition of pericardial fluid which suggests that Lights criteria cannot be used in this case The second unsatisfied need is related to pathogenesis including the pathway of Interleukin-1 IL-1 at the level of pericardial fluid and which cells are responsible for local cytokines and inflammatory mediators productions
This study aims to collect observational data on pericardial effusion analysis and to analyse cellular and molecular composition in a subgroup of patients to assess the pathophysiological mechanisms of disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None