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ClinicalTrials.gov ID

NCT04558450

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

360Estimated

Last Update Posted

Nov 22, 2021Actual

Start Date

Sep 21, 2020Actual

Primary Completion Date

Mar 2023Estimated

Completion Date

Mar 2033Estimated

Official Title

Covid-19 Effects on ARTErial StIffness and Vascular AgiNg

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

• Covid19
• Arterial Stiffness
• Endothelial Dysfunction
• Diastolic Dysfunction

• carotid-femoral pulse-wave velocity

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

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 Purpose

Diagnostic

Allocation

Non-Randomized

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

The Association for Research into Arterial Structure and PhysiologyUNKNOWN

Institut National de la Santé Et de la Recherche Médicale, FranceOTHER_GOV

jeremy.bellien@chu.rouen.fr+33 2 32 88 14 28