Pulmonary Embolism
Conditions
Brief summary
The purpose of the study COVID-EP is to classify all the complications occurring after the diagnosis of pulmonary embolism in patients tested initially COVID-19 positive and negative by RT-PCR (on nasopharyngeal sample) during the peak of the pandemic in France (April 2020). The patients will be followed for 1 year in order to provide clinical and paraclinical data not yet published in the literature. In order to secondarily confirm the COVID-19 status of initially negative COVID-19 patients (by RT-PCR), a serology test will be performed. The collected complications will then be compared between each of the 3 following groups: \[PCR-COVID 19-Neg & Sero-COVID 19-Neg\] versus \[PCR-COVID 19-Neg & Sero-COVID 19-Pos\] versus \[PCR-COVID 19-Pos\].
Interventions
DIAGNOSTIC_TESTSerology test for COVID-19
In order to secondarily confirm the COVID-19 status of initially negative COVID-19 patients (by RT-PCR), a serology test will be performed in two parts: 1. ELISA test 2. Rapid Diagnostic tests (only if ELISA test is positive)
Sponsors
Hospital St. Joseph, Marseille, France
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥ 18 years, * Diagnosed for pulmonary embolism between April 1st and April 30th, 2020; (treated by ambulatory care or hospitalized), * Having given free and informed written consent, * Being affiliated with or benefiting from a social security scheme.
Exclusion criteria
* Subject to a measure for the protection of justice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % of patients for each group presenting the occurrence of PE complications defined by the occurrence of at least ONE of the following events up to 6 months after PE diagnosis. | 6 months after PE diagnosis | PE complications : * Chronic interstitial pathology, or * Recurrence of PE, or * Pulmonary hypertension, or * Death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % of patients for each group and subgroup presenting the occurrence of PE complications defined by the occurrence of at least ONE of the following events up to 12 months after PE diagnosis. | 12 months after PE diagnosis | PE complications : * Chronic interstitial pathology, or * Recurrence of PE, or * Pulmonary hypertension, or * Death. |
| % of patients in each group presenting the occurrence of each of the following events at each follow-up (3 months, 6 months and 12 months after PE diagnosis). | 3, 6 and 12 months after PE diagnosis | PE complications : * Chronic interstitial pathology, or * Recurrence of PE, or * Pulmonary hypertension, or * Death. |
| % of patients diagnosed COVID - at M0 by RT-PCR on nasopharyngeal swab and diagnosed COVID + by serology 3 months after PE diagnosis | 3 months after PE diagnosis | — |
| Effectiveness of the different category of treatments used in all patients and in the groups: % of occurrence of PE complications for each categories of treatments | 12 months after PE diagnosis | Category of treatments: * Heparin + AVK * Heparin + DOAC PE complication : * Chronic interstitial pathology, or * Recurrence of PE, or * Pulmonary hypertension, or * Death. |
| Effectiveness of the different category of treatments used in all patients and in the groups: % of patients with occurrence of bleeding complications for each categories of treatments | 12 months after PE diagnosis | Category of treatments: * Heparin + AVK * Heparin + DOAC Bleeding complications: classification 1-2-3-5 according to BARC |
| Effectiveness of the different category of treatments used in all patients and in the groups: duration of Heparin treatment (number of day) | 12 months after PE diagnosis | Category of treatments: * Heparin + AVK * Heparin + DOAC |
| Effectiveness of the different category of treatments used in all patients and in the groups: % of patients with no occurrence of complications for each categories of treatments | 12 months after PE diagnosis | Category of treatments: * Heparin + AVK * Heparin + DOAC |
Countries
France
Outcome results
None listed