AgingEvolVOAgeNCT06742775
Evolution of the Relationship Between Central and Peripheral Arterial Wave Velocities as a Function of Age
An observational study of Aging and Diagnostic Techniques, Cardiovascular, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Acquisition of synchronized cardiovascular signals from non-invasive measurements (ECG, photoplethysmography pulse sensors, inductance plethysmography) in healthy volunteers aged from 18 to 75, during spontaneous ventilation with apneas (20 seconds) for a total acquisition time of 30 minutes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Diagnostic Techniques, Cardiovascular
- What is being tested?
- physiological signal acquisitions
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2025to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 60 healthy volunteers: 3 groups of 20 volunteers per age category (under 30, between 30 and 50, over 50)
Who may be able to join
- Men and women between 18 and 75 years of age
- No acute cardiovascular pathologies less than 2 years old,
- No chronic cardiovascular pathologies.
- Stature compatible with the use of the plethysmography T-shirt.
- Person affiliated to a social security scheme or beneficiary of such a scheme
- Signed informed consent form
Who cannot join
- Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of article L. 1121-8, persons admitted to a health or social establishment for purposes other than research, minors, persons under legal protection or unable to express their consent).
- Personnel with a hierarchical link to the principal investigator
- Subjects excluded from another study,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Laboratoire TIMC
Grenoble, 38000
Stéphane TANGUY, +33476637117, stephane.tanguy@univ-grenoble-alpes.fr
Julie Fontecave, +33456520063, julie.fontecave@univ-grenoble-alpes.fr
About this study
Acquisition of synchronized cardiovascular signals from non-invasive measurements (ECG, photoplethysmography pulse sensors, inductance plethysmography) in healthy volunteers aged from 18 to 75, during spontaneous ventilation with apneas (20 seconds) for a total acquisition time of 30 minutes.
- Conditions
- Aging, Diagnostic Techniques, Cardiovascular
- Being tested
- physiological signal acquisitions
- Keywords
- photoplethysmography, electrocardiography, inductive plethysmography, Pulse Wave Velocity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiological signal acquisitionsOther
Subjects will be fitted with non-intrusive devices. In a semi-recumbent position, they will be asked to perform
- 10 minutes of resting breathing
- 10 cycles consisting of a 20-second apnea, to be performed at the end of inspiration, and 1 minute 40 of breathing (100 seconds).
This single participation session will last a total of one hour for the volunteer (equipment, recording, de-equipping), including 30 minutes of acquisition.
| Study group | Role | What they receive |
|---|---|---|
| Under 30 | Healthy volunteers younger than 30 years Receives: Other: physiological signal acquisitions | |
| Between 30 and 50 | Healthy volunteers between 30 and 50 years Receives: Other: physiological signal acquisitions | |
| More than 50 | Healthy volunteers older than 50 years Receives: Other: physiological signal acquisitions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrocardiogram
acquisition of ECG signals
Measured: 1 hour
Photoplethysmography
acquisition of peripheral and central photoplethysmographic signals with radial, brachial, carotid and femoral sensors
Measured: 1 hour
inductive plethysmography
acquisition of abdominal and thoracic section variations with an inductive plethysmographic vest
Measured: 1 hour
Secondary outcomes (1)
link between peripheral and central pulse wave velocity
Assesment of the link between peripheral and central vascular function with statistical analysis (Linear regression, Bland and Altman test)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study startFeb 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps
- Responsible party
- Sponsor
- Investigators
- Stéphane TANGUY, Principal investigator, University Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742775
- Sponsor's protocol ID
- 38RC24.0299
- Acronym
- EvolVOAge
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diaz A, Galli C, Tringler M, Ramirez A, Cabrera Fischer EI. Reference values of pulse wave velocity in healthy people from an urban and rural argentinean population. Int J Hypertens. 2014;2014:653239. doi: 10.1155/2014/653239. Epub 2014 Aug 24.
