Advanced Approach to Arterial Stiffness

NCT02318628 | Completed

• 1 other identifier: ISVH3A2013
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Arterial Stiffness

Keywords

Cardio ankle vascular index; CAVI; pulse wave velocity; PWV; Non invasive arterial structure assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pulse Wave Velocity

  2 years

• Blood pressure Measurements

  2 YEARS

Interventions

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

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.

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Society for Vascular Health: lead

Study Sites (1)

ISVH

Paris, 75016, France

Location

MeSH Terms

Interventions

Cardio Ankle Vascular Index

Intervention Hierarchy (Ancestors)

Pulse Wave Analysis; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• JIRAR TOPOUCHIAN

  ISVH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: December 17, 2014
• Study Start: December 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 5, 2018

Record last verified: 2018-02

Locations

FR (1)