Clinical trial NCT02318628: Advanced Approach to Arterial Stiffness
Official title: Advanced Approach to Arterial Stiffness (AAA Study - Triple A Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Stiffness
Keywords: Cardio ankle vascular index
CAVI
pulse wave velocity
PWV
Non invasive arterial structure assessment
Lead sponsor: International Society for Vascular Health
Sponsor class: OTHER
First posted: 2014-12-17
Enrollment: 2000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged 40-85 with life expectancy over 2 years will be included. Patients will be stratified according to their age (3 groups: 40-54, 55-69, 70-85 years)) and the presence or not of MetS.

Brief summary: The aim of the 3A Study is to assess the role of MetS on the arterial mechanics and vascular health in different age groups using the Cardio Ankle Vascular Index (CAVI) of the Vasera system and the "classic" carotid-femoral Pulse Wave Velocity (PWV).

Detailed description: Hypothesis The aim of thie 3A study is to assess the role of MetS on the arterial mechanics and vascular health in different age groups using the Cardio Ankle Vascular Index (CAVI) of the Vasera system and the "classic" carotid-femoral Pulse Wave Velocity (PWV).

STUDY OBJECTIVES

1. Objectives Primary Objective: Assess the influence of MetS on CAVI values (primary study endpoint) in 3 different age groups (40-54, 55-69, 70-85 years) of a European population.
2. Secondary Objectives

   * Establish the CAVI values in a European population according to the clusters of (MetS) components i.e. cardiovascular risk factors: abdominal obesity, high triglycerides, low HDL cholesterol, elevated blood pressure (BP), systolic or diastolic, and elevated fasting glucose (and diabetes), as well as tobacco smoking.
   * Assess the correlation between CAVI and the carotid-femoral PWV in the full population and in each age group; and compare the impact of MetS and its components on both the CAVI and PWV
   * To establish, the relationship between cardiovascular risk factors and the evolution of arterial stiffness as evaluated by CAVI and carotid-femoral PWV over a 2-year follow-up period.
   * To assess changes and predictive value of CAVI on organ damages and CV events during the follow-up period.
   * To assess 24h ABPM and its correlations and variations with the CAVI and PWV in patients with MetS and/or its different components.

This is a multinational European prospective longitudinal study.

Eligibility criteria: Inclusion Criteria:

* All patients aged 40-85 with life expectancy over 2 years will be included. Patients will be stratified according to their age (3 groups: 40-54, 55-69, 70-85 years)) and the presence or not of MetS.

Exclusion Criteria:

* Factors that may impair the quality of the CAVI and /or the PWV measurement or make PWV recording unreliable: known significant peripheral vascular disease with proximal artery stenosis, ankle brachial index \< 0.9, or limb amputation; history of vascular surgery at the level of the carotid artery, femoral artery or aorta; body mass index \> 40 kg/m²; atrial fibrillation and/or other major arrhythmia.

Primary outcomes:
measure: Cardio-Ankle-Vascular Index
timeFrame: 2 years
Secondary outcomes:
measure: Pulse Wave Velocity
timeFrame: 2 years
measure: Blood pressure Measurements
timeFrame: 2 YEARS
Other outcomes:
Locations:
city: Paris
country: France
facility: ISVH
Study officials:
affiliation: ISVH
name: JIRAR TOPOUCHIAN
role: STUDY_DIRECTOR
References: