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Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02318628
Study type Observational
Source International Society for Vascular Health
Contact
Status Completed
Phase N/A
Start date December 1, 2014
Completion date December 1, 2016

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