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

Primary Purpose

Covid19, Arterial Stiffness, Endothelial Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
carotid-femoral pulse-wave velocity
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHRU NancyRecruiting
  • Hôpital Européen Georges Pompidou - APHPRecruiting
  • CHU RouenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in intensive care unit

Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in a medicine unit

Patients with confirmed infection by SARS-Cov-2, not requiring hospitalization

4) individuals having performed a test for SARS-Cov-2 infection, but resulted to be negative

Outcomes

Primary Outcome Measures

PWV
carotid-femoral pulse wave velocity measured by application tonometry
PWV
carotid-femoral pulse wave velocity measured by application tonometry
PWV change
carotid-femoral pulse wave velocity measured by application tonometry

Secondary Outcome Measures

arterial distensibility
carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound
arterial distensibility
carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound
arterial distensibility change
carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound
brachial artery FMD
brachial artery flow-mediated dilation for non-invasive evaluation of endothelial dysfunction, by ultrasound and automatic edge detection analysis
brachial artery FMD
brachial artery flow-mediated dilation for non-invasive evaluation of endothelial dysfunction, by ultrasound and automatic edge detection analysis
brachial artery FMD change
brachial artery flow-mediated dilation for non-invasive evaluation of endothelial dysfunction, by ultrasound and automatic edge detection analysis
central blood pressure
central blood pressure obtained non-invasively by application tonometry and validated transfer function
central blood pressure
central blood pressure obtained non-invasively by application tonometry and validated transfer function
central blood pressure (BP) change
central blood pressure obtained non-invasively by application tonometry and validated transfer function
wave separation/wave intensity analysis (WSA/WIA)
peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk
wave separation/wave intensity analysis (WSA/WIA)
peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk
WSA/WIA change
peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk
cardiac diastolic dysfunction
E/e' at rest and after low-level exercise
cardiac diastolic dysfunction
E/e' at rest and after low-level exercise
cardiac diastolic dysfunction change
E/e' at rest and after low-level exercise
myocardial stiffness
cardioelastography by ultrafast ultrasound
myocardial stiffness
cardioelastography by ultrafast ultrasound
myocardial stiffness change
cardioelastography by ultrafast ultrasound
carotid femoral and hearth carotid change
Mesure by laser doppler vibrometry

