Joint Use of Electrocardiogram and Transthoracic Echocardiography With Other Clinico-biological Parameters in an Observational Study to Monitor Cardio-vascular Events and Predict Outcomes in Patients Diagnosed With COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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Joint Use of Electrocardiogram and Transthoracic Echocardiography With Other Clinico-biological Parameters in an Observational Study to Monitor Cardio-vascular Events and Predict Outcomes in Patients Diagnosed With COVID-19

Conditions
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COVID-19, Myocardial Injury, Myocarditis

Intervention / Treatment
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* Diagnostic Test: Electrocardiogram, transthoracic echocardiography and clinico-biological parameters in routine care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 patients<br>Patients diagnosed with COVID-19 by PCR done on nasal sample. | Diagnostic Test: Electrocardiogram, transthoracic echocardiography and clinico-biological parameters in routine care<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute myocardial events in COVID-19 population at baseline and during hospital stay | Viral myocarditis or myocardial infarction or stenosis detected with ST segment elevation or depression associated with troponine elevation and transthoracic echocardiography | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of cardiovascular outcomes in the cohort | 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 | During hospital admission (up to 20 days) | 
| Prognosis role of baseline cardio-vascular caracteristics on patients survival | 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 | 1st day of admission | 
| Prediction of cardio-vascular events with baseline characteristics |  | Baseline on first day of admission | 
| Characterization of inflammation on cardio-vascular outcomes | Biological markers including but not limited to: C reactive protein, procalcitonine, fibrinogen, interleukin-6 | Baseline and at day 3 day 6 day 14 and before patient is discharged (up to 20 days) | 
| Prognosis role of baseline clinico-biological caracteristics on patients transfer to ICU and survival | 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 | Baseline and at day 3 day 6 day 14 and before patient is discharged (up to 20 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronavirus, Heart conditions, Cardio-vascular outcomes