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Recruiting NCT04558450

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

No phase Interventional Covid19 Arterial Stiffness Endothelial Dysfunction Diastolic Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: carotid-femoral pulse-wave velocity.
Who it may be relevant to
Registry conditions: Covid19, Arterial Stiffness, Endothelial Dysfunction, Diastolic Dysfunction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Covid-19 Effects on ARTErial StIffness and Vascular AgiNg

Overview

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

Interventions

  • Diagnostic test carotid-femoral pulse-wave velocity
    early vascular aging tests

Primary outcome measures

  • PWV [Time frame: 6 months after COVID19 infection]
  • PWV [Time frame: 12 months after COVID19 infection]
  • PWV change [Time frame: difference between PWV at 12 and 6 months after COVID19 infection]
Secondary outcome measures (12)
  • arterial distensibility [Time frame: 6 months after COVID19 infection]
  • arterial distensibility [Time frame: 12 months after COVID19 infection]
  • arterial distensibility change [Time frame: difference between arterial distensibility at 12 and 6 months after COVID19 infection]
  • brachial artery FMD [Time frame: 6 months after COVID19 infection]
  • brachial artery FMD [Time frame: 12 months after COVID19 infection]
  • brachial artery FMD change [Time frame: difference between FMD at 12 and 6 months after COVID19 infection]
  • central blood pressure [Time frame: 6 months after COVID19 infection]
  • central blood pressure [Time frame: 12 months after COVID19 infection]
  • central blood pressure (BP) change [Time frame: difference between central BP at 12 and 6 months after COVID19 infection]
  • wave separation/wave intensity analysis (WSA/WIA) [Time frame: 6 months after COVID19 infection]
  • wave separation/wave intensity analysis (WSA/WIA) [Time frame: 12 months after COVID19 infection]
  • WSA/WIA change [Time frame: difference between WSA/WIA at 12 and 6 months after COVID19 infection]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 3 centers
  • CHRU Nancy — Nancy
  • Hôpital Européen Georges Pompidou - APHP — Paris
  • CHU Rouen — Rouen

Identifiers

NCT: NCT04558450 · APHP200762 · APHP200762 · 20.07.24.57438

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