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Clinical Trials/NCT04335162
NCT04335162CompletedNot Applicable

Cardiovascular Complications in Patients With COVID-19

Centre Hospitalier Universitaire de Nice8 sites in 1 country198 target enrollmentStarted: February 28, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
198
Locations
8
Primary Endpoint
Determine the incidence of cardiomyopathies and venous thromboembolism

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (8)

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