Risk Markers of Arterial Aging. The Paris Prospective Study III-2 (PPS3-2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Arterial Stiffness
• Intervention / Treatment: Other: high-precision carotid echo-tracking

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 7500

Contacts and Locations

• Study Contact: Name: Jean-Philippe Empana, MD, PhD; Phone Number: 33153988020; Email: jean-philippe.empana@inserm.fr
• Study Contact Backup: Name: Xavier Jouven, MD, PhD; Email: xavier.jouven@inserm.fr

Study Locations

• France
  • Paris, France, 75016
    • Recruiting
    • Centre d'Investigation Précliniques
    • Contact: Nicolas Danchin; Phone Number: 0153673535; Email: nicolas.danchin@egp.aphp.fr
    • Contact: Jean-Philippe Empana; Email: jean-philippe.empana@inserm.fr
    • Principal Investigator: Jean-Philippe Empana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Men and women aged 60 to 95 years who are participants of the PPS3 study and have accepted to undergo a second physical examination and answer to health questionnaires in primary care health centre in Paris that is subsidized by the French Health Insurance System.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Level of vascular aging; community-based prospective longitudinal cohort	Other: high-precision carotid echo-tracking; evaluation of vascular aging parameters and baroreflex sensitivity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
carotid diameter	high precision carotid echo tracking diameter in mm	by 2027
intima media thickness	high precision echo tracking intima media thickness of the common carotid artery in mm	by 2027
carotid plaques	high precision carotid echo tracking carotid plaques	by 2027
wall cross sectional area	high precision carotid echo tracking carotid wall cross sectional area, mm2	by 2027
distensibility coefficient	high precision carotid echo tracking distensibility coefficient in 10-3/kPa	by 2027
elastic modulus	high precision carotid echo tracking Young's elastic modulus, 10-3*kPa	by 2027
pulse wave velocity	high precision carotid echotracking pulse wave velocity, m/s	by 2027
carotid wall stress	high precision carotid echotracking circumferential wall stress in kPa	by 2027
stiffness	high precision carotid echotracking Beta stiffness index	by 2027
pulse pressure	high precision carotid echotracking pulse pressure in mmHg	by 2027

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
brachial artery diameter	ultra high frequency ultrasound radial artery diameter in mm	by 2027
thickness of the intima media of the radial artery	ultra high frequency ultrasound radial artery intima media thickness in mm	by 2027
arterial plaques	ultra high frequency ultrasound radial artery plaques	by 2027
wall cross sectional area of the radial artery	ultra high frequency ultrasound radial artery wall cross sectional area, mm2	by 2027
distensibility of the radial artery	ultra high frequency ultrasound radial artery distensibility coefficient in 10-3/kPa	by 2027
elastic modulus of the radial artery	ultra high frequency ultrasound radial artery Young's elastic modulus, 10-3*kPa	by 2027
pulse wave velocity of the radial artery	ultra high frequency ultrasound radial artery Pulse wave velocity, m/s	by 2027
stiffness index of the radial artery	ultra high frequency ultrasound radial artery Beta stiffness index	by 2027
wall stress of the radial artery	ultra high frequency ultrasound radial artery Circumferential wall stress, kPa	by 2027
pulse pressure of the radial artery	ultra high frequency ultrasound radial artery Pulse Pressure, mmHg	by 2027

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Jean-Philippe Empana, MD, PhD, Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2025
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): December 1, 2033

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: risk factors; cardiovascular diseases; cohort
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: C21-67

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No