Advanced Approach to Arterial Stiffness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-01

Study Completion Date

2016-12-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Arterial Stiffness

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Cardio Ankle Vascular Index (CAVI) of the Vasera system VS1500N

CAVI will be measured using the Vasera device (VS1500 n - Fukuda Denshi co, Japan). This device is easy to use and calculates automatically the CAVI.

CAVI measurements will be performed according to the manufacturer Measurements will be performed after five to ten minute - period of rest in order to obtain a steady hemodynamic state and to limit measurements variability.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No