Improvement of the Etiological Diagnosis of the Pericarditis

Infective Pericarditis Clinical Trial

— PERICARDITE  

Official title:

Improvement of the Etiological Diagnosis of the Pericarditis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828085
• Other study ID #: 2013-30
• Secondary ID: 2013-A00962-43
• Status: Completed
• Phase: N/A
• Start date: July 7, 2013
• Est. completion date: October 26, 2022

Study information

• Verified date: April 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 979
• Est. completion date: October 26, 2022
• Est. primary completion date: July 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infective Pericarditis
• Pericarditis

Intervention

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

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of pericarditis whose etiological diagnosis has been established.		1 day
Secondary	Identification of the detected emerging pathogens among infectious causesof pericarditis		1 day
Secondary	Prevalence of the emerging pathogens: assessement of the percentage of emerging pathogens among the studied population		1 day