Ignite Creation Date:
2024-05-06 @ 3:32 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02318628
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2014-12-12
Brief Title:
Advanced Approach to Arterial Stiffness
Sponsor:
International Society for Vascular Health
Organization:
International Society for Vascular Health
Study Overview
Official Title:
Advanced Approach to Arterial Stiffness AAA Study - Triple A Study
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AAA
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 ie 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 andor its different components
This is a multinational European prospective longitudinal study
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 ie 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 andor its different components
This is a multinational European prospective longitudinal study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None