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Incidence of Acute Pulmonary Embolism in Covid-19 Patients on CT Angiography and Relationship to D-dimer Levels (COVID-APE)

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ClinicalTrials.gov Identifier: NCT04373486
Recruitment Status : Completed
First Posted : May 4, 2020
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:

Reports of acute pulmonary embolism (APE) associated with COVID-19 have emerged in the literature. For example, Chen et al. described 25 pulmonary CT angiograms examinations from 1008 COVID-19 patients; 10 were positive for pulmonary embolism mostly as segmental or sub-segmental APE. Case reports of APE in Covid-19 patients have been published. Cui et al. found an incidence of deep venous thrombosis in intensive care unit (ICU) patients with severe Covid-19 pneumonia near to 25% (20/81), however without any correlation with potential APE.

Despite these initial reports, it is not clear whether APE is more frequent in Covid-19 patients or if the association is just random. In favor of the former, D-dimer levels have been reported as elevated in patients with Covid-19 by two studies, and it has been suggested an independent association between the severity of the disease and the level of D-dimer. Finally, Tang et al. showed that anticoagulant therapy is associated with a decreased mortality at Day-28 in severe Covid-19 patients, in favor of a possible associated coagulopathy. The purpose of this study is to describe the rate of pulmonary embolus in patients classified as COVID-19 infection and who underwent chest CT angiography.

The purpose of this study is to describe the rate of pulmonary embolus in patients classified as COVID-19 infection and who underwent chest CT angiography.


Condition or disease
Covid-19 With Positive RT-PCR

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Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Incidence of Acute Pulmonary Embolism in Covid-19 Patients on CT Angiography and Relationship to D-dimer Levels
Actual Study Start Date : March 3, 2020
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Rate of positivity for Acute Pulmonary Embolism [ Time Frame: March 1, 2020 - March 31, 2020 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with positive SARS-Cov-2 RT-PCR
Criteria

Inclusion Criteria:

  • Positive SARS-Cov-2 RT-PCR
  • Chest CT angiography available
  • Patient is aged 18yo or above

Exclusion Criteria:

  • Expressed opposition to participate
  • Adults under guardianship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373486


Locations
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France
Service de Radiologie B - NHC
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04373486    
Other Study ID Numbers: 7840
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Covid-19
Pulmonary Embolism
CT angiography
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases