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

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06079424
Collaborator
(none)
7,500
Enrollment
162
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
7500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Risk Markers of Arterial Aging and Subsequent Risk of Cardiovascular Diseases and Beyond. The Paris Prospective Study III-2
Anticipated Study Start Date :
Jun 1, 2024
Anticipated Primary Completion Date :
Jun 1, 2027
Anticipated Study Completion Date :
Dec 1, 2037

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. carotid diameter [by 2027]

    high precision carotid echo tracking diameter in mm

  2. intima media thickness [by 2027]

    high precision echo tracking intima media thickness of the common carotid artery in mm

  3. carotid plaques [by 2027]

    high precision carotid echo tracking carotid plaques

  4. wall cross sectional area [by 2027]

    high precision carotid echo tracking carotid wall cross sectional area, mm2

  5. distensibility coefficient [by 2027]

    high precision carotid echo tracking distensibility coefficient in 10-3/kPa

  6. elastic modulus [by 2027]

    high precision carotid echo tracking Young's elastic modulus, 10-3*kPa

  7. pulse wave velocity [by 2027]

    high precision carotid echotracking pulse wave velocity, m/s

  8. carotid wall stress [by 2027]

    high precision carotid echotracking circumferential wall stress in kPa

  9. stiffness [by 2027]

    high precision carotid echotracking Beta stiffness index

  10. pulse pressure [by 2027]

    high precision carotid echotracking pulse pressure in mmHg

Secondary Outcome Measures

  1. brachial artery diameter [by 2027]

    ultra high frequency ultrasound radial artery diameter in mm

  2. thickness of the intima media of the radial artery [by 2027]

    ultra high frequency ultrasound radial artery intima media thickness in mm

  3. arterial plaques [by 2027]

    ultra high frequency ultrasound radial artery plaques

  4. wall cross sectional area of the radial artery [by 2027]

    ultra high frequency ultrasound radial artery wall cross sectional area, mm2

  5. distensibility of the radial artery [by 2027]

    ultra high frequency ultrasound radial artery distensibility coefficient in 10-3/kPa

  6. elastic modulus of the radial artery [by 2027]

    ultra high frequency ultrasound radial artery Young's elastic modulus, 10-3*kPa

  7. pulse wave velocity of the radial artery [by 2027]

    ultra high frequency ultrasound radial artery Pulse wave velocity, m/s

  8. stiffness index of the radial artery [by 2027]

    ultra high frequency ultrasound radial artery Beta stiffness index

  9. wall stress of the radial artery [by 2027]

    ultra high frequency ultrasound radial artery Circumferential wall stress, kPa

  10. pulse pressure of the radial artery [by 2027]

    ultra high frequency ultrasound radial artery Pulse Pressure, mmHg

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT06079424
Other Study ID Numbers:
  • C21-67
First Posted:
Oct 12, 2023
Last Update Posted:
Oct 12, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France
risk factors
cohort
cardiovascular diseases
Additional relevant MeSH terms:
Cardiovascular Diseases

Study Results

No Results Posted as of Oct 12, 2023