PubMed 25215227Fontecave-Jallon J, Tanguy S. Inductive Plethysmography for aortic Pulse Wave Velocity. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul;2020:2711-2714. doi: 10.1109/EMBC44109.2020.9175329.
PubMed 33018566Fortier C, Agharazii M. Arterial Stiffness Gradient. Pulse (Basel). 2016 Apr;3(3-4):159-66. doi: 10.1159/000438852. Epub 2015 Sep 2.
PubMed 27195235Fortier C, Sidibe A, Desjardins MP, Marquis K, De Serres SA, Mac-Way F, Agharazii M. Aortic-Brachial Pulse Wave Velocity Ratio: A Blood Pressure-Independent Index of Vascular Aging. Hypertension. 2017 Jan;69(1):96-101. doi: 10.1161/HYPERTENSIONAHA.116.08409. Epub 2016 Nov 7.
PubMed 27821616Heffernan KS, Stoner L, London AS, Augustine JA, Lefferts WK. Estimated pulse wave velocity as a measure of vascular aging. PLoS One. 2023 Jan 26;18(1):e0280896. doi: 10.1371/journal.pone.0280896. eCollection 2023.
PubMed 36701358Yu S, McEniery CM. Central Versus Peripheral Artery Stiffening and Cardiovascular Risk. Arterioscler Thromb Vasc Biol. 2020 May;40(5):1028-1033. doi: 10.1161/ATVBAHA.120.313128. Epub 2020 Mar 19.
PubMed 32188277Weber T, Wassertheurer S, Hametner B, Parragh S, Eber B. Noninvasive methods to assess pulse wave velocity: comparison with the invasive gold standard and relationship with organ damage. J Hypertens. 2015 May;33(5):1023-31. doi: 10.1097/HJH.0000000000000518.
PubMed 25668350Wang J, Jing C, Hu X, Cui J, Tang Q, Tu L, Zhao S, Huang J, Guo D, Li Y, Xu J. Assessment of aortic to peripheral vascular stiffness and gradient by segmented upper limb PWV in healthy and hypertensive individuals. Sci Rep. 2023 Nov 13;13(1):19859. doi: 10.1038/s41598-023-46932-0.
PubMed 37963909Townsend RR, Wilkinson IB, Schiffrin EL, Avolio AP, Chirinos JA, Cockcroft JR, Heffernan KS, Lakatta EG, McEniery CM, Mitchell GF, Najjar SS, Nichols WW, Urbina EM, Weber T; American Heart Association Council on Hypertension. Recommendations for Improving and Standardizing Vascular Research on Arterial Stiffness: A Scientific Statement From the American Heart Association. Hypertension. 2015 Sep;66(3):698-722. doi: 10.1161/HYP.0000000000000033. Epub 2015 Jul 9. No abstract available.
PubMed 26160955Sztrymf B, Jacobs F, Chemla D, Richard C, Millasseau SC. Validation of the new Complior sensor to record pressure signals non-invasively. J Clin Monit Comput. 2013 Dec;27(6):613-9. doi: 10.1007/s10877-013-9477-y. Epub 2013 May 17.
PubMed 23681924Salvi P, Valbusa F, Kearney-Schwartz A, Labat C, Grillo A, Parati G, Benetos A. Non-Invasive Assessment of Arterial Stiffness: Pulse Wave Velocity, Pulse Wave Analysis and Carotid Cross-Sectional Distensibility: Comparison between Methods. J Clin Med. 2022 Apr 15;11(8):2225. doi: 10.3390/jcm11082225.
PubMed 35456316Salvi P, Lio G, Labat C, Ricci E, Pannier B, Benetos A. Validation of a new non-invasive portable tonometer for determining arterial pressure wave and pulse wave velocity: the PulsePen device. J Hypertens. 2004 Dec;22(12):2285-93. doi: 10.1097/00004872-200412000-00010.
