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| ID | Type | Description | Link |
|---|---|---|---|
| APHP200762 | Other Identifier | ANSM | |
| 20.07.24.57438 | Other Identifier | CNRIPH |
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| Name | Class |
|---|---|
| The Association for Research into Arterial Structure and Physiology | UNKNOWN |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in intensive care unit |
|
| Group 2 | Other | Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in a medicine unit |
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| Group 3 | Other | Patients with confirmed infection by SARS-Cov-2, not requiring hospitalization |
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| Group 4 | Other | 4) individuals having performed a test for SARS-Cov-2 infection, but resulted to be negative |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carotid-femoral pulse-wave velocity | Diagnostic Test | early vascular aging tests |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| arterial distensibility | carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound | 6 months after COVID19 infection |
| arterial distensibility | carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound |
| Measure | Description | Time Frame |
|---|---|---|
| total mortality | individual data will be meta-analyzed with sister studies running in parallel worldwide | 2 years |
| total mortality | individual data will be meta-analyzed with sister studies running in parallel worldwide |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Pierre BOUTOUYRIE, MD PHD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Nancy | Recruiting | Nancy | 54500 | France |
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| Label | URL |
|---|---|
| general description of the study | View source |
| summary and presentation of the global CARTESIAN initiative | View source |
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Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
One year after the last publication
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.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000080909 | Carotid-Femoral Pulse Wave Velocity |
| ID | Term |
|---|---|
| D063177 | Pulse Wave Analysis |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Prospective cohort study
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| 12 months after COVID19 infection |
| arterial distensibility change | carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound | 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 | 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 | 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 | 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 | 6 months after COVID19 infection |
| central blood pressure | central blood pressure obtained non-invasively by application tonometry and validated transfer function | 12 months after COVID19 infection |
| central blood pressure (BP) change | central blood pressure obtained non-invasively by application tonometry and validated transfer function | 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 | 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 | 12 months after COVID19 infection |
| WSA/WIA change | peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk | difference between WSA/WIA at 12 and 6 months after COVID19 infection |
| cardiac diastolic dysfunction | E/e' at rest and after low-level exercise | 6 months after COVID19 infection |
| cardiac diastolic dysfunction | E/e' at rest and after low-level exercise | 12 months after COVID19 infection |
| cardiac diastolic dysfunction change | E/e' at rest and after low-level exercise | difference between cardiac diastolic dysfunction at 12 and 6 months after COVID19 infection |
| myocardial stiffness | cardioelastography by ultrafast ultrasound | 6 months after COVID19 infection |
| myocardial stiffness | cardioelastography by ultrafast ultrasound | 12 months after COVID19 infection |
| myocardial stiffness change | cardioelastography by ultrafast ultrasound | difference between myocardial stiffness at 12 and 6 months after COVID19 infection |
| carotid femoral and hearth carotid change | Mesure by laser doppler vibrometry | 6 months after COVID19 infection |
| 5 years |
| total mortality | individual data will be meta-analyzed with sister studies running in parallel worldwide | 10 years |
| CV events | fatal+non-fatal | 2 years |
| CV events | fatal+non-fatal | 5 years |
| CV events | fatal+non-fatal | 10 years |
| Hôpital Européen Georges Pompidou - APHP | Recruiting | Paris | 75015 | France |
|
| CHU Rouen | Recruiting | Rouen | 76031 | France |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |