NCT06079424

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,500

participants targeted

Target at P75+ for all trials

Timeline
92mo left

Started Jun 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Jun 2025Dec 2033

First Submitted

Initial submission to the registry

September 26, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 20, 2025

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2031

Expected
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2033

Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

5.9 years

First QC Date

September 26, 2023

Last Update Submit

September 4, 2025

Conditions

Keywords

risk factorscohortcardiovascular diseases

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (10)

  • brachial artery diameter

    by 2027

  • thickness of the intima media of the radial artery

    by 2027

  • arterial plaques

    by 2027

  • wall cross sectional area of the radial artery

    by 2027

  • distensibility of the radial artery

    by 2027

  • +5 more secondary outcomes

Study Arms (1)

Level of vascular aging

community-based prospective longitudinal cohort

Other: high-precision carotid echo-tracking

Interventions

evaluation of vascular aging parameters and baroreflex sensitivity

Level of vascular aging

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Institutionalized participants
  • Participants under guardianship
  • Participants under judicial safeguard measure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Précliniques

Paris, 75016, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA and citrate plasmatic samples

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Jean-Philippe Empana, MD, PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Philippe Empana, MD, PhD

CONTACT

Xavier Jouven, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 12, 2023

Study Start

June 20, 2025

Primary Completion (Estimated)

May 1, 2031

Study Completion (Estimated)

December 1, 2033

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations