Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID04558450

Covid-19 Effects on Arterial Stiffness and Vascular Aging

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2021-11-22

360

Participants Needed

3

Research Sites

521 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

T

The Association for Research into Arterial Structure and Physiology

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the effects of COVID-19 infection on early vascular aging by studying arterial stiffness and related cardiovascular changes. The study evaluates these effects at 6 months and 12 months after infection, including patients with varying severity of COVID-19, from those hospitalized in intensive care to those not requiring hospitalization, as well as individuals who tested negative for the virus. The study aims to understand vascular and cardiac function changes and long-term cardiovascular events and mortality over several years. Participants undergo non-invasive vascular and cardiac assessments, including measurements of carotid-femoral pulse-wave velocity and other vascular tests, at 6 and 12 months following COVID-19 infection or testing. The study groups include patients hospitalized in intensive care, those hospitalized in medicine units, patients with mild or no hospitalization, and a control group with negative SARS-CoV-2 tests. Cardiovascular events and mortality data will be collected at 2, 5, and 10 years after enrollment. During the study, participants will have vascular and cardiac function tests to measure arterial stiffness, arterial distensibility, blood pressure, and cardiac function at specified time points. Researchers will track changes between 6 and 12 months after infection to assess progression or improvement. Long-term follow-up includes tracking cardiovascular events and mortality over up to 10 years. Participants provide written informed consent and must be able to attend scheduled visits for assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years, both sexes
  • Written informed consent
  • Affiliation to a social security regime
  • Recent COVID-19 diagnosis (6\u00b13 months) confirmed by PCR or serology for groups 1, 2, and 3
  • Hospitalization in intensive care unit for COVID-19 (group 1)
  • Hospitalization in a medicine unit for COVID-19 (group 2)
  • No hospitalization or hospitalization less than 24 hours for COVID-19 (group 3)
  • Negative test for SARS-nCOV2 infection (PCR or serology) for group 4
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Inability to provide informed consent
  • Diseases with life expectancy less than 1 year
  • Pregnancy and breastfeeding
  • Expected inability to attend scheduled visits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - From 6 months to 12 months after COVID-19 infection

Participants undergo comprehensive non-invasive assessments of vascular and cardiac function at 6 months and 12 months after COVID-19 infection.

2 visits (in-person)

Long-term Monitoring

Duration - Up to 10 years after inclusion

Participants are monitored for cardiovascular events and mortality up to 10 years after inclusion.

3 visits over 10 years (in-person or remote)

Trial Site Locations

Total: 3 locations

1

CHRU Nancy

Nancy, France, 54500

Actively Recruiting

2

Hôpital Européen Georges Pompidou - APHP

Paris, France, 75015

Actively Recruiting

3

CHU Rouen

Rouen, France, 76031

Actively Recruiting

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Research Team

R

Rosa Maria BRUNO, MD

L

Laura LE MAO, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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