NCT02318628

Advanced Approach to Arterial Stiffness

Advanced Approach to Arterial Stiffness (AAA Study - Triple A Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (actual)
• Sponsor: International Society for Vascular Health · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arterial Stiffness

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-06-01
• Completion: 2016-12-01
• First posted: 2014-12-17
• Last updated: 2018-02-05

Locations

1 site across 1 country: France