Covid19CARTESIANNCT04558450
Covid-19 Effects on Arterial Stiffness and Vascular Aging (CARTESIAN)
A study testing carotid-femoral pulse-wave velocity in people with Covid19 and Arterial Stiffness, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
The purpose of the study is to evaluate the presence of early vascular aging 6 months and 12 months after COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Arterial Stiffness, Endothelial Dysfunction
- What is being tested?
- carotid-femoral pulse-wave velocity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 3 sitesFrance
- Study dates
- 21 Sep 2020to Mar 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CHRU Nancy
Nancy, 54500
Athanase BENETOS, PhD, + 33 3 83 15 33 22, a.benetos@chru-nancy.fr
- Recruiting
Hôpital Européen Georges Pompidou - APHP
Paris, 75015
Pierre BOUTOUYRIE, PUPH, +33 1 56 09 39 91, Pierre.boutouyrie@aphp.fr
- Recruiting
CHU Rouen
Rouen, 76031
Jérémy BELLIEN, PUPH, +33 2 32 88 14 28, jeremy.bellien@chu.rouen.fr
About this study
Official title: 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.
Read the 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
- Being tested
- carotid-femoral pulse-wave velocity
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid-femoral pulse-wave velocityDiagnostic test
Also called arterial distensibility, wave separation/intensity analysis, flow-mediated dilation, cardiac diastolic dysfunction
early vascular aging tests
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in intensive care unit Receives: Diagnostic Test: carotid-femoral pulse-wave velocity |
| Group 2 | Other | Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in a medicine unit Receives: Diagnostic Test: carotid-femoral pulse-wave velocity |
| Group 3 | Other | Patients with confirmed infection by SARS-Cov-2, not requiring hospitalization Receives: Diagnostic Test: carotid-femoral pulse-wave velocity |
| Group 4 | Other | 4) individuals having performed a test for SARS-Cov-2 infection, but resulted to be negative Receives: Diagnostic Test: carotid-femoral pulse-wave velocity |
What is being measured
The primary outcome is the main question the study is designed to answer.
PWV
carotid-femoral pulse wave velocity measured by application tonometry
Measured: 6 months after COVID19 infection
PWV
carotid-femoral pulse wave velocity measured by application tonometry
Measured: 12 months after COVID19 infection
PWV change
carotid-femoral pulse wave velocity measured by application tonometry
Measured: difference between PWV at 12 and 6 months after COVID19 infection
Secondary outcomes (19)
arterial distensibility
carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound
Measured: 6 months after COVID19 infection
arterial distensibility
carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound
Measured: 12 months after COVID19 infection
arterial distensibility change
carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months after COVID19 infection
central blood pressure
central blood pressure obtained non-invasively by application tonometry and validated transfer function
Measured: 12 months after COVID19 infection
central blood pressure (BP) change
central blood pressure obtained non-invasively by application tonometry and validated transfer function
Measured: 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
Measured: 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
Measured: 12 months after COVID19 infection
WSA/WIA change
peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk
Measured: difference between WSA/WIA at 12 and 6 months after COVID19 infection
cardiac diastolic dysfunction
E/e' at rest and after low-level exercise
Measured: 6 months after COVID19 infection
cardiac diastolic dysfunction
E/e' at rest and after low-level exercise
Measured: 12 months after COVID19 infection
cardiac diastolic dysfunction change
E/e' at rest and after low-level exercise
Measured: difference between cardiac diastolic dysfunction at 12 and 6 months after COVID19 infection
myocardial stiffness
cardioelastography by ultrafast ultrasound
Measured: 6 months after COVID19 infection
myocardial stiffness
cardioelastography by ultrafast ultrasound
Measured: 12 months after COVID19 infection
myocardial stiffness change
cardioelastography by ultrafast ultrasound
Measured: difference between myocardial stiffness at 12 and 6 months after COVID19 infection
carotid femoral and hearth carotid change
Mesure by laser doppler vibrometry
Measured: 6 months after COVID19 infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start21 Sep 2020
- Primary completionMar 2023 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- The Association for Research into Arterial Structure and Physiology, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Pierre BOUTOUYRIE, MD PHD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558450
- Sponsor's protocol ID
- APHP200762
- Other IDs
- APHP200762, 20.07.24.57438
- Acronym
- CARTESIAN
- Status last verified
- Nov 2021
- First submitted
- 31 Aug 2020
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 Effects on ARTErial StIffness and Vascular AgiNg
- ClinicalTrials.gov ID
- NCT04558450
- Acronym / sponsor ID
- CARTESIAN / APHP200762
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- The Association for Research into Arterial Structure and Physiology, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2033 (estimated)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Diagnostic Test: carotid-femoral pulse-wave velocityPatients with confirmed infection by SARS-Cov-2, requiring a hospitalization in intensive care unit |
| Group 2 | Other | Diagnostic Test: carotid-femoral pulse-wave velocityPatients with confirmed infection by SARS-Cov-2, requiring a hospitalization in a medicine unit |
| Group 3 | Other | Diagnostic Test: carotid-femoral pulse-wave velocityPatients with confirmed infection by SARS-Cov-2, not requiring hospitalization |
| Group 4 | Other | Diagnostic Test: carotid-femoral pulse-wave velocity4) individuals having performed a test for SARS-Cov-2 infection, but resulted to be negative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carotid-femoral pulse-wave velocityAlso: arterial distensibility, wave separation/intensity analysis, flow-mediated dilation, cardiac diastolic dysfunctionearly vascular aging tests | Diagnostic test | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
PWV
Time frame: 6 months after COVID19 infection
carotid-femoral pulse wave velocity measured by application tonometry
PWV
Time frame: 12 months after COVID19 infection
carotid-femoral pulse wave velocity measured by application tonometry
PWV change
Time frame: difference between PWV at 12 and 6 months after COVID19 infection
carotid-femoral pulse wave velocity measured by application tonometry
19 secondary outcomes
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
cardiac diastolic dysfunction
Time frame: 6 months after COVID19 infection
cardiac diastolic dysfunction
Time frame: 12 months after COVID19 infection
cardiac diastolic dysfunction change
Time frame: difference between cardiac diastolic dysfunction at 12 and 6 months after COVID19 infection
myocardial stiffness
Time frame: 6 months after COVID19 infection
myocardial stiffness
Time frame: 12 months after COVID19 infection
myocardial stiffness change
Time frame: difference between myocardial stiffness at 12 and 6 months after COVID19 infection
carotid femoral and hearth carotid change
Time frame: 6 months after COVID19 infection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- general description of the studyLink provided by the sponsor.
- summary and presentation of the global CARTESIAN initiativeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre BOUTOUYRIE, MD PHD principal investigator
Assistance Publique - Hôpitaux de Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carotid-femoral pulse-wave velocity in people with Covid19 and Arterial Stiffness, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosa Maria BRUNO, MD (+33 1 53 98 79 67, rosa-maria.bruno@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PWV (time frame: 6 months after COVID19 infection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.