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Completed

NCT Number: NCT04335162

Cardiovascular Complications and COVID-19 (CovCardioVasc-Study)

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.

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Key information

Conditions

COVID Acute Coronary Syndrome Cardiomyopathies Cardiovascular Diseases Deep Vein Thrombosis Embolism Embolism and Thrombosis Heart Diseases Infarction Ischemia Lung Diseases Myocardial Infarction Myocardial Ischemia Myocarditis Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de Cannes, Cannes, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Determine the incidence of cardiomyopathies and venous thromboembolism

    Time frame: 28 days

    Incidence of cardiomyopathies and/or venous thromboembolism at day 28

Secondary outcomes

  1. Mortality

    Time frame: 28 days

    Incidence of mortality at day 28

  2. Duration of mechanical ventilation

    Time frame: hospitalisation duration

    Number of day of using mechanical ventilation for each patients

  3. Shock

    Time frame: hospitalisation duration

    Incidence of shock during hospitalisation

  4. length of stay

    Time frame: hospitalisation duration

    Number of day at hospital

  5. Mechanical ventilation

    Time frame: hospitalisation duration

    Setting up or not of mechanical ventilation

  6. Renal replacement therapy

    Time frame: hospitalisation duration

    Administration or not of renal replacement therapy

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Cardiovascular Complications in Patients With COVID-19

Acronym: CovCardioVasc

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 6, 2020
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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