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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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [PCR-COVID 19-Pos] group | Having a microbiological diagnosis confirming COVID-19 infection (ie positive RT-PCR on nasopharyngeal swab) and/or clinical/CT signs | ||
| [PCR-COVID 19-Neg] group | Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs |
| |
| [PCR-COVID 19-Neg & Sero-COVID 19-Pos] group |
| ||
| [PCR-COVID 19-Neg & Sero-COVID 19-Neg] group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serology test for COVID-19 | Diagnostic Test | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| % 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. | PE complications :
| 6 months after PE diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| % 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. | PE complications :
| 12 months after PE diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
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Patient diagnosed and / or hospitalized for PE in April 2020 (the COVID-19 pandemic peak)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint Joseph Marseille | Marseille | France |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D012698 | Serologic Tests |
| ID | Term |
|---|---|
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| % 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). |
PE complications :
|
| 3, 6 and 12 months after PE diagnosis |
| % 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 | Category of treatments:
PE complication :
| 12 months after PE diagnosis |
| 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 | Category of treatments:
Bleeding complications: classification 1-2-3-5 according to BARC | 12 months after PE diagnosis |
| 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 | Category of treatments:
| 12 months after PE diagnosis |
| Effectiveness of the different category of treatments used in all patients and in the groups: duration of Heparin treatment (number of day) | Category of treatments:
| 12 months after PE diagnosis |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |