Aortic Pulse Wave VelocityNCT05400421
Validation of Optical Device for Aortic Pulse Wave Velocity Measurement
An observational study of Aortic Pulse Wave Velocity, run by VitalSines International Inc..
Trial summary
Existing techniques available for capturing reliable aortic pulse wave velocity measurements and estimating aortic stiffness are costly and require technical expertise. The purpose of this research is to investigate an oximeter device performance as a stand-alone aortic pulse wave velocity (PWV) measurement… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Pulse Wave Velocity
- What is being tested?
- System & Method for Monitoring Aortic Pulse Wave Velocity & Blood Pressure
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Jul 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic patients with a health cardiovascular background.
Who may be able to join
- -
Who cannot join
- History of cardiovascular disease
- Not in sinus rhythm/arrhythmia
- Pacemaker
- Impalpable arterial pulse
- Use of blood pressure medication
- Systolic blood pressure > 140
Show all 12Show fewer
- Use of vasoactive medication
- Use of cholesterol medication
- Diabetes diagnosis
- Smokers
- BMI > 30 kg/m2
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Validation of Photoplethysmography Device for the Measurement of Aortic Pulse Wave Velocity Against Carotid-Femoral Values From Piezoelectric Sensors
Existing techniques available for capturing reliable aortic pulse wave velocity measurements and estimating aortic stiffness are costly and require technical expertise. The purpose of this research is to investigate an oximeter device performance as a stand-alone aortic pulse wave velocity (PWV) measurement instrument. By validating this device and its measurements against the gold-standard method of carotid-femoral readings, we aim to demonstrate that the proposed method is an comparably effective in terms of the metrics (Mean difference, standard deviation, correlation, etc.) outlined by the Artery Society Guidelines.
- Conditions
- Aortic Pulse Wave Velocity
- Being tested
- System & Method for Monitoring Aortic Pulse Wave Velocity & Blood Pressure
- Keywords
- aortic pulse wave velocity, plethysmography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
System & Method for Monitoring Aortic Pulse Wave Velocity & Blood PressureDevice
Carotid-femoral aortic pulse wave velocity will be compared against values collected from the oximeter system. The former is assessed by placing piezoelectric pressure sensors at three locations: the right common carotid artery, the right common femoral artery (groin), and the right superficial femoral artery (thigh). The oximeter will be secured on the right index finger. Simultaneous data collection will occur for both methods, with each trail lasting 60 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Device Calibration & Algorithm Training | The data obtained from this group will be used to a) quantify the relationship between PWV measured at the groin versus the thigh for less intrusive future piezo sensor placement and b) train the proposed device for the next cohort. Receives: Device: System & Method for Monitoring Aortic Pulse Wave Velocity & Blood Pressure | |
| Device & Algorithm Testing | The gold-standard and new device values will be collected from this group to validate the previously trained system. Receives: Device: System & Method for Monitoring Aortic Pulse Wave Velocity & Blood Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic Pulse Wave Velocity
The speed at which a single pulse/heart beat propagates down the aorta.
Measured: 6 measurements per subject, each lasting 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Aortic Pulse Wave VelocityStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VitalSines International Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jess Goodman, M.D., Principal investigator, VitalSines International Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400421
- Sponsor's protocol ID
- OBA-MAPWV
- Status last verified
- Jun 2022
- First submitted
- 27 May 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Safar ME, Levy BI, Struijker-Boudier H. Current perspectives on arterial stiffness and pulse pressure in hypertension and cardiovascular diseases. Circulation. 2003 Jun 10;107(22):2864-9. doi: 10.1161/01.CIR.0000069826.36125.B4. No abstract available.
PubMed 12796414Laurent S, Katsahian S, Fassot C, Tropeano AI, Gautier I, Laloux B, Boutouyrie P. Aortic stiffness is an independent predictor of fatal stroke in essential hypertension. Stroke. 2003 May;34(5):1203-6. doi: 10.1161/01.STR.0000065428.03209.64. Epub 2003 Apr 3.
PubMed 12677025Van Bortel LM, Laurent S, Boutouyrie P, Chowienczyk P, Cruickshank JK, De Backer T, Filipovsky J, Huybrechts S, Mattace-Raso FU, Protogerou AD, Schillaci G, Segers P, Vermeersch S, Weber T; Artery Society; European Society of Hypertension Working Group on Vascular Structure and Function; European Network for Noninvasive Investigation of Large Arteries. Expert consensus document on the measurement of aortic stiffness in daily practice using carotid-femoral pulse wave velocity. J Hypertens. 2012 Mar;30(3):445-8. doi: 10.1097/HJH.0b013e32834fa8b0.
PubMed 22278144Xu SK, Hong XF, Cheng YB, Liu CY, Li Y, Yin B, Wang JG. Validation of a Piezoelectric Sensor Array-Based Device for Measurement of Carotid-Femoral Pulse Wave Velocity: The Philips Prototype. Pulse (Basel). 2018 Mar;5(1-4):161-168. doi: 10.1159/000486317. Epub 2018 Feb 8.
PubMed 29761092Kelly R, Hayward C, Avolio A, O'Rourke M. Noninvasive determination of age-related changes in the human arterial pulse. Circulation. 1989 Dec;80(6):1652-9. doi: 10.1161/01.cir.80.6.1652.
PubMed 2598428Chirinos JA, Segers P, Duprez DA, Brumback L, Bluemke DA, Zamani P, Kronmal R, Vaidya D, Ouyang P, Townsend RR, Jacobs DR Jr. Late systolic central hypertension as a predictor of incident heart failure: the Multi-ethnic Study of Atherosclerosis. J Am Heart Assoc. 2015 Mar 3;4(3):e001335. doi: 10.1161/JAHA.114.001335.
PubMed 25736440Ding FH, Fan WX, Zhang RY, Zhang Q, Li Y, Wang JG. Validation of the noninvasive assessment of central blood pressure by the SphygmoCor and Omron devices against the invasive catheter measurement. Am J Hypertens. 2011 Dec;24(12):1306-11. doi: 10.1038/ajh.2011.145. Epub 2011 Oct 6.
PubMed 21976274Pereira T, Maldonado J, Coutinho R, Cardoso E, Laranjeiro M, Andrade I, Conde J. Invasive validation of the Complior Analyse in the assessment of central artery pressure curves: a methodological study. Blood Press Monit. 2014 Oct;19(5):280-7. doi: 10.1097/MBP.0000000000000058.
PubMed 24892879Wang TW, Lin SF. Wearable Piezoelectric-Based System for Continuous Beat-to-Beat Blood Pressure Measurement. Sensors (Basel). 2020 Feb 5;20(3):851. doi: 10.3390/s20030851.
PubMed 32033495Park J, Seok HS, Kim SS, Shin H. Photoplethysmogram Analysis and Applications: An Integrative Review. Front Physiol. 2022 Mar 1;12:808451. doi: 10.3389/fphys.2021.808451. eCollection 2021.
PubMed 35300400I.B. Wilkinson, C.M. McEniery, G. Schillaci, P. Boutouyrie, P. Segers, A. Donald, et al. ARTERY Society guidelines for validation of non-invasive haemodynamic measurement devices: part 1, arterial pulse wave velocity Artery Res, 4 (2) (2010), p. 34
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Photoplethysmography Device for the Measurement of Aortic Pulse Wave Velocity Against Carotid-Femoral Values From Piezoelectric Sensors
- ClinicalTrials.gov ID
- NCT05400421
- Acronym / sponsor ID
- OBA-MAPWV
- Conditions
- Aortic Pulse Wave Velocity
- Keywords
- aortic pulse wave velocity, plethysmography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- VitalSines International Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 1 Jun 2022 (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.
Existing techniques available for capturing reliable aortic pulse wave velocity measurements and estimating aortic stiffness are costly and require technical expertise. The purpose of this research is to investigate an oximeter device performance as a stand-alone aortic pulse wave velocity (PWV) measurement instrument. By validating this device and its measurements against the gold-standard method of carotid-femoral readings, we aim to demonstrate that the proposed method is an comparably effective in terms of the metrics (Mean difference, standard deviation, correlation, etc.) outlined by the Artery Society Guidelines.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device Calibration & Algorithm Training | – | Device: System & Method for Monitoring Aortic Pulse Wave Velocity & Blood PressureThe data obtained from this group will be used to a) quantify the relationship between PWV measured at the groin versus the thigh for less intrusive future piezo sensor placement and b) train the proposed device for the next cohort. |
| Device & Algorithm Testing | – | Device: System & Method for Monitoring Aortic Pulse Wave Velocity & Blood PressureThe gold-standard and new device values will be collected from this group to validate the previously trained system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic patients with a health cardiovascular background.
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (12 listed)
- History of cardiovascular disease
- Not in sinus rhythm/arrhythmia
- Pacemaker
- Impalpable arterial pulse
- Use of blood pressure medication
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 |
|---|---|---|
| System & Method for Monitoring Aortic Pulse Wave Velocity & Blood PressureCarotid-femoral aortic pulse wave velocity will be compared against values collected from the oximeter system. The former is assessed by placing piezoelectric pressure sensors at three locations: the right common carotid artery, the right common femoral artery (groin), and the right superficial femoral artery (thigh). The oximeter will be secured on the right index finger. Simultaneous data collection will occur for both methods, with each trail lasting 60 seconds. | Device | Device & Algorithm Testing, Device Calibration & Algorithm Training |
Primary outcome
Aortic Pulse Wave Velocity
Time frame: 6 measurements per subject, each lasting 60 seconds
The speed at which a single pulse/heart beat propagates down the aorta.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Background: PubMed 12796414Safar ME, Levy BI, Struijker-Boudier H. Current perspectives on arterial stiffness and pulse pressure in hypertension and cardiovascular diseases. Circulation. 2003 Jun 10;107(22):2864-9. doi: 10.1161/01.CIR.0000069826.36125.B4. No abstract available.
