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CompletedNCT02828085PERICARDITEUpdated Apr 21, 2023

Improvement of the Etiological Diagnosis of the Pericarditis

An interventional study of Nasal swab in Infective Pericarditis, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-21.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Jul 2013, registered Jun 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
979
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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)

02

Conditions studied

  • Infective Pericarditis

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03

In context

Pericarditis

54 studies on the registry are indexed under Pericarditis; 23 are open to participants now.

This study's enrollment of 979 is above the median of 60 across 29 interventional studies indexed under Pericarditis.

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Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.
  • Patient affiliated to a health insurance regime

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
979 participants (actual)

Study arms

  • 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

Interventions

  • BiologicalNasal 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

06

What researchers measure

Primary outcomes

  1. Percentage of pericarditis whose etiological diagnosis has been established.

    Time frame: 1 day

Secondary outcomes

  1. Identification of the detected emerging pathogens among infectious causesof pericarditis

    Time frame: 1 day

  2. Prevalence of the emerging pathogens: assessement of the percentage of emerging pathogens among the studied population

    Time frame: 1 day

07

Study locations

1 site
  • Assistance Publique Hopitaux de Marseille
    Marseille, 13354, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02828085
Responsible party
Sponsor
First posted
Jul 11, 2016
Start date
Jul 7, 2013
Primary completion
Jul 24, 2019
Completion
Oct 26, 2022
Last update
Apr 21, 2023
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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