Pericardial Fluid Analysis in Recurrent Pericarditis

NCT06293924 | Enrolling By Invitation

• 1 other identifier: The PEFLANA Trial
• Study Type: observational
• Target: 432
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pericarditis; Pericardial Effusion; Pericardial Disease; Pericardial Fluid Exudate; Autoinflammatory Disorders; Autoinflammatory Disease

Keywords

Acute Pericarditis; Recurrent Pericarditis; Pericardial Effusion; Pericardiocentesis; Cardiac surgery; Cytofluorometry; Gene expression analysis; Autoinflammatory Disorders

Outcome Measures

Primary Outcomes (2)

• Differences in cell counts among inflammatory and non-inflammatory pericardial effusion.

  Both automated cytometry and manual counting were used to obtain absolute and relative cell counts from peripheral blood samples and pericardial fluids. It can help identify and establish diagnostic criteria for distinguishing between patients with acute or recurrent pericarditis and those with non-inflammatory pericardial fluid.

  48 months from patient's enrollment

• Difference in biochemical parameters among inflammatory and non-inflammatory pericardial effusion

  This analysis evaluates the differences in pericardial fluid and peripheral blood among biochemical parameters (total proteins and albumin, lactate dehydrogenase, blood glucose, and cholesterol concentrations). It can help distinguish between patients with acute or recurrent pericarditis and those with non-inflammatory pericardial fluid, thereby aiding in the validation of diagnostic criteria.

  48 months from patient's enrollment

Secondary Outcomes (6)

• Difference of IL-1 expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion

  48 months from patient's enrollment

• Differences of inflammatory cytokine expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion

  48 months from patient's enrollment

• Differences of gene expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion

  48 months from patient's enrollment

• Differences of gene expression in pericardial fluid and blood cells during pericarditis

  48 months from patient's enrollment

• Differences in cytokine and other molecule concentrations between pericardial fluid and blood cells in pericarditis

  48 months from patient's enrollment

Study Arms (3)

Pericarditis patients

Patients with acute idiopathic or post-cardiac injury pericarditis who require diagnostic or therapeutic pericardiocentesis. Four ml of pericardial fluid should be collected: 2 ml for biochemical analysis in lithium heparin or serum-gel separator-associated tubes, and 2 ml for cellular analysis in K3 ethylenediaminetetraacetic acid (K3-EDTA) tubes.

Diagnostic Test: Pericardiocentesis; Diagnostic Test: Cytofluorometry and Gene expression analysis

Pericardial effusion patients without inflammation

Subjects with non-inflammatory pericardial effusion who require diagnostic or therapeutic pericardiocentesis. Four ml of pericardial fluid should 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: Pericardiocentesis; Diagnostic Test: Cytofluorometry and Gene expression analysis

Cardiac surgery pericardial effusion

Patients who undergo cardiac surgery that involves a pericardiotomy. During cardiac surgery, 4 ml of pericardial fluid is collected and analyzed upon opening the pericardial sac. Four ml of pericardial fluid should 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; Diagnostic Test: Cytofluorometry and Gene expression analysis

Interventions

Pericardiocentesis DIAGNOSTIC_TEST

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.

Pericardial effusion patients without inflammation; Pericarditis patients

Pericardiotomy DIAGNOSTIC_TEST

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.

Cardiac surgery pericardial effusion

Cytofluorometry and Gene expression analysis DIAGNOSTIC_TEST

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.

Cardiac surgery pericardial effusion; Pericardial effusion patients without inflammation; Pericarditis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For the first two arms, patients from the primary care clinic (Emergency room department). For the third arm, patients who need to undergo cardiac surgery with pericardial sac involvement.

You may qualify if:

• Patients with acute idiopathic or post-cardiac injury pericarditis who require diagnostic or therapeutic pericardiocentesis (Interventional arm)
• Subjects with non-inflammatory pericardial effusion who require diagnostic or therapeutic pericardiocentesis (First control arm)
• Patients who undergo cardiac surgery that involves a pericardiotomy (Second control arm)

You may not qualify if:

• Pregnancy or breastfeeding
• Ongoing infections, including active viral hepatitis or Coronavirus Disease 19 (COVID-19) positivity in the previous 21 days
• Systemic inflammatory disorders not attributable to pericarditis, excluding inflammatory diseases in remission
• Solid or haematological malignancies, ongoing or less than 6 months disease-free interval or anti-blastic chemotherapy (excluding the hormone therapy)
• Immunosuppressive therapy for reasons other than pericarditis treatment.
• Moderate-severe kidney failure (GFR \< 30 ml/min)
• Moderate-severe liver failure (Child-Pug B or C), active hepatitis
• Diabetes mellitus
• Severe hypoproteinemia/malnutrition

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead

Study Sites (1)

ASST FAtebenefratelli Sacco

Milan, Lombardy, 20122, Italy

Location

MeSH Terms

Conditions

Pericardial Effusion; Pericarditis

Interventions

Pericardiocentesis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures; Investigative Techniques

Study Officials

• Antonio Luca Brucato, Prof.

  ASST Fatebenefratelli Sacco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 48 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 5, 2024
• Study Start: August 18, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2031
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)