Clinical trial NCT04558450: Covid-19 Effects on Arterial Stiffness and Vascular Aging (CARTESIAN)
Official title: Covid-19 Effects on ARTErial StIffness and Vascular AgiNg
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Covid19
Arterial Stiffness
Endothelial Dysfunction
Diastolic Dysfunction
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: The Association for Research into Arterial Structure and Physiology
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2020-09-22
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: PWV
timeFrame: 6 months after COVID19 infection
measure: PWV
timeFrame: 12 months after COVID19 infection
measure: PWV change
timeFrame: difference between PWV at 12 and 6 months after COVID19 infection
Secondary outcomes:
measure: arterial distensibility
timeFrame: 6 months after COVID19 infection
measure: arterial distensibility
timeFrame: 12 months after COVID19 infection
measure: arterial distensibility change
timeFrame: difference between arterial distensibility at 12 and 6 months after COVID19 infection
measure: brachial artery FMD
timeFrame: 6 months after COVID19 infection
measure: brachial artery FMD
timeFrame: 12 months after COVID19 infection
measure: brachial artery FMD change
timeFrame: difference between FMD at 12 and 6 months after COVID19 infection
measure: central blood pressure
timeFrame: 6 months after COVID19 infection
measure: central blood pressure
timeFrame: 12 months after COVID19 infection
measure: central blood pressure (BP) change
timeFrame: difference between central BP at 12 and 6 months after COVID19 infection
measure: wave separation/wave intensity analysis (WSA/WIA)
timeFrame: 6 months after COVID19 infection
measure: wave separation/wave intensity analysis (WSA/WIA)
timeFrame: 12 months after COVID19 infection
measure: WSA/WIA change
timeFrame: difference between WSA/WIA at 12 and 6 months after COVID19 infection
measure: cardiac diastolic dysfunction
timeFrame: 6 months after COVID19 infection
measure: cardiac diastolic dysfunction
timeFrame: 12 months after COVID19 infection
measure: cardiac diastolic dysfunction change
timeFrame: difference between cardiac diastolic dysfunction at 12 and 6 months after COVID19 infection
measure: myocardial stiffness
timeFrame: 6 months after COVID19 infection
measure: myocardial stiffness
timeFrame: 12 months after COVID19 infection
measure: myocardial stiffness change
timeFrame: difference between myocardial stiffness at 12 and 6 months after COVID19 infection
measure: carotid femoral and hearth carotid change
timeFrame: 6 months after COVID19 infection
Other outcomes:
measure: total mortality
timeFrame: 2 years
measure: total mortality
timeFrame: 5 years
measure: total mortality
timeFrame: 10 years
measure: CV events
timeFrame: 2 years
measure: CV events
timeFrame: 5 years
measure: CV events
timeFrame: 10 years
Locations:
city: Nancy
country: France
facility: CHRU Nancy
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou - APHP
city: Rouen
country: France
facility: CHU Rouen
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pierre BOUTOUYRIE, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: