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NCT Number: NCT04558450

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

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

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Key information

Conditions

Covid19 Arterial Stiffness COVID-19 Coronaviridae Infections Coronavirus Infections Diastolic Dysfunction Endothelial Dysfunction Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Nancy, Nancy, France

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carotid-femoral pulse-wave velocity

Diagnostic Test

early vascular aging tests

Other names: arterial distensibility, wave separation/intensity analysis, flow-mediated dilation, cardiac diastolic dysfunction, myocardial stiffness, central blood pressure

Primary outcomes

  1. PWV

    Time frame: 6 months after COVID19 infection

    carotid-femoral pulse wave velocity measured by application tonometry

  2. PWV

    Time frame: 12 months after COVID19 infection

    carotid-femoral pulse wave velocity measured by application tonometry

  3. PWV change

    Time frame: difference between PWV at 12 and 6 months after COVID19 infection

    carotid-femoral pulse wave velocity measured by application tonometry

Secondary outcomes

  1. arterial distensibility

    Time frame: 6 months after COVID19 infection

    carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound

  2. arterial distensibility

    Time frame: 12 months after COVID19 infection

    carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound

  3. arterial distensibility change

    Time frame: difference between arterial distensibility at 12 and 6 months after COVID19 infection

    carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound

  4. brachial artery FMD

    Time frame: 6 months after COVID19 infection

    brachial artery flow-mediated dilation for non-invasive evaluation of endothelial dysfunction, by ultrasound and automatic edge detection analysis

  5. brachial artery FMD

    Time frame: 12 months after COVID19 infection

    brachial artery flow-mediated dilation for non-invasive evaluation of endothelial dysfunction, by ultrasound and automatic edge detection analysis

  6. brachial artery FMD change

    Time frame: 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

  7. central blood pressure

    Time frame: 6 months after COVID19 infection

    central blood pressure obtained non-invasively by application tonometry and validated transfer function

  8. central blood pressure

    Time frame: 12 months after COVID19 infection

    central blood pressure obtained non-invasively by application tonometry and validated transfer function

  9. central blood pressure (BP) change

    Time frame: 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

  10. wave separation/wave intensity analysis (WSA/WIA)

    Time frame: 6 months after COVID19 infection

    peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk

  11. wave separation/wave intensity analysis (WSA/WIA)

    Time frame: 12 months after COVID19 infection

    peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk

  12. WSA/WIA change

    Time frame: 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

  13. cardiac diastolic dysfunction

    Time frame: 6 months after COVID19 infection

    E/e' at rest and after low-level exercise

  14. cardiac diastolic dysfunction

    Time frame: 12 months after COVID19 infection

    E/e' at rest and after low-level exercise

  15. cardiac diastolic dysfunction change

    Time frame: difference between cardiac diastolic dysfunction at 12 and 6 months after COVID19 infection

    E/e' at rest and after low-level exercise

  16. myocardial stiffness

    Time frame: 6 months after COVID19 infection

    cardioelastography by ultrafast ultrasound

  17. myocardial stiffness

    Time frame: 12 months after COVID19 infection

    cardioelastography by ultrafast ultrasound

  18. myocardial stiffness change

    Time frame: difference between myocardial stiffness at 12 and 6 months after COVID19 infection

    cardioelastography by ultrafast ultrasound

  19. carotid femoral and hearth carotid change

    Time frame: 6 months after COVID19 infection

    Mesure by laser doppler vibrometry

Other outcomes

  1. total mortality

    Time frame: 2 years

    individual data will be meta-analyzed with sister studies running in parallel worldwide

  2. total mortality

    Time frame: 5 years

    individual data will be meta-analyzed with sister studies running in parallel worldwide

  3. total mortality

    Time frame: 10 years

    individual data will be meta-analyzed with sister studies running in parallel worldwide

  4. CV events

    Time frame: 2 years

    fatal+non-fatal

  5. CV events

    Time frame: 5 years

    fatal+non-fatal

  6. CV events

    Time frame: 10 years

    fatal+non-fatal

Study contacts

Contact information is provided by the study sponsor or research team.

Laura LE MAO, MSc

CONTACT

[email protected]

+33 1 56 09 54 97

Rosa Maria BRUNO, MD

CONTACT

[email protected]

+33 1 53 98 79 67

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • The Association for Research into Arterial Structure and Physiology

Registry information

Official study title

Covid-19 Effects on ARTErial StIffness and Vascular AgiNg

Acronym: CARTESIAN

Important dates

Study start
2020
Primary completion
2023
Study completion
2033
First posted
Sep 22, 2020
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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