PubMed 15614022Obeid H, Khettab H, Marais L, Hallab M, Laurent S, Boutouyrie P. Evaluation of arterial stiffness by finger-toe pulse wave velocity: optimization of signal processing and clinical validation. J Hypertens. 2017 Aug;35(8):1618-1625. doi: 10.1097/HJH.0000000000001371.
PubMed 28379892Karimpour P, May JM, Kyriacou PA. Photoplethysmography for the Assessment of Arterial Stiffness. Sensors (Basel). 2023 Dec 17;23(24):9882. doi: 10.3390/s23249882.
PubMed 38139728
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of the Relationship Between Central and Peripheral Arterial Wave Velocities as a Function of Age
- ClinicalTrials.gov ID
- NCT06742775
- Acronym / sponsor ID
- EvolVOAge / 38RC24.0299
- Conditions
- Aging, Diagnostic Techniques, Cardiovascular
- Keywords
- photoplethysmography, electrocardiography, inductive plethysmography, Pulse Wave Velocity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Grenoble Alps
- Study start
- Feb 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 19 Dec 2024 (actual)
- 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.
Acquisition of synchronized cardiovascular signals from non-invasive measurements (ECG, photoplethysmography pulse sensors, inductance plethysmography) in healthy volunteers aged from 18 to 75, during spontaneous ventilation with apneas (20 seconds) for a total acquisition time of 30 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Under 30 | – | Other: physiological signal acquisitionsHealthy volunteers younger than 30 years |
| Between 30 and 50 | – | Other: physiological signal acquisitionsHealthy volunteers between 30 and 50 years |
| More than 50 | – | Other: physiological signal acquisitionsHealthy volunteers older than 50 years |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 60 healthy volunteers: 3 groups of 20 volunteers per age category (under 30, between 30 and 50, over 50)
Key inclusion criteria (6 listed)
- Men and women between 18 and 75 years of age
- No acute cardiovascular pathologies less than 2 years old,
- No chronic cardiovascular pathologies.
- Stature compatible with the use of the plethysmography T-shirt.
- Person affiliated to a social security scheme or beneficiary of such a scheme
Key exclusion criteria (3 listed)
- Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of article L. 1121-8, persons admitted to a health or social establishment for purposes other than research, minors, persons under legal protection or unable to express their consent).
- Personnel with a hierarchical link to the principal investigator
- Subjects excluded from another study,
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 |
|---|---|---|
| physiological signal acquisitionsSubjects will be fitted with non-intrusive devices. In a semi-recumbent position, they will be asked to perform * 10 minutes of resting breathing * 10 cycles consisting of a 20-second apnea, to be performed at the end of inspiration, and 1 minute 40 of breathing (100 seconds). This single participation session will last a total of one hour for the volunteer (equipment, recording, de-equipping), including 30 minutes of acquisition. | Other | Between 30 and 50, More than 50, Under 30 |
Primary outcome
Electrocardiogram
Time frame: 1 hour
acquisition of ECG signals
Photoplethysmography
Time frame: 1 hour
acquisition of peripheral and central photoplethysmographic signals with radial, brachial, carotid and femoral sensors
inductive plethysmography
Time frame: 1 hour
acquisition of abdominal and thoracic section variations with an inductive plethysmographic vest
1 secondary outcome
link between peripheral and central pulse wave velocity
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Background: PubMed 25215227Diaz A, Galli C, Tringler M, Ramirez A, Cabrera Fischer EI. Reference values of pulse wave velocity in healthy people from an urban and rural argentinean population. Int J Hypertens. 2014;2014:653239. doi: 10.1155/2014/653239. Epub 2014 Aug 24.
- Background: PubMed 33018566Fontecave-Jallon J, Tanguy S. Inductive Plethysmography for aortic Pulse Wave Velocity. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul;2020:2711-2714. doi: 10.1109/EMBC44109.2020.9175329.
- Background: PubMed 27195235Fortier C, Agharazii M. Arterial Stiffness Gradient. Pulse (Basel). 2016 Apr;3(3-4):159-66. doi: 10.1159/000438852. Epub 2015 Sep 2.
