Cardiovascular Complications and COVID-19 (CovCardioVasc-Study)

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Unknown status

CT.gov ID

NCT04335162

Collaborator

(none)

100

Enrollment

Locations

18.1

Anticipated Duration (Months)

12.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID Acute Coronary Syndrome Myocardial Infarction Myocarditis Venous Thromboembolism Deep Vein Thrombosis Pulmonary Embolism

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cardiovascular Complications in Patients With COVID-19

Actual Study Start Date :

Feb 28, 2020

Anticipated Primary Completion Date :

Aug 31, 2021

Anticipated Study Completion Date :

Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Patients with cardiovascular complications Patients presenting with cardiomyopathies or venous thromboembolism
Patients without cardiovascular complications Patients without cardiomyopathies or venous thromboembolism
Intensive Care Unit patients Patients admitted in intensive care unit
Hospital Ward patients Patients admitted in hospital ward

Outcome Measures

Primary Outcome Measures

Determine the incidence of cardiomyopathies and venous thromboembolism [28 days]
Incidence of cardiomyopathies and/or venous thromboembolism at day 28

Secondary Outcome Measures

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
length of stay [hospitalisation duration]
Number of day at hospital
Mechanical ventilation [hospitalisation duration]
Setting up or not of mechanical ventilation
Renal replacement therapy [hospitalisation duration]
Administration or not of renal replacement therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Hospitalier de Cannes	Cannes	France	06400
2	CHU de Dijon	Dijon	France
3	Centre Hospitalier de Draguignan	Draguignan	France	83300
4	Centre Hospitalier de Grasse	Grasse	France	06130
5	Clinique Ambroise-Paré	Neuilly	France
6	CHU de Nice	Nice	France	06200
7	Hôpitaux Universitaires Paris Centre - Hôpital Cochin	Paris	France	75014
8	CHU de REIMS	Reims	France