Arterial Stiffness, Covid19, Diastolic Dysfunction, Endothelial Dysfunction
Conditions
Brief summary
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
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
Interventions
DIAGNOSTIC_TESTcarotid-femoral pulse-wave velocity
early vascular aging tests
Sponsors
The Association for Research into Arterial Structure and Physiology
Institut National de la Santé Et de la Recherche Médicale, France
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PWV change | difference between PWV at 12 and 6 months after COVID19 infection | carotid-femoral pulse wave velocity measured by application tonometry |
| PWV | 6 months after COVID19 infection | carotid-femoral pulse wave velocity measured by application tonometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| arterial distensibility change | difference between arterial distensibility at 12 and 6 months after COVID19 infection | carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound |
| brachial artery FMD | 6 months after COVID19 infection | brachial artery flow-mediated dilation for non-invasive evaluation of endothelial dysfunction, by ultrasound and automatic edge detection analysis |
| brachial artery FMD change | difference between FMD at 12 and 6 months after COVID19 infection | brachial artery flow-mediated dilation for non-invasive evaluation of endothelial dysfunction, by ultrasound and automatic edge detection analysis |
| central blood pressure | 6 months after COVID19 infection | central blood pressure obtained non-invasively by application tonometry and validated transfer function |
| central blood pressure (BP) change | difference between central BP at 12 and 6 months after COVID19 infection | central blood pressure obtained non-invasively by application tonometry and validated transfer function |
| WSA/WIA change | difference between WSA/WIA at 12 and 6 months after COVID19 infection | peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk |
| cardiac diastolic dysfunction | 6 months after COVID19 infection | E/e' at rest and after low-level exercise |
| cardiac diastolic dysfunction change | difference between cardiac diastolic dysfunction at 12 and 6 months after COVID19 infection | E/e' at rest and after low-level exercise |
| myocardial stiffness | 6 months after COVID19 infection | cardioelastography by ultrafast ultrasound |
| myocardial stiffness change | difference between myocardial stiffness at 12 and 6 months after COVID19 infection | cardioelastography by ultrafast ultrasound |
| carotid femoral and hearth carotid change | 6 months after COVID19 infection | Mesure by laser doppler vibrometry |
| wave separation/wave intensity analysis (WSA/WIA) | 6 months after COVID19 infection | peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk |
| arterial distensibility | 6 months after COVID19 infection | carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound |
Other
| Measure | Time frame | Description |
|---|---|---|
| total mortality | 2 years | individual data will be meta-analyzed with sister studies running in parallel worldwide |
| CV events | 2 years | fatal+non-fatal |
Countries
France
Contacts
Primary ContactRosa Maria BRUNO, MD
Backup ContactLaura LE MAO, MSc
Outcome results
None listed