Covid-19 Effects on Arterial Stiffness and Vascular Aging (CARTESIAN)

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the presence of early vascular aging 6 months and 12 months after COVID-19 infection.

Detailed Description
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After being informed about the study and potential risks, all eligible patients giving written informed consent will undergo a comprehensive non-invasive assessment of vascular and cardiac function 6 months and 12 months after COVID-19 infection. Cardiovascular events and mortality will be collected 2, 5 and 10 years after inclusion

Official Title
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Covid-19 Effects on ARTErial StIffness and Vascular AgiNg

Conditions
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Covid19, Arterial Stiffness, Endothelial Dysfunction, Diastolic Dysfunction

Intervention / Treatment
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* Diagnostic Test: carotid-femoral pulse-wave velocity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >18 years, both sexes; written informed consent; affiliation to a social security regime; a recent diagnosis of COVID19 (6±3 months) proven by PCR or serology (for group 1,2,3) hospitalization in intensive care unit for COVID19 (for group 1) hospitalization in a medicine unit for COVID19 (for group 2) no hospitalization for COVID19 or hospitalization less than 24h (for group 3) a negative test for SARS-nCOV2 infection (PCR or serology)(for group 4) Exclusion Criteria: Age <18 years Inability to express consent of the study Diseases carrying out a life -expectancy <1 year according to clinical judgment Pregnancy and breastfeeding Foreseen inability to attend scheduled visits

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in intensive care unit | Diagnostic Test: carotid-femoral pulse-wave velocity<br>* early vascular aging tests<br>* Other names: central blood pressure;|
| Other: Group 2<br>Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in a medicine unit | Diagnostic Test: carotid-femoral pulse-wave velocity<br>* early vascular aging tests<br>* Other names: central blood pressure;|
| Other: Group 3<br>Patients with confirmed infection by SARS-Cov-2, not requiring hospitalization | Diagnostic Test: carotid-femoral pulse-wave velocity<br>* early vascular aging tests<br>* Other names: central blood pressure;|
| Other: Group 4<br>4) individuals having performed a test for SARS-Cov-2 infection, but resulted to be negative | Diagnostic Test: carotid-femoral pulse-wave velocity<br>* early vascular aging tests<br>* Other names: central blood pressure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PWV | carotid-femoral pulse wave velocity measured by application tonometry | 6 months after COVID19 infection | 
| PWV | carotid-femoral pulse wave velocity measured by application tonometry | 12 months after COVID19 infection | 
| PWV change | carotid-femoral pulse wave velocity measured by application tonometry | difference between PWV at 12 and 6 months after COVID19 infection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial distensibility | carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound | 6 months after COVID19 infection | 
| arterial distensibility | carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound | 12 months after COVID19 infection | 
| arterial distensibility change | carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound | difference between arterial distensibility at 12 and 6 months after COVID19 infection | 
| brachial artery FMD | brachial artery flow-mediated dilation for non-invasive evaluation of endothelial dysfunction, by ultrasound and automatic edge detection analysis | 6 months after COVID19 infection | 
| brachial artery FMD | brachial artery flow-mediated dilation for non-invasive evaluation of endothelial dysfunction, by ultrasound and automatic edge detection analysis | 12 months after COVID19 infection | 
| brachial artery FMD change | brachial artery flow-mediated dilation for non-invasive evaluation of endothelial dysfunction, by ultrasound and automatic edge detection analysis | difference between FMD at 12 and 6 months after COVID19 infection | 
| central blood pressure | central blood pressure obtained non-invasively by application tonometry and validated transfer function | 6 months after COVID19 infection | 
| central blood pressure | central blood pressure obtained non-invasively by application tonometry and validated transfer function | 12 months after COVID19 infection | 
| central blood pressure (BP) change | central blood pressure obtained non-invasively by application tonometry and validated transfer function | difference between central BP at 12 and 6 months after COVID19 infection | 
| wave separation/wave intensity analysis (WSA/WIA) | peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk | 6 months after COVID19 infection | 
| wave separation/wave intensity analysis (WSA/WIA) | peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk | 12 months after COVID19 infection | 
| WSA/WIA change | peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk | difference between WSA/WIA at 12 and 6 months after COVID19 infection | 
| cardiac diastolic dysfunction | E/e' at rest and after low-level exercise | 6 months after COVID19 infection | 
| cardiac diastolic dysfunction | E/e' at rest and after low-level exercise | 12 months after COVID19 infection | 
| cardiac diastolic dysfunction change | E/e' at rest and after low-level exercise | difference between cardiac diastolic dysfunction at 12 and 6 months after COVID19 infection | 
| myocardial stiffness | cardioelastography by ultrafast ultrasound | 6 months after COVID19 infection | 
| myocardial stiffness | cardioelastography by ultrafast ultrasound | 12 months after COVID19 infection | 
| myocardial stiffness change | cardioelastography by ultrafast ultrasound | difference between myocardial stiffness at 12 and 6 months after COVID19 infection | 
| carotid femoral and hearth carotid change | Mesure by laser doppler vibrometry | 6 months after COVID19 infection |