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

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Completed
CT.gov ID
NCT04373486
Collaborator
(none)
160
Enrollment
1
Location
1.9
Actual Duration (Months)
82.5
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Mar 3, 2020
    Actual Primary Completion Date :
    Apr 30, 2020
    Actual Study Completion Date :
    May 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Rate of positivity for Acute Pulmonary Embolism [March 1, 2020 - March 31, 2020]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Radiologie B - NHC Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT04373486
    Other Study ID Numbers:
    • 7840
    First Posted:
    May 4, 2020
    Last Update Posted:
    Jan 11, 2021
    Last Verified:
    Apr 1, 2020
    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:
    COVID-19
    Pulmonary Embolism
    Embolism

    Study Results

    No Results Posted as of Jan 11, 2021