Clinical trial NCT04335162: Cardiovascular Complications and COVID-19 (CovCardioVasc-Study)
Official title: Cardiovascular Complications in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Acute Coronary Syndrome
Myocardial Infarction
Myocarditis
Venous Thromboembolism
Deep Vein Thrombosis
Pulmonary Embolism
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive care unit, hospital ward

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.


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

Primary outcomes:
measure: Determine the incidence of cardiomyopathies and venous thromboembolism
timeFrame: 28 days
Secondary outcomes:
measure: Mortality
timeFrame: 28 days
measure: Duration of mechanical ventilation
timeFrame: hospitalisation duration
measure: Shock
timeFrame: hospitalisation duration
measure: length of stay
timeFrame: hospitalisation duration
measure: Mechanical ventilation
timeFrame: hospitalisation duration
measure: Renal replacement therapy
timeFrame: hospitalisation duration
Other outcomes:
Locations:
city: Cannes
country: France
facility: Centre Hospitalier de Cannes
city: Dijon
country: France
facility: CHU de Dijon
city: Draguignan
country: France
facility: Centre Hospitalier de Draguignan
city: Grasse
country: France
facility: Centre Hospitalier de Grasse
city: Neuilly
country: France
facility: Clinique Ambroise-Paré
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Hôpitaux Universitaires Paris Centre - Hôpital Cochin
city: Reims
country: France
facility: CHU de REIMS
Study officials:
affiliation: CHU de NICE - Archet 1
name: Denis DOYEN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferrari E, Sartre B, Squara F, Contenti J, Occelli C, Lemoel F, Levraut J, Doyen D, Dellamonica J, Mondain V, Chirio D, Risso K, Cua E, Orban JC, Ichai C, Labbaoui M, Mossaz B, Moceri P, Appert-Flory A, Fischer F, Toulon P. High Prevalence of Acquired Thrombophilia Without Prognosis Value in Patients With Coronavirus Disease 2019. J Am Heart Assoc. 2020 Nov 3;9(21):e017773. doi: 10.1161/JAHA.120.017773. Epub 2020 Sep 25.