- Background: PubMed 27821616Fortier C, Sidibe A, Desjardins MP, Marquis K, De Serres SA, Mac-Way F, Agharazii M. Aortic-Brachial Pulse Wave Velocity Ratio: A Blood Pressure-Independent Index of Vascular Aging. Hypertension. 2017 Jan;69(1):96-101. doi: 10.1161/HYPERTENSIONAHA.116.08409. Epub 2016 Nov 7.
- Background: PubMed 36701358Heffernan KS, Stoner L, London AS, Augustine JA, Lefferts WK. Estimated pulse wave velocity as a measure of vascular aging. PLoS One. 2023 Jan 26;18(1):e0280896. doi: 10.1371/journal.pone.0280896. eCollection 2023.
- Background: PubMed 32188277Yu S, McEniery CM. Central Versus Peripheral Artery Stiffening and Cardiovascular Risk. Arterioscler Thromb Vasc Biol. 2020 May;40(5):1028-1033. doi: 10.1161/ATVBAHA.120.313128. Epub 2020 Mar 19.
- Background: PubMed 25668350Weber T, Wassertheurer S, Hametner B, Parragh S, Eber B. Noninvasive methods to assess pulse wave velocity: comparison with the invasive gold standard and relationship with organ damage. J Hypertens. 2015 May;33(5):1023-31. doi: 10.1097/HJH.0000000000000518.
- Background: PubMed 37963909Wang J, Jing C, Hu X, Cui J, Tang Q, Tu L, Zhao S, Huang J, Guo D, Li Y, Xu J. Assessment of aortic to peripheral vascular stiffness and gradient by segmented upper limb PWV in healthy and hypertensive individuals. Sci Rep. 2023 Nov 13;13(1):19859. doi: 10.1038/s41598-023-46932-0.
- Background: PubMed 26160955Townsend RR, Wilkinson IB, Schiffrin EL, Avolio AP, Chirinos JA, Cockcroft JR, Heffernan KS, Lakatta EG, McEniery CM, Mitchell GF, Najjar SS, Nichols WW, Urbina EM, Weber T; American Heart Association Council on Hypertension. Recommendations for Improving and Standardizing Vascular Research on Arterial Stiffness: A Scientific Statement From the American Heart Association. Hypertension. 2015 Sep;66(3):698-722. doi: 10.1161/HYP.0000000000000033. Epub 2015 Jul 9. No abstract available.
- Background: PubMed 23681924Sztrymf B, Jacobs F, Chemla D, Richard C, Millasseau SC. Validation of the new Complior sensor to record pressure signals non-invasively. J Clin Monit Comput. 2013 Dec;27(6):613-9. doi: 10.1007/s10877-013-9477-y. Epub 2013 May 17.
- Background: PubMed 35456316Salvi P, Valbusa F, Kearney-Schwartz A, Labat C, Grillo A, Parati G, Benetos A. Non-Invasive Assessment of Arterial Stiffness: Pulse Wave Velocity, Pulse Wave Analysis and Carotid Cross-Sectional Distensibility: Comparison between Methods. J Clin Med. 2022 Apr 15;11(8):2225. doi: 10.3390/jcm11082225.
- Background: PubMed 15614022Salvi P, Lio G, Labat C, Ricci E, Pannier B, Benetos A. Validation of a new non-invasive portable tonometer for determining arterial pressure wave and pulse wave velocity: the PulsePen device. J Hypertens. 2004 Dec;22(12):2285-93. doi: 10.1097/00004872-200412000-00010.
- Individual participant dataSharing planned: No
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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.
Stéphane TANGUY principal investigator
University Grenoble Alpes
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 Aging and Diagnostic Techniques, Cardiovascular, run by University Hospital, Grenoble 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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 19 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphane TANGUY (+33476637117, stephane.tanguy@univ-grenoble-alpes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrocardiogram (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06742775, which also lists 14 linked publications.
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 19 Dec 2024.