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

NCT04558450 | Recruiting

• 2 other identifiers: APHP20076220.07.24.57438
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 3

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.

Conditions

Covid19; Arterial Stiffness; Endothelial Dysfunction; Diastolic Dysfunction

Outcome Measures

Primary Outcomes (3)

• PWV

  carotid-femoral pulse wave velocity measured by application tonometry

  6 months after COVID19 infection

• PWV

  carotid-femoral pulse wave velocity measured by application tonometry

  12 months after COVID19 infection

• PWV change

  carotid-femoral pulse wave velocity measured by application tonometry

  difference between PWV at 12 and 6 months after COVID19 infection

Secondary Outcomes (19)

• arterial distensibility

  6 months after COVID19 infection

• arterial distensibility

  12 months after COVID19 infection

• arterial distensibility change

  difference between arterial distensibility at 12 and 6 months after COVID19 infection

• brachial artery FMD

  6 months after COVID19 infection

• brachial artery FMD

  12 months after COVID19 infection

Other Outcomes (6)

• total mortality

  2 years

• total mortality

  5 years

• total mortality

  10 years

Study Arms (4)

Group 1

OTHER

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

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

Diagnostic Test: carotid-femoral pulse-wave velocity

Group 3

OTHER

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

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

Diagnostic Test: carotid-femoral pulse-wave velocity

Interventions

carotid-femoral pulse-wave velocity DIAGNOSTIC_TEST

early vascular aging tests

Also known as: arterial distensibility, wave separation/intensity analysis, flow-mediated dilation, cardiac diastolic dysfunction, myocardial stiffness, central blood pressure

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• The Association for Research into Arterial Structure and Physiology: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (3)

CHRU Nancy

Nancy, 54500, France

RECRUITING

Hôpital Européen Georges Pompidou - APHP

Paris, 75015, France

RECRUITING

CHU Rouen

Rouen, 76031, France

RECRUITING

Related Links

• general description of the study
• summary and presentation of the global CARTESIAN initiative

MeSH Terms

Conditions

COVID-19

Interventions

Carotid-Femoral Pulse Wave Velocity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pulse Wave Analysis; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Pierre BOUTOUYRIE, MD PHD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosa Maria BRUNO, MD

CONTACT

+33 1 53 98 79 67; rosa-maria.bruno@inserm.fr

Laura LE MAO, MSc

CONTACT

+33 1 56 09 54 97; laura.le-mao@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 22, 2020
• Study Start: September 21, 2020
• Primary Completion: March 1, 2023
• Study Completion (Estimated): March 1, 2033
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: One year after the last publication
• 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.

Locations

FR (3)