Risk Markers of Arterial Aging. The Paris Prospective Study III-2

Arterial Stiffness Clinical Trial

— PPS3-2  

Official title:

Risk Markers of Arterial Aging and Subsequent Risk of Cardiovascular Diseases and Beyond. The Paris Prospective Study III-2

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06079424
• Other study ID #: C21-67
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: December 2037

Study information

• Verified date: October 2023
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Jean-Philippe Empana, MD, PhD
• Phone: 33153988020
• Email: jean-philippe.empana[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objectives of PPS3-2 are (i) to describe the dynamics of vascular aging and baroreflex sensitivity 12 to 16 years a part, (ii) to identify their determinants, and (iii) to quantify the subsequent risk of cardiovascular diseases.

Description:

Since May 2008, PPS3 is being following the CVD morbidity of 10157 healthy volunteers aged 50-75 years at baseline. In PPS3-2, we plan to re-invite survivors and volunteers of PPS3 to undergo a second physical examination. In particular, they will undergo a second high-precision carotid echotracking to measure vascular aging parameters and baroreflex sensitivity, permitting to study their respective dynamics. They will also underwent for the first time ultra fast echo of the radial artery to measure vascular aging parameters of the medium-sized arteries. According to fundings, blood samples will be taken and stored at -80°C in the whole population or in a subsample.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 7500
• Est. completion date: December 2037
• Est. primary completion date: June 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

Inclusion Criteria:

• Being enrolled in PPS3 and having signed an informed consent for PPS3-2

Exclusion Criteria:

• Institutionalized participants

• Participants under guardianship

• Participants under judicial safeguard measure

Related Conditions & MeSH terms

• Arterial Stiffness
• Cardiovascular Diseases

Intervention

Other:
• high-precision carotid echo-tracking
evaluation of vascular aging parameters and baroreflex sensitivity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	carotid diameter	high precision carotid echo tracking diameter in mm	by 2027
Primary	intima media thickness	high precision echo tracking intima media thickness of the common carotid artery in mm	by 2027
Primary	carotid plaques	high precision carotid echo tracking carotid plaques	by 2027
Primary	wall cross sectional area	high precision carotid echo tracking carotid wall cross sectional area, mm2	by 2027
Primary	distensibility coefficient	high precision carotid echo tracking distensibility coefficient in 10-3/kPa	by 2027
Primary	elastic modulus	high precision carotid echo tracking Young's elastic modulus, 10-3*kPa	by 2027
Primary	pulse wave velocity	high precision carotid echotracking pulse wave velocity, m/s	by 2027
Primary	carotid wall stress	high precision carotid echotracking circumferential wall stress in kPa	by 2027
Primary	stiffness	high precision carotid echotracking Beta stiffness index	by 2027
Primary	pulse pressure	high precision carotid echotracking pulse pressure in mmHg	by 2027
Secondary	brachial artery diameter	ultra high frequency ultrasound radial artery diameter in mm	by 2027
Secondary	thickness of the intima media of the radial artery	ultra high frequency ultrasound radial artery intima media thickness in mm	by 2027
Secondary	arterial plaques	ultra high frequency ultrasound radial artery plaques	by 2027
Secondary	wall cross sectional area of the radial artery	ultra high frequency ultrasound radial artery wall cross sectional area, mm2	by 2027
Secondary	distensibility of the radial artery	ultra high frequency ultrasound radial artery distensibility coefficient in 10-3/kPa	by 2027
Secondary	elastic modulus of the radial artery	ultra high frequency ultrasound radial artery Young's elastic modulus, 10-3*kPa	by 2027
Secondary	pulse wave velocity of the radial artery	ultra high frequency ultrasound radial artery Pulse wave velocity, m/s	by 2027
Secondary	stiffness index of the radial artery	ultra high frequency ultrasound radial artery Beta stiffness index	by 2027
Secondary	wall stress of the radial artery	ultra high frequency ultrasound radial artery Circumferential wall stress, kPa	by 2027
Secondary	pulse pressure of the radial artery	ultra high frequency ultrasound radial artery Pulse Pressure, mmHg	by 2027