Improvement of the Etiological Diagnosis of the Pericarditis

NCT ID: NCT02828085

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 979 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-07
• Study Completion Date: 2022-10-26

Brief Summary

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)

Conditions

Infective Pericarditis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Nasal swab

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2013-A00962-43

Identifier Type: OTHER

Identifier Source: secondary_id

2013-30

Identifier Type: -

Identifier Source: org_study_id