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

Covid19 Clinical Trial

— CARTESIAN  

Official title:

Covid-19 Effects on ARTErial StIffness and Vascular AgiNg

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04558450
• Other study ID #: APHP200762
• Secondary ID: APHP20076220.07.
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: March 2033

Study information

• Verified date: November 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Rosa Maria BRUNO, MD
• Phone: +33 1 53 98 79 67
• Email: rosa-maria.bruno[@]inserm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: March 2033
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Stiffness
• COVID-19
• Covid19
• Diastolic Dysfunction
• Endothelial Dysfunction

Intervention

Diagnostic Test:
• carotid-femoral pulse-wave velocity
early vascular aging tests

Locations

Country	Name	City	State
France	CHRU Nancy	Nancy
France	Hôpital Européen Georges Pompidou - APHP	Paris
France	CHU Rouen	Rouen

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France, The Association for Research into Arterial Structure and Physiology

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	total mortality	individual data will be meta-analyzed with sister studies running in parallel worldwide	2 years
Other	total mortality	individual data will be meta-analyzed with sister studies running in parallel worldwide	5 years
Other	total mortality	individual data will be meta-analyzed with sister studies running in parallel worldwide	10 years
Other	CV events	fatal+non-fatal	2 years
Other	CV events	fatal+non-fatal	5 years
Other	CV events	fatal+non-fatal	10 years
Primary	PWV	carotid-femoral pulse wave velocity measured by application tonometry	6 months after COVID19 infection
Primary	PWV	carotid-femoral pulse wave velocity measured by application tonometry	12 months after COVID19 infection
Primary	PWV change	carotid-femoral pulse wave velocity measured by application tonometry	difference between PWV at 12 and 6 months after COVID19 infection
Secondary	arterial distensibility	carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound	6 months after COVID19 infection
Secondary	arterial distensibility	carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound	12 months after COVID19 infection
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	central blood pressure	central blood pressure obtained non-invasively by application tonometry and validated transfer function	6 months after COVID19 infection
Secondary	central blood pressure	central blood pressure obtained non-invasively by application tonometry and validated transfer function	12 months after COVID19 infection
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	cardiac diastolic dysfunction	E/e' at rest and after low-level exercise	6 months after COVID19 infection
Secondary	cardiac diastolic dysfunction	E/e' at rest and after low-level exercise	12 months after COVID19 infection
Secondary	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
Secondary	myocardial stiffness	cardioelastography by ultrafast ultrasound	6 months after COVID19 infection
Secondary	myocardial stiffness	cardioelastography by ultrafast ultrasound	12 months after COVID19 infection
Secondary	myocardial stiffness change	cardioelastography by ultrafast ultrasound	difference between myocardial stiffness at 12 and 6 months after COVID19 infection
Secondary	carotid femoral and hearth carotid change	Mesure by laser doppler vibrometry	6 months after COVID19 infection

External Links

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