COVID-19, Myocardial Injury, Myocarditis
Conditions
Keywords
Coronavirus, Heart conditions, Cardio-vascular outcomes
Brief summary
COVID-19 outbreak is often lethal. Mortality has been associated with several cardio-vascular risk factors such as diabetes, obesity, hypertension and tobacco use. Other clinico-biological features predictive of mortality or transfer to Intensive Care Unit are also needed. Cases of myocarditis have also been reported with COVID-19. Cardio-vascular events have possibly been highly underestimated. The study proposes to systematically collect cardio-vascular data to study the incidence of myocarditis and coronaropathy events during COVID-19 infection.We will also assess predictive factors for transfer in Intensive Care Unit or death.
Interventions
DIAGNOSTIC_TESTElectrocardiogram, transthoracic echocardiography and clinico-biological parameters in routine care
* 12 derivations electrocardiogram done at baseline and repeated every 3 days * transthoracic echocardiography at baseline * clinical features at baseline: WHO performans status comorbidities and treatments * biological results in routine care, such as baseline full blood count, inflammation markers: C-reactive protein, procalcitonin, interleukin-6 and ferritin, coagulation and troponin and brain natriuretic peptide
Sponsors
Groupe Hospitalier Pitie-Salpetriere
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- COVID-19 positive patients admitted in a ward identified by positive PCR on nasal swab samples
Exclusion criteria
\- Patients who refused the use of their routine care data after information by investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute myocardial events in COVID-19 population at baseline and during hospital stay | ECG and concomitant troponine at day 1 after admission at day 1, day 3 day 6 the first week after admission, and then at day 14 and before the patient is discharged (up to 20 days) | Viral myocarditis or myocardial infarction or stenosis detected with ST segment elevation or depression associated with troponine elevation and transthoracic echocardiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of cardiovascular outcomes in the cohort | During hospital admission (up to 20 days) | Cardio-vascular events including but not limited to: myocardial infarction or stenosis, stroke, pulmonary embolism, deep vein thrombosis, ventricular dysfunctio, conduction disorders and sudden death |
| Prognosis role of baseline cardio-vascular caracteristics on patients survival | 1st day of admission | Biological biomarkers including but not limited to: baseline troponine T, D-dimers, NT-proBNP, creatinine phosphokinase, creatininemia, ionogram, renine-angiotensin aldosterone system profiling, glycemia (fasting), HbA1c, steroid profiling, lipid profiling |
| Prediction of cardio-vascular events with baseline characteristics | Baseline on first day of admission | — |
| Characterization of inflammation on cardio-vascular outcomes | Baseline and at day 3 day 6 day 14 and before patient is discharged (up to 20 days) | Biological markers including but not limited to: C reactive protein, procalcitonine, fibrinogen, interleukin-6 |
| Prognosis role of baseline clinico-biological caracteristics on patients transfer to ICU and survival | Baseline and at day 3 day 6 day 14 and before patient is discharged (up to 20 days) | clinical features at baseline: WHO performans status comorbidities and treatments Biological markers including but not limited to: full blood count, C reactive protein, procalcitonine, fibrinogen, interleukin-6, troponin and brain natriuretic peptide |
Countries
France
Outcome results
None listed