HypertensionInSide-CCNCT05711693
Measurement of Heart-carotid Pulse Wave Velocity (hcPWV) by Laser Doppler Vibrometry (LDV)
A study testing Laser doppler vibrometry (LDV), heart(cordium) carotid pulse wave velocity (ccPWV), Blood pressure and heart rate measurement and carotid to femoral PWW measurement in people with Hypertension and Aortic Aneurysm, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Aortic stiffness is an important imaging biomarker of vascular aging. The ascending aorta is the most elastic segment, and it is excluded by reference non-invasive method carotid to femoral pulse wave velocity (PWV). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertension, Aortic Aneurysm, Bicuspid Aortic Valve
- What is being tested?
- Laser doppler vibrometry (LDV), heart(cordium) carotid pulse wave velocity (ccPWV), Blood pressure and heart rate measurement and carotid to femoral PWW measurement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2023to 19 Jun 2024
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 90 years of age in both sexes, who visit the hospital for MRI thoracic MRI as part of routine care.
- Enrolled in a social security plan or beneficiary of such a plan.
- Free, informed, written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any examination required by the research).
- and before any examination required by the research and even before the thoracic MRI planned in the care setting).
Who cannot join
- Individuals under court protection, guardianship or under curator.
- MRI examination done in an emergency context
- Patients with skin lesions (severe eczema, wounds, etc.) in the thorax or neck that do not allow the application of not allowing the application of the skin protection film on the area of interest;
- Allergies to the adhesive film.
- Patients who have a beard, which would make it difficult to apply an adhesive cast.
- Subjects who are not affiliated with social security or an equivalent plan.
Show all 13Show fewer
- Refusal or linguistic or psychic incapacity to read the information and not object to the research.
- Patients with a serious pathology threatening the vital prognosis in the short and medium term (cancer metastatic cancer, end-stage renal failure, end-stage liver failure, end-stage heart failure) heart failure).
- Patients with a history of acute severe (II, IV) heart failure.
- Patients with progressive cardiovascular pathologies (unstable coronary artery disease, severe valvular disease,stroke, aortic dissection).
- Rhythm disorders: atrial fibrillation, high degree auriculoventricular block.
- Pregnant or breastfeeding women
- Person subject to an exclusion period for another research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Silicon Photonics for Cardiovascular Disease Monitoring InSiDe-CC Clinical Validation of the Diagnostic Device (LDV) for the Measurement of Heart-carotid Pulse Wave Velocity (PWV) by Magnetic Resonance Imaging (MRI)
Aortic stiffness is an important imaging biomarker of vascular aging. The ascending aorta is the most elastic segment, and it is excluded by reference non-invasive method carotid to femoral pulse wave velocity (PWV). We propose to use laser-doppler vibrometry (LDV) to record superficial vibrations generated by cardiac activity and arterial pulses for measuring heart carotid PWV, a surrogate for ascending aorta.
The trial aims to demonstrate the equivalence between heart-carotid PWV made by laser-doppler vibrometry (LDV) with the reference MRI measurement (4D-FLOW MRI).
As secondary objectives, A) we aim to assess the reproducibility of LDV, compared with MRI, B) show that aortic stiffness measured by LDV fulfils international recommendations, C) to study the association between PWV and age or other cardiovascular risk factors, D) assess the acceptability of the measurement. For this, we include 100 consecutive patients, 50 women, 50 men, scheduled for clinically indicated thoracic aorta MRI.
Read the detailed description
Cardiovascular (CV) diseases and their risk factors are the leading causes of morbidity and mortality in the world. They are responsible for more than 17.3 million deaths per year worldwide, accounting for 30% of all causes of death.
The measurement of arterial stiffness is useful to estimate the global CV risk with more precision than the simple point assessment of the classical cardiovascular risk factors.
Carotid-femoral pulse wave velocity (cfPWV) by tonometry is the reference method. However, it excludes by principle the ascending aorta, which is the most distensible and physiologically the most important segment. The InSiDe project aims to measure heart - carotid pulse wave velocity (hcPWV) from the measurement of skin vibrations on the chest and neck by laser doppler vibrometry (LDV), enclosing principally the ascending aorta. This will allow the measurement and validation of a new biomarker that quantifies the stiffness of the ascending aorta. We have demonstrated a very good agreement of the LDV-based cfPWV with the reference technique by tonometry. Our hypothesis, based on physiological reasons, is that heart-carotid PWV will surpass carotid-femoral PWV as a biomarker of large artery stiffness.
The trial aims to demonstrate the equivalence between heart-carotid PWV measured by laser-doppler vibrometry (LDV) with the reference MRI measurement (4D-FLOW MRI). MRI, the gold standard comparator is technically demanding and uncomfortable for the patient, much more expensive and not applicable at the general population level. It is therefore likely that measurement by laser-doppler vibrometry, without contact, more comfortable, acceptable and fast, could replace MRI for mass applications.
