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

Assistance Publique - Hôpitaux de Paris360 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

360

Conditions

Covid19 Arterial Stiffness Endothelial Dysfunction Diastolic Dysfunction

Interventions

carotid-femoral pulse-wave velocityDIAGNOSTIC_TEST

early vascular aging tests

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

CHRU Nancy

Nancy, France

RECRUITING

Hôpital Européen Georges Pompidou - APHP

Paris, France

RECRUITING

CHU Rouen

Rouen, France

RECRUITING

Outcomes

Primary Outcomes

PWV

carotid-femoral pulse wave velocity measured by application tonometry

Time frame: 6 months after COVID19 infection

PWV

carotid-femoral pulse wave velocity measured by application tonometry

Time frame: 12 months after COVID19 infection

PWV change

carotid-femoral pulse wave velocity measured by application tonometry

Time frame: difference between PWV at 12 and 6 months after COVID19 infection

Secondary Outcomes

arterial distensibility

carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound

Time frame: 6 months after COVID19 infection

arterial distensibility

carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound

Time frame: 12 months after COVID19 infection

arterial distensibility change

carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound

Time frame: 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

Time frame: 6 months after COVID19 infection

brachial artery FMD

Central Contacts

Rosa Maria BRUNO, MD

CONTACT

+33 1 53 98 79 67 rosa-maria.bruno@inserm.fr

Laura LE MAO, MSc

CONTACT

+33 1 56 09 54 97 laura.le-mao@aphp.fr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

brachial artery flow-mediated dilation for non-invasive evaluation of endothelial dysfunction, by ultrasound and automatic edge detection analysis

Time frame: 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

Time frame: 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

Time frame: 6 months after COVID19 infection

central blood pressure

central blood pressure obtained non-invasively by application tonometry and validated transfer function

Time frame: 12 months after COVID19 infection

central blood pressure (BP) change

central blood pressure obtained non-invasively by application tonometry and validated transfer function

Time frame: 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

Time frame: 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

Time frame: 12 months after COVID19 infection

WSA/WIA change

peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk

Time frame: difference between WSA/WIA at 12 and 6 months after COVID19 infection

cardiac diastolic dysfunction

E/e' at rest and after low-level exercise

Time frame: 6 months after COVID19 infection

cardiac diastolic dysfunction

E/e' at rest and after low-level exercise

Time frame: 12 months after COVID19 infection

cardiac diastolic dysfunction change

E/e' at rest and after low-level exercise

Time frame: difference between cardiac diastolic dysfunction at 12 and 6 months after COVID19 infection

myocardial stiffness

cardioelastography by ultrafast ultrasound

Time frame: 6 months after COVID19 infection

myocardial stiffness

cardioelastography by ultrafast ultrasound

Time frame: 12 months after COVID19 infection

myocardial stiffness change

cardioelastography by ultrafast ultrasound

Time frame: difference between myocardial stiffness at 12 and 6 months after COVID19 infection

carotid femoral and hearth carotid change

Mesure by laser doppler vibrometry

Time frame: 6 months after COVID19 infection