Cardiovascular Complications and COVID-19 (CovCardioVasc-Study)

Completed

• Conditions: COVID; Venous Thromboembolism; Myocardial Infarction; Deep Vein Thrombosis; Acute Coronary Syndrome; Myocarditis; Pulmonary Embolism

• Registration Number: NCT04335162
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-28
• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-06
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the incidence of cardiomyopathies and venous thromboembolism	28 days	Incidence of cardiomyopathies and/or venous thromboembolism at day 28

Secondary Outcome Measures

Name	Time	Method
Mortality	28 days	Incidence of mortality at day 28
Duration of mechanical ventilation	hospitalisation duration	Number of day of using mechanical ventilation for each patients
Shock	hospitalisation duration	Incidence of shock during hospitalisation
Renal replacement therapy	hospitalisation duration	Administration or not of renal replacement therapy
length of stay	hospitalisation duration	Number of day at hospital
Mechanical ventilation	hospitalisation duration	Setting up or not of mechanical ventilation

Trial Locations

Locations (8)

Centre Hospitalier de Cannes; 🇫🇷 Cannes, France

CHU de Dijon; 🇫🇷 Dijon, France

Centre Hospitalier de Draguignan; 🇫🇷 Draguignan, France

Centre Hospitalier de Grasse; 🇫🇷 Grasse, France

Clinique Ambroise-Paré; 🇫🇷 Neuilly, France

CHU de Nice; 🇫🇷 Nice, France

Hôpitaux Universitaires Paris Centre - Hôpital Cochin; 🇫🇷 Paris, France

CHU de REIMS; 🇫🇷 Reims, France