For this, we include 100 consecutive patients, 50 women, 50 men, scheduled for clinically indicated thoracic aorta MRI.
ENDPOINTS
Primary endpoint:
- Heart-carotid PWV measured by LDV. To evaluate the agreement between heart-carotid PWV measured by LDV and the same measurement made by MRI (plus 4D-FLOW MRI) of the thorax.
Secondary endpoints:
- Reproducibility of the LDV hcPWV
- Measurement of LDV cfPWV compared with tonometry
- Association between PWV (hc, cf, LDV, MRI), and age, other risk factors
- Assessment of patient acceptability of the measurement
Statistical analysis The statistical technique used will be the Bland - Altman plot and the corresponding bias assessment (mean Bland-Altman bias and limits of agreement, defined as the mean bias ±1.96 - standard deviation, are provided); the coefficient of variation (CV) will also be used.
Description of the device being investigated:
The LDV device, developed by the European consortium CARDIS (Medtronic,SIOS, iMEC, Tyndall Institute) uses two arrays with 6 laser beams. It is a non-invasive exploration, by category 1 laser without any risk for the patient and allows to measure the local arterial stiffness (to evaluate the heart-carotid PWV) and segmental without contact with the skin by using the LDV technique. In practice, this device allows the evaluation of the hcPWV from the measurement of skin vibrations on the chest and neck.
Description of the device used as a comparator:
The reference technique is MRI, used in combination with 4D-FLOW MRI, an innovative technique that allows full 3-dimensional anatomical coverage as well as velocity coding in all 3 directions, opening new and unique possibilities for visualizing and quantifying complex cardiovascular blood flow
- Being tested
- Laser doppler vibrometry (LDV), heart(cordium) carotid pulse wave velocity (ccPWV), Blood pressure and heart rate measurement, carotid to femoral PWW measurement, Questionnaire completion
- Keywords
- stiffness, hypertension, ascending aorta
- Medical subject headings
- Hypertension, Aortic Aneurysm, Bicuspid Aortic Valve Disease, Marfan Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser doppler vibrometry (LDV), heart(cordium) carotid pulse wave velocity (ccPWV)Device
Patients scheduled for thoracic aorta MRI will have LDV measurement of ccPWV. Both techniques will be compared
Blood pressure and heart rate measurementProcedure or surgery
To all patients:
- blood pressure and heart rate will be measured
carotid to femoral PWW measurementDevice
To all patients:
- carotid to femoral PWW will be measured by LDV and tonometry for comparison
Questionnaire completionProcedure or surgery
All patients will complete a questionnaire of acceptability
| Study group | Role | What they receive |
|---|---|---|
| Technique comparison | Experimental | All patients will undergo successively LDV heart to carotid PWV and ascending aorta PWV by MRI, for comparison Receives: Device: Laser doppler vibrometry (LDV), heart(cordium) carotid pulse wave velocity (ccPWV); Procedure: Blood pressure and heart rate measurement; Device: carotid to femoral PWW measurement; Procedure: Questionnaire completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart-carotid pulse wave velocity (hcPWV) measured by LDV compared to MRI
Values of PWV obtained by LDV and by MRI will be compared.
Measured: 1 hour
Secondary outcomes (4)
Reproducibility of LDV heart-carotid pulse wave velocity (hcPWV)
Measures will be duplicated and the average calculated, in case of discrepancy > 0.5 m/s, a third measurement is made and the median determined. Two series of measurements will be taken at 5minutes of interval.
Measured: 1 hour
Validity of carotid to femoral pulse wave velocity (cfPWV) measured by LDV
Values of cfPWV obtained by LDV will be also compared with values obtained by tonometry.
Measured: 1 hour
Association of heart-carotid pulse wave velocity (hcPWV) measured by LDV with classical cardiovascular (CV) risk factors and disease
The correlation coefficient and linear regression will be calculated.
Measured: 1 hour
Acceptability of heart-carotid pulse wave velocity (hcPWV) measured by LDV compared with MRI
A questionnaire of acceptability will be completed by the patient after the measurements.
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 posted3 Feb 2023
- Study start13 Mar 2023
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Comparison of methods
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre Boutouyrie, Principal investigator, Hôpital Européen Georges-Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711693
- Sponsor's protocol ID
- C21-28
- Other IDs
- 2021-A02896-35
- Acronym
- InSide-CC
- Status last verified
- Nov 2024
- First submitted
- 6 Jan 2023
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beeckman S, Badhwar S, Li Y, Aasmul S, Madhu N, Khettab H, Mousseaux E, Gencer U, Boutouyrie P, Bruno RM, Segers P. Heart-carotid pulse-wave velocity via laser-Doppler vibrometry as a biomarker for arterial stiffening: a feasibility study. Physiol Meas. 2025 Apr 22;46(4). doi: 10.1088/1361-6579/adcb85.
