Advanced Approach to Arterial Stiffness

Arterial Stiffness Clinical Trial

— AAA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318628
• Other study ID #: ISVH3A2013
• Status: Completed
• Phase: N/A
• First received: December 12, 2014
• Last updated: February 2, 2018
• Start date: December 1, 2014
• Est. completion date: December 1, 2016

Study information

• Verified date: February 2018
• Source: International Society for Vascular Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: December 1, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Stiffness

Intervention

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.

Locations

Country	Name	City	State
France	ISVH	Paris

Sponsors (1)

Lead Sponsor	Collaborator
International Society for Vascular Health

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardio-Ankle-Vascular Index	CAVI will be measured using the Vasera device (Fukuda Denshi co, Japan). This device is easy to use and calculates automatically the CAVI.; CAVI measurements will be performed according to the manufacturer recommendations 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.; The details of the CAVI measurements are shown in a specific document, C.F. appendix; Ankle Brachial Index (ABI): The Ankle Brachial Index (ABI) will be measured using the Vasera device (Fukuda Denshi co, Japan). This device will calculate the ABI automatically.; ABI measurements will be performed according to the manufacturer recommendations 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.	2 years
Secondary	Pulse Wave Velocity	Measurement of PWV will be performed using a validated automatic device (Complior®, Sphygmocor®, and PulsePen®). The method of "simultaneous" recordings of the pulse waves from 2 different sites (carotid and femoral arteries) will be preferred. Because of the use of several devices, normalisation of the measurement values will be performed according to the European Experts recommendations.	2 years
Secondary	Blood pressure Measurements	Blood pressure will be measured in clinic according to the European Society of Hypertension (ESH) guidelines. BP should be measured in a standardized fashion using equipment that meets certification criteria.	2 YEARS