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

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Diastolic Dysfunction; Endothelial Dysfunction; Covid19; Arterial Stiffness

Treatments: Diagnostic Test: carotid-femoral pulse-wave velocity

Study type: Interventional

Funder types: Other

Identifiers

NCT04558450

20.07.24.57438 (Other Identifier)

APHP200762 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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360 participants in 4 patient groups

Group 1

Other group

Description:

Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in intensive care unit

Treatment:

Diagnostic Test: carotid-femoral pulse-wave velocity

Group 2

Other group

Description:

Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in a medicine unit

Treatment:

Diagnostic Test: carotid-femoral pulse-wave velocity

Group 3

Other group

Description:

Patients with confirmed infection by SARS-Cov-2, not requiring hospitalization

Treatment:

Diagnostic Test: carotid-femoral pulse-wave velocity

Group 4

Other group

Description:

4) individuals having performed a test for SARS-Cov-2 infection, but resulted to be negative

Treatment:

Diagnostic Test: carotid-femoral pulse-wave velocity