PubMed 40209757
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Silicon Photonics for Cardiovascular Disease Monitoring InSiDe-CC Clinical Validation of the Diagnostic Device (LDV) for the Measurement of Heart-carotid Pulse Wave Velocity (PWV) by Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT05711693
- Acronym / sponsor ID
- InSide-CC / C21-28
- Keywords
- stiffness, hypertension, ascending aorta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 3 Feb 2023 (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.
Aortic stiffness is an important imaging biomarker of vascular aging. The ascending aorta is the most elastic segment, and it is excluded by reference non-invasive method carotid to femoral pulse wave velocity (PWV). We propose to use laser-doppler vibrometry (LDV) to record superficial vibrations generated by cardiac activity and arterial pulses for measuring heart carotid PWV, a surrogate for ascending aorta.
The trial aims to demonstrate the equivalence between heart-carotid PWV made by laser-doppler vibrometry (LDV) with the reference MRI measurement (4D-FLOW MRI).
As secondary objectives, A) we aim to assess the reproducibility of LDV, compared with MRI, B) show that aortic stiffness measured by LDV fulfils international recommendations, C) to study the association between PWV and age or other cardiovascular risk factors, D) assess the acceptability of the measurement. For this, we include 100 consecutive patients, 50 women, 50 men, scheduled for clinically indicated thoracic aorta MRI.
Detailed description
Cardiovascular (CV) diseases and their risk factors are the leading causes of morbidity and mortality in the world. They are responsible for more than 17.3 million deaths per year worldwide, accounting for 30% of all causes of death.
The measurement of arterial stiffness is useful to estimate the global CV risk with more precision than the simple point assessment of the classical cardiovascular risk factors.
Carotid-femoral pulse wave velocity (cfPWV) by tonometry is the reference method. However, it excludes by principle the ascending aorta, which is the most distensible and physiologically the most important segment. The InSiDe project aims to measure heart - carotid pulse wave velocity (hcPWV) from the measurement of skin vibrations on the chest and neck by laser doppler vibrometry (LDV), enclosing principally the ascending aorta. This will allow the measurement and validation of a new biomarker that quantifies the stiffness of the ascending aorta. We have demonstrated a very good agreement of the LDV-based cfPWV with the reference technique by tonometry. Our hypothesis, based on physiological reasons, is that heart-carotid PWV will surpass carotid-femoral PWV as a biomarker of large artery stiffness.
The trial aims to demonstrate the equivalence between heart-carotid PWV measured by laser-doppler vibrometry (LDV) with the reference MRI measurement (4D-FLOW MRI). MRI, the gold standard comparator is technically demanding and uncomfortable for the patient, much more expensive and not applicable at the general population level. It is therefore likely that measurement by laser-doppler vibrometry, without contact, more comfortable, acceptable and fast, could replace MRI for mass applications.
For this, we include 100 consecutive patients, 50 women, 50 men, scheduled for clinically indicated thoracic aorta MRI.
ENDPOINTS
Primary endpoint:
- Heart-carotid PWV measured by LDV. To evaluate the agreement between heart-carotid PWV measured by LDV and the same measurement made by MRI (plus 4D-FLOW MRI) of the thorax.
Secondary endpoints:
- Reproducibility of the LDV hcPWV
- Measurement of LDV cfPWV compared with tonometry
- Association between PWV (hc, cf, LDV, MRI), and age, other risk factors
- Assessment of patient acceptability of the measurement
Statistical analysis The statistical technique used will be the Bland - Altman plot and the corresponding bias assessment (mean Bland-Altman bias and limits of agreement, defined as the mean bias ±1.96 - standard deviation, are provided); the coefficient of variation (CV) will also be used.
Description of the device being investigated:
The LDV device, developed by the European consortium CARDIS (Medtronic,SIOS, iMEC, Tyndall Institute) uses two arrays with 6 laser beams. It is a non-invasive exploration, by category 1 laser without any risk for the patient and allows to measure the local arterial stiffness (to evaluate the heart-carotid PWV) and segmental without contact with the skin by using the LDV technique. In practice, this device allows the evaluation of the hcPWV from the measurement of skin vibrations on the chest and neck.
Description of the device used as a comparator:
The reference technique is MRI, used in combination with 4D-FLOW MRI, an innovative technique that allows full 3-dimensional anatomical coverage as well as velocity coding in all 3 directions, opening new and unique possibilities for visualizing and quantifying complex cardiovascular blood flow
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Comparison of methods
| Arm | Type | Receives |
|---|---|---|
| Technique comparison | Experimental | Device: Laser doppler vibrometry (LDV), heart(cordium) carotid pulse wave velocity (ccPWV), Procedure: Blood pressure and heart rate measurement, Device: carotid to femoral PWW measurement, Procedure: Questionnaire completionAll patients will undergo successively LDV heart to carotid PWV and ascending aorta PWV by MRI, for comparison |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