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

Covid-19 Effects on ARTErial StIffness and Vascular AgiNg

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

Study Overview

• Status: Recruiting
• Conditions: Covid19; Endothelial Dysfunction; Diastolic Dysfunction; Arterial Stiffness
• Intervention / Treatment: Diagnostic test: carotid-femoral pulse-wave velocity

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 Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rosa Maria BRUNO, MD; Phone Number: +33 1 53 98 79 67; Email: rosa-maria.bruno@inserm.fr
• Study Contact Backup: Name: Laura LE MAO, MSc; Phone Number: +33 1 56 09 54 97; Email: laura.le-mao@aphp.fr

Study Locations

• France
  • Nancy, France, 54500
    • Recruiting
    • CHRU Nancy
    • Contact: Athanase BENETOS, PhD; Phone Number: + 33 3 83 15 33 22; Email: a.benetos@chru-nancy.fr
  • Paris, France, 75015
    • Recruiting
    • Hôpital européen Georges Pompidou - APHP
    • Contact: Pierre BOUTOUYRIE, PUPH; Phone Number: +33 1 56 09 39 91; Email: Pierre.boutouyrie@aphp.fr
  • Rouen, France, 76031
    • Recruiting
    • CHU Rouen
    • Contact: Jérémy BELLIEN, PUPH; Phone Number: +33 2 32 88 14 28; Email: jeremy.bellien@chu.rouen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1; Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in intensive care unit	Diagnostic test: carotid-femoral pulse-wave velocity; early vascular aging tests; Other Names: arterial distensibility; wave separation/intensity analysis; flow-mediated dilation; cardiac diastolic dysfunction; myocardial stiffness; central blood pressure
Other: Group 2; Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in a medicine unit	Diagnostic test: carotid-femoral pulse-wave velocity; early vascular aging tests; Other Names: arterial distensibility; wave separation/intensity analysis; flow-mediated dilation; cardiac diastolic dysfunction; myocardial stiffness; central blood pressure
Other: Group 3; Patients with confirmed infection by SARS-Cov-2, not requiring hospitalization	Diagnostic test: carotid-femoral pulse-wave velocity; early vascular aging tests; Other Names: arterial distensibility; wave separation/intensity analysis; flow-mediated dilation; cardiac diastolic dysfunction; myocardial stiffness; central blood pressure
Other: Group 4; 4) individuals having performed a test for SARS-Cov-2 infection, but resulted to be negative	Diagnostic test: carotid-femoral pulse-wave velocity; early vascular aging tests; Other Names: arterial distensibility; wave separation/intensity analysis; flow-mediated dilation; cardiac diastolic dysfunction; myocardial stiffness; central blood pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PWV	carotid-femoral pulse wave velocity measured by application tonometry	6 months after COVID19 infection
PWV	carotid-femoral pulse wave velocity measured by application tonometry	12 months after COVID19 infection
PWV change	carotid-femoral pulse wave velocity measured by application tonometry	difference between PWV at 12 and 6 months after COVID19 infection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
arterial distensibility	carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound	6 months after COVID19 infection
arterial distensibility	carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound	12 months after COVID19 infection
arterial distensibility change	carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound	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	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	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	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	6 months after COVID19 infection
central blood pressure	central blood pressure obtained non-invasively by application tonometry and validated transfer function	12 months after COVID19 infection
central blood pressure (BP) change	central blood pressure obtained non-invasively by application tonometry and validated transfer function	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	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	12 months after COVID19 infection
WSA/WIA change	peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk	difference between WSA/WIA at 12 and 6 months after COVID19 infection
cardiac diastolic dysfunction	E/e' at rest and after low-level exercise	6 months after COVID19 infection
cardiac diastolic dysfunction	E/e' at rest and after low-level exercise	12 months after COVID19 infection
cardiac diastolic dysfunction change	E/e' at rest and after low-level exercise	difference between cardiac diastolic dysfunction at 12 and 6 months after COVID19 infection
myocardial stiffness	cardioelastography by ultrafast ultrasound	6 months after COVID19 infection
myocardial stiffness	cardioelastography by ultrafast ultrasound	12 months after COVID19 infection
myocardial stiffness change	cardioelastography by ultrafast ultrasound	difference between myocardial stiffness at 12 and 6 months after COVID19 infection
carotid femoral and hearth carotid change	Mesure by laser doppler vibrometry	6 months after COVID19 infection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
total mortality	individual data will be meta-analyzed with sister studies running in parallel worldwide	2 years
total mortality	individual data will be meta-analyzed with sister studies running in parallel worldwide	5 years
total mortality	individual data will be meta-analyzed with sister studies running in parallel worldwide	10 years
CV events	fatal+non-fatal	2 years
CV events	fatal+non-fatal	5 years
CV events	fatal+non-fatal	10 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; The Association for Research into Arterial Structure and Physiology
• Investigators: Principal Investigator: Pierre BOUTOUYRIE, MD PHD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

Helpful Links

• general description of the study
• summary and presentation of the global CARTESIAN initiative

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2033

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: APHP200762 (Other Identifier: ANSM); 20.07.24.57438 (Other Identifier: CNRIPH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
• IPD Sharing Time Frame: One year after the last publication

IPD Sharing Access Criteria

Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team. The founder could be involved in the decision.

Teams wishing obtain IPD must meet the sponsor and PI team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.

• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No