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

Not Applicable

Recruiting

• Conditions: Covid19; Endothelial Dysfunction; Arterial Stiffness; Diastolic Dysfunction
• Interventions: Diagnostic Test: carotid-femoral pulse-wave velocity

• Registration Number: NCT04558450
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study First Submitted: 2020-08-31
• Study Start: 2020-09-21
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-22
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-22
• Primary Completion: 2023-03
• Study Completion: 2033-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 2	carotid-femoral pulse-wave velocity	Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in a medicine unit
Group 3	carotid-femoral pulse-wave velocity	Patients with confirmed infection by SARS-Cov-2, not requiring hospitalization
Group 1	carotid-femoral pulse-wave velocity	Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in intensive care unit
Group 4	carotid-femoral pulse-wave velocity	4) individuals having performed a test for SARS-Cov-2 infection, but resulted to be negative

Primary Outcome Measures

Name	Time	Method
PWV	12 months after COVID19 infection	carotid-femoral pulse wave velocity measured by application tonometry
PWV change	difference between PWV at 12 and 6 months after COVID19 infection	carotid-femoral pulse wave velocity measured by application tonometry

Secondary Outcome Measures

Name	Time	Method
wave separation/wave intensity analysis (WSA/WIA)	12 months after COVID19 infection	peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk
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	12 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	12 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
arterial distensibility	12 months after COVID19 infection	carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound
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	12 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	12 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

Trial Locations

Locations (3)

CHU Rouen; 🇫🇷 Rouen, France

Hôpital Européen Georges Pompidou - APHP; 🇫🇷 Paris, France

CHRU Nancy; 🇫🇷 Nancy, France