Clinical trial NCT06079424: Risk Markers of Arterial Aging. The Paris Prospective Study III-2
Official title: Risk Markers of Arterial Aging and Subsequent Risk of Cardiovascular Diseases and Beyond. The Paris Prospective Study III-2
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Arterial Stiffness
Keywords: risk factors
cohort
cardiovascular diseases
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2023-10-12
Enrollment: 7500
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: carotid diameter
timeFrame: by 2027
measure: intima media thickness
timeFrame: by 2027
measure: carotid plaques
timeFrame: by 2027
measure: wall cross sectional area
timeFrame: by 2027
measure: distensibility coefficient
timeFrame: by 2027
measure: elastic modulus
timeFrame: by 2027
measure: pulse wave velocity
timeFrame: by 2027
measure: carotid wall stress
timeFrame: by 2027
measure: stiffness
timeFrame: by 2027
measure: pulse pressure
timeFrame: by 2027
Secondary outcomes:
measure: brachial artery diameter
timeFrame: by 2027
measure: thickness of the intima media of the radial artery
timeFrame: by 2027
measure: arterial plaques
timeFrame: by 2027
measure: wall cross sectional area of the radial artery
timeFrame: by 2027
measure: distensibility of the radial artery
timeFrame: by 2027
measure: elastic modulus of the radial artery
timeFrame: by 2027
measure: pulse wave velocity of the radial artery
timeFrame: by 2027
measure: stiffness index of the radial artery
timeFrame: by 2027
measure: wall stress of the radial artery
timeFrame: by 2027
measure: pulse pressure of the radial artery
timeFrame: by 2027
Other outcomes:
Locations:
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Jean-Philippe Empana, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: