Pericardial Effusion Clinical Trial
— PEFLANAOfficial title:
The Pericardial Fluid Analysis in Recurrent Pericarditis Trial
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.
Status | Not yet recruiting |
Enrollment | 432 |
Est. completion date | February 2031 |
Est. primary completion date | February 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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ASST Fatebenefratelli Sacco |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Difference of IL-1 expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion | A flow cytometry analysis is performed to assess absolute and relative cell counts expressing IL-1 in pericardial fluid for the differentiation between pericarditis and non-inflammatory pericardial fluid. | 48 months from patient's enrollment | |
Secondary | Differences of inflammatory cytokine expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion | A flow cytometry analysis is performed to assess absolute and relative cell counts expressing inflammatory cytokines in pericardial fluid for the differentiation between pericarditis and non-inflammatory pericardial fluid. | 48 months from patient's enrollment | |
Secondary | Differences of gene expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion | A gene expression analysis using transcribed RNA assesses absolute and relative cell counts expressing inflammatory cytokines in pericardial fluid and blood samples for the differentiation between pericarditis and non-inflammatory pericardial fluid. | 48 months from patient's enrollment | |
Secondary | Differences of gene expression in pericardial fluid and blood cells during pericarditis | A gene expression analysis evaluates the increase of activated inflammatory cells in pericarditis through absolute and relative cell counts in pericardial fluid and blood samples using transcribed RNA. This analysis can confirm the correlation between activated inflammatory cells in pericardial and blood samples during pericarditis. | 48 months from patient's enrollment | |
Secondary | Differences in cytokine and other molecule concentrations between pericardial fluid and blood cells in pericarditis | Biochemical analysis evaluates the increase of inflammatory cytokines and other molecules in pericarditis in pericardial fluid and blood samples using normal methods of analysis. This analysis can confirm the correlation between inflammatory mediators in pericardial and blood samples during pericarditis. | 48 months from patient's enrollment | |
Secondary | Correlation of inflammatory mediators in pericardial fluid and clinical features during pericarditis | Biochemical analysis evaluates the increase of inflammatory cytokines and other molecules in pericarditis in pericardial fluid and blood samples. This analysis can confirm the correlation between cytokines and other molecules and clinical manifestations during pericarditis. | 48 months from patient's enrollment |
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