- Background: PubMed 12677025Laurent S, Katsahian S, Fassot C, Tropeano AI, Gautier I, Laloux B, Boutouyrie P. Aortic stiffness is an independent predictor of fatal stroke in essential hypertension. Stroke. 2003 May;34(5):1203-6. doi: 10.1161/01.STR.0000065428.03209.64. Epub 2003 Apr 3.
- Background: PubMed 22278144Van Bortel LM, Laurent S, Boutouyrie P, Chowienczyk P, Cruickshank JK, De Backer T, Filipovsky J, Huybrechts S, Mattace-Raso FU, Protogerou AD, Schillaci G, Segers P, Vermeersch S, Weber T; Artery Society; European Society of Hypertension Working Group on Vascular Structure and Function; European Network for Noninvasive Investigation of Large Arteries. Expert consensus document on the measurement of aortic stiffness in daily practice using carotid-femoral pulse wave velocity. J Hypertens. 2012 Mar;30(3):445-8. doi: 10.1097/HJH.0b013e32834fa8b0.
- Background: PubMed 29761092Xu SK, Hong XF, Cheng YB, Liu CY, Li Y, Yin B, Wang JG. Validation of a Piezoelectric Sensor Array-Based Device for Measurement of Carotid-Femoral Pulse Wave Velocity: The Philips Prototype. Pulse (Basel). 2018 Mar;5(1-4):161-168. doi: 10.1159/000486317. Epub 2018 Feb 8.
- Background: PubMed 2598428Kelly R, Hayward C, Avolio A, O'Rourke M. Noninvasive determination of age-related changes in the human arterial pulse. Circulation. 1989 Dec;80(6):1652-9. doi: 10.1161/01.cir.80.6.1652.
- Background: PubMed 25736440Chirinos JA, Segers P, Duprez DA, Brumback L, Bluemke DA, Zamani P, Kronmal R, Vaidya D, Ouyang P, Townsend RR, Jacobs DR Jr. Late systolic central hypertension as a predictor of incident heart failure: the Multi-ethnic Study of Atherosclerosis. J Am Heart Assoc. 2015 Mar 3;4(3):e001335. doi: 10.1161/JAHA.114.001335.
- Background: PubMed 21976274Ding FH, Fan WX, Zhang RY, Zhang Q, Li Y, Wang JG. Validation of the noninvasive assessment of central blood pressure by the SphygmoCor and Omron devices against the invasive catheter measurement. Am J Hypertens. 2011 Dec;24(12):1306-11. doi: 10.1038/ajh.2011.145. Epub 2011 Oct 6.
- Background: PubMed 24892879Pereira T, Maldonado J, Coutinho R, Cardoso E, Laranjeiro M, Andrade I, Conde J. Invasive validation of the Complior Analyse in the assessment of central artery pressure curves: a methodological study. Blood Press Monit. 2014 Oct;19(5):280-7. doi: 10.1097/MBP.0000000000000058.
- Background: PubMed 32033495Wang TW, Lin SF. Wearable Piezoelectric-Based System for Continuous Beat-to-Beat Blood Pressure Measurement. Sensors (Basel). 2020 Feb 5;20(3):851. doi: 10.3390/s20030851.
- Background: PubMed 35300400Park J, Seok HS, Kim SS, Shin H. Photoplethysmogram Analysis and Applications: An Integrative Review. Front Physiol. 2022 Mar 1;12:808451. doi: 10.3389/fphys.2021.808451. eCollection 2021.
- BackgroundI.B. Wilkinson, C.M. McEniery, G. Schillaci, P. Boutouyrie, P. Segers, A. Donald, et al. ARTERY Society guidelines for validation of non-invasive haemodynamic measurement devices: part 1, arterial pulse wave velocity Artery Res, 4 (2) (2010), p. 34
- 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. This study is not recruiting at the moment.
Jess Goodman, M.D. principal investigator
VitalSines International Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Pulse Wave Velocity, run by VitalSines International Inc..
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 12 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: status not confirmed, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jess Goodman, M.D. (416-670-9306, jess@goiheart.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic Pulse Wave Velocity (time frame: 6 measurements per subject, each lasting 60 seconds). 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 NCT05400421, which also lists 11 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 6 Jun 2022.