Full Information

First Posted
August 31, 2020
Last Updated
November 15, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
The Association for Research into Arterial Structure and Physiology, Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT04558450
Brief Title
Covid-19 Effects on Arterial Stiffness and Vascular Aging (CARTESIAN)
Acronym
CARTESIAN
Official Title
Covid-19 Effects on ARTErial StIffness and Vascular AgiNg
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
The Association for Research into Arterial Structure and Physiology, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Arterial Stiffness, Endothelial Dysfunction, Diastolic Dysfunction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Other
Arm Description
Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in intensive care unit
Arm Title
Group 2
Arm Type
Other
Arm Description
Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in a medicine unit
Arm Title
Group 3
Arm Type
Other
Arm Description
Patients with confirmed infection by SARS-Cov-2, not requiring hospitalization
Arm Title
Group 4
Arm Type
Other
Arm Description
4) individuals having performed a test for SARS-Cov-2 infection, but resulted to be negative
Intervention Type
Diagnostic Test
Intervention Name(s)
carotid-femoral pulse-wave velocity
Other Intervention Name(s)
arterial distensibility, wave separation/intensity analysis, flow-mediated dilation, cardiac diastolic dysfunction, myocardial stiffness, central blood pressure
Intervention Description
early vascular aging tests
Primary Outcome Measure Information:
Title
PWV
Description
carotid-femoral pulse wave velocity measured by application tonometry
Time Frame
6 months after COVID19 infection
Title
PWV
Description
carotid-femoral pulse wave velocity measured by application tonometry
Time Frame
12 months after COVID19 infection
Title
PWV change
Description
carotid-femoral pulse wave velocity measured by application tonometry
Time Frame
difference between PWV at 12 and 6 months after COVID19 infection
Secondary Outcome Measure Information:
Title
arterial distensibility
Description
carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound
Time Frame
6 months after COVID19 infection
Title
arterial distensibility
Description
carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound
Time Frame
12 months after COVID19 infection
Title
arterial distensibility change
Description
carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound
Time Frame
difference between arterial distensibility at 12 and 6 months after COVID19 infection
Title
brachial artery FMD
Description
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 infection
Title
brachial artery FMD
Description
brachial artery flow-mediated dilation for non-invasive evaluation of endothelial dysfunction, by ultrasound and automatic edge detection analysis
Time Frame
12 months after COVID19 infection
Title
brachial artery FMD change
Description
brachial artery flow-mediated dilation for non-invasive evaluation of endothelial dysfunction, by ultrasound and automatic edge detection analysis
Time Frame
difference between FMD at 12 and 6 months after COVID19 infection
Title
central blood pressure
Description
central blood pressure obtained non-invasively by application tonometry and validated transfer function
Time Frame
6 months after COVID19 infection
Title
central blood pressure
Description
central blood pressure obtained non-invasively by application tonometry and validated transfer function
Time Frame
12 months after COVID19 infection
Title
central blood pressure (BP) change
Description
central blood pressure obtained non-invasively by application tonometry and validated transfer function
Time Frame
difference between central BP at 12 and 6 months after COVID19 infection
Title
wave separation/wave intensity analysis (WSA/WIA)
Description
peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk
Time Frame
6 months after COVID19 infection
Title
wave separation/wave intensity analysis (WSA/WIA)
Description
peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk
Time Frame
12 months after COVID19 infection
Title
WSA/WIA change
Description
peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk
Time Frame
difference between WSA/WIA at 12 and 6 months after COVID19 infection
Title
cardiac diastolic dysfunction
Description
E/e' at rest and after low-level exercise
Time Frame
6 months after COVID19 infection
Title
cardiac diastolic dysfunction
Description
E/e' at rest and after low-level exercise
Time Frame
12 months after COVID19 infection
Title
cardiac diastolic dysfunction change
Description
E/e' at rest and after low-level exercise
Time Frame
difference between cardiac diastolic dysfunction at 12 and 6 months after COVID19 infection
Title
myocardial stiffness
Description
cardioelastography by ultrafast ultrasound
Time Frame
6 months after COVID19 infection
Title
myocardial stiffness
Description
cardioelastography by ultrafast ultrasound
Time Frame
12 months after COVID19 infection
Title
myocardial stiffness change
Description
cardioelastography by ultrafast ultrasound
Time Frame
difference between myocardial stiffness at 12 and 6 months after COVID19 infection
Title
carotid femoral and hearth carotid change
Description
Mesure by laser doppler vibrometry
Time Frame
6 months after COVID19 infection
Other Pre-specified Outcome Measures:
Title
total mortality
Description
individual data will be meta-analyzed with sister studies running in parallel worldwide
Time Frame
2 years
Title
total mortality
Description
individual data will be meta-analyzed with sister studies running in parallel worldwide
Time Frame
5 years
Title
total mortality
Description
individual data will be meta-analyzed with sister studies running in parallel worldwide
Time Frame
10 years
Title
CV events
Description
fatal+non-fatal
Time Frame
2 years
Title
CV events
Description
fatal+non-fatal
Time Frame
5 years
Title
CV events
Description
fatal+non-fatal
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosa Maria BRUNO, MD
Phone
+33 1 53 98 79 67
Email
rosa-maria.bruno@inserm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laura LE MAO, MSc
Phone
+33 1 56 09 54 97
Email
laura.le-mao@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre BOUTOUYRIE, MD PHD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Nancy
City
Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athanase BENETOS, PhD
Phone
+ 33 3 83 15 33 22
Email
a.benetos@chru-nancy.fr
Facility Name
Hôpital Européen Georges Pompidou - APHP
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre BOUTOUYRIE, PUPH
Phone
+33 1 56 09 39 91
Email
Pierre.boutouyrie@aphp.fr
Facility Name
CHU Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérémy BELLIEN, PUPH
Phone
+33 2 32 88 14 28
Email
jeremy.bellien@chu.rouen.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
IPD Sharing Time Frame
One year after the last publication
IPD Sharing Access Criteria
Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and PI team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.
Links:
URL
http://www.arterysociety.org/our-activities-2/cartesian-2/
Description
general description of the study
URL
http://vascagenet.eu/successful-information-session-on-the-cartesian-study
Description
summary and presentation of the global CARTESIAN initiative

Learn more about this trial

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

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