Covid-19 Effects on Arterial Stiffness and Vascular Aging (CARTESIAN)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
The purpose of the study is to evaluate the presence of early vascular aging 6 months and 12 months after COVID-19 infection.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
carotid-femoral pulse-wave velocity
Diagnostic testearly vascular aging tests
Treatment groups
360 Participants
are divided into 4 treatment groupsGroup A: Group 1Other 1 intervention
Group B: Group 2Other 1 intervention
Group C: Group 3Other 1 intervention
Group D: Group 4Other 1 intervention
Trial outcomes
Primary outcomes
1
PWV
carotid-femoral pulse wave velocity measured by application tonometry
Time frame
6 months after COVID19 infection2
PWV
carotid-femoral pulse wave velocity measured by application tonometry
Time frame
12 months after COVID19 infection3
PWV change
carotid-femoral pulse wave velocity measured by application tonometry
Time frame
difference between PWV at 12 and 6 months after COVID19 infectionSecondary outcomes
1
arterial distensibility
carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound
Time frame
6 months after COVID19 infection2
arterial distensibility
carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound
Time frame
12 months after COVID19 infection3
arterial distensibility change
carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound
Time frame
difference between arterial distensibility at 12 and 6 months after COVID19 infection4
brachial artery FMD
brachial artery flow-mediated dilation for non-invasive evaluation of endothelial dysfunction, by ultrasound and automatic edge detection analysis
Time frame
6 months after COVID19 infectionOther outcomes
1
total mortality
individual data will be meta-analyzed with sister studies running in parallel worldwide
Time frame
2 years2
total mortality
individual data will be meta-analyzed with sister studies running in parallel worldwide
Time frame
5 years3
total mortality
individual data will be meta-analyzed with sister studies running in parallel worldwide
Time frame
10 years4
CV events
fatal+non-fatal
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
The Association for Research into Arterial Structure and Physiology
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
Source ClinicalTrials.gov