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Clinical Trials/NCT04335162
NCT04335162
Completed
Not Applicable

Cardiovascular Complications in Patients With COVID-19

Centre Hospitalier Universitaire de Nice8 sites in 1 country198 target enrollmentFebruary 28, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
198
Locations
8
Primary Endpoint
Determine the incidence of cardiomyopathies and venous thromboembolism
Status
Completed
Last Updated
last year

Overview

Brief Summary

Patients with COVID-19 in the Intensive Care Unit (ICU) or hospitalized with severe form have a poor prognosis (almost 30% rate of death). They present often a high cardiovascular risk profile (almost 30% of hypertension and 19% of diabetes). Troponin has been described to be elevated in a high proportion of patients (one fifth of all patients and 50% of non-survivors) suggesting the possibility of cardiomyopathies. High levels of DDimers (81% of non survivors) and fibrin degradation products are also associated with increased risk of mortality suggesting also the possibility of venous thromboembolism. Therefore, screening for cardiomyopathies and venous thromboembolism could represent an important challenge for patients with COVID-19 management.

Registry
clinicaltrials.gov
Start Date
February 28, 2020
End Date
August 31, 2021
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All consecutive patients with COVID-19 infection admitted to the ICU or hospitalized because of severe form (eg: hypoxia, orthopnea, pneumonitis, kidney insufficiency) will be included

Exclusion Criteria

  • Patients under 18 years

Outcomes

Primary Outcomes

Determine the incidence of cardiomyopathies and venous thromboembolism

Time Frame: 28 days

Incidence of cardiomyopathies and/or venous thromboembolism at day 28

Secondary Outcomes

  • Mortality(28 days)
  • Duration of mechanical ventilation(hospitalisation duration)
  • Shock(hospitalisation duration)
  • Renal replacement therapy(hospitalisation duration)
  • length of stay(hospitalisation duration)
  • Mechanical ventilation(hospitalisation duration)

Study Sites (8)

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