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

NCT ID: NCT04558450

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2033-03-31

Brief Summary

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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

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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

Conditions

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Covid19 Arterial Stiffness Endothelial Dysfunction Diastolic Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Prospective cohort study
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group 1

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

Group Type OTHER

carotid-femoral pulse-wave velocity

Intervention Type DIAGNOSTIC_TEST

early vascular aging tests

Group 2

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

Group Type OTHER

carotid-femoral pulse-wave velocity

Intervention Type DIAGNOSTIC_TEST

early vascular aging tests

Group 3

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

Group Type OTHER

carotid-femoral pulse-wave velocity

Intervention Type DIAGNOSTIC_TEST

early vascular aging tests

Group 4

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

Group Type OTHER

carotid-femoral pulse-wave velocity

Intervention Type DIAGNOSTIC_TEST

early vascular aging tests

Interventions

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carotid-femoral pulse-wave velocity

early vascular aging tests

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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arterial distensibility wave separation/intensity analysis flow-mediated dilation cardiac diastolic dysfunction myocardial stiffness central blood pressure

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Association for Research into Arterial Structure and Physiology

UNKNOWN

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre BOUTOUYRIE, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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CHRU Nancy

Nancy, , France

Site Status RECRUITING

Hôpital Européen Georges Pompidou - APHP

Paris, , France

Site Status RECRUITING

CHU Rouen

Rouen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Rosa Maria BRUNO, MD

Role: CONTACT

Phone: +33 1 53 98 79 67

Email: [email protected]

Laura LE MAO, MSc

Role: CONTACT

Phone: +33 1 56 09 54 97

Email: [email protected]

Facility Contacts

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Athanase BENETOS, PhD

Role: primary

Pierre BOUTOUYRIE, PUPH

Role: primary

Jérémy BELLIEN, PUPH

Role: primary

Related Links

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http://vascagenet.eu/successful-information-session-on-the-cartesian-study

summary and presentation of the global CARTESIAN initiative

Other Identifiers

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APHP200762

Identifier Type: OTHER

Identifier Source: secondary_id

20.07.24.57438

Identifier Type: OTHER

Identifier Source: secondary_id

APHP200762

Identifier Type: -

Identifier Source: org_study_id