Improvement of the Etiological Diagnosis of the Pericarditis (PERICARDITE)

Pericardial syndrome includes pericardites acute pericardial effusion and cardiac tamponade, recurrent pericarditis squeezing chronic pericarditis. The etiologies are very numerous and can be classified as infectious, neoplastic, metabolic or systemic, toxic causes. Diagnosis is difficult, and 80% of etiologies remain classified idiopathic. In their laboratory to improve the diagnosis of this syndrome investigators have developed a strategy of systematic prescription of biological tests by kit. This prescription by 'kit' strategy proved its interest by comparison with an intuitive requirement of biological. In this study investigators want to improve the diagnostic causative of pericarditis by implementing a new diagnostic strategy. This new strategy includes (i) samples additional less invasive for the patient, the swab pharyngeal and nasal, (ii) the addition of at the outset of more effective diagnostic techniques: specific Polymerase Chain Reaction (PCR)

Study Overview

• Status: Completed
• Conditions: Infective Pericarditis
• Intervention / Treatment: Biological: Nasal swab

• Study Type: Interventional
• Enrollment (Actual): 979
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient prescribed with a pericarditis kit for etiological diagnosis of a pericardial syndrome.
• Adult patient (= or > 18 years old)
• Patient who freely signed the informed consent form.
• Patient affiliated to a health insurance regime

Exclusion Criteria:

• Minor patient ( age <18 years)
• Pregnant, parturient or breastfeeding woman
• Adult patient incapable or unable to consent
• Patient deprived of liberty under judgment
• Person living in a health or social specialised structure
• Person in vital emergency situation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Infective Pericarditis; In patient prescribed with a pericardite kit for an etiological diagnosis of a pericardial syndrome, an additional nasal swab will be performed in order to perform a specific diagnosis with PCR technique.	Biological: Nasal swab; Nasal swab will be performed in addition to the routine diagnosis visit in order to determine the diagnosis of infective pericardite with a more specific technique: PCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of pericarditis whose etiological diagnosis has been established.	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Identification of the detected emerging pathogens among infectious causesof pericarditis	1 day
Prevalence of the emerging pathogens: assessement of the percentage of emerging pathogens among the studied population	1 day

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2013
• Primary Completion (Actual): July 24, 2019
• Study Completion (Actual): October 26, 2022

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pericarditis
• Other Study ID Numbers: 2013-30; 2013-A00962-43 (Other Identifier: ANSM)