Arterial StiffnessAAANCT02318628
Advanced Approach to Arterial Stiffness
An observational study of Arterial Stiffness, run by International Society for Vascular Health at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Arterial Stiffness
- What is being tested?
- Cardio Ankle Vascular Index (CAVI) of the Vasera system VS1500N
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2014to 1 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advanced Approach to Arterial Stiffness (AAA Study - Triple A Study)
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).
Read the 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
- 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.
- 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
- Being tested
- Cardio Ankle Vascular Index (CAVI) of the Vasera system VS1500N
- Keywords
- Cardio ankle vascular index, CAVI, pulse wave velocity, PWV, Non invasive arterial structure assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardio Ankle Vascular Index (CAVI) of the Vasera system VS1500NDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
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.
Measured: 2 years
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.
Measured: 2 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study start1 Dec 2014
- Primary completion1 Jun 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial StiffnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Society for Vascular Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JIRAR TOPOUCHIAN, Study director, ISVH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318628
- Sponsor's protocol ID
- ISVH3A2013
- Acronym
- AAA
- Status last verified
- Feb 2018
- First submitted
- 12 Dec 2014
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Approach to Arterial Stiffness (AAA Study - Triple A Study)
- ClinicalTrials.gov ID
- NCT02318628
- Acronym / sponsor ID
- AAA / ISVH3A2013
- Conditions
- Arterial Stiffness
- Keywords
- Cardio ankle vascular index, CAVI, pulse wave velocity, PWV, Non invasive arterial structure assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- International Society for Vascular HealthUniversity, hospital or other
- Study start
- 1 Dec 2014
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 17 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardio Ankle Vascular Index (CAVI) of the Vasera system VS1500NCAVI 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. | Device | – |
Primary outcome
Cardio-Ankle-Vascular Index
Time frame: 2 years
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 secondary outcomes
Pulse Wave Velocity
Time frame: 2 years
Blood pressure Measurements
Time frame: 2 YEARS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JIRAR TOPOUCHIAN study director
ISVH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Stiffness, run by International Society for Vascular Health at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardio-Ankle-Vascular Index (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.