Improvement of the Etiological Diagnosis of the Pericarditis

NCT02828085 | Completed

• 2 other identifiers: 2013-302013-A00962-43
• Study Type: interventional
• Target: 979
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of pericarditis whose etiological diagnosis has been established.

  1 day

Secondary Outcomes (2)

• 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

Study Arms (1)

Infective Pericarditis

OTHER

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

Interventions

Nasal swab 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

Infective Pericarditis

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 11, 2016
• Study Start: July 7, 2013
• Primary Completion: July 24, 2019
• Study Completion: October 26, 2022
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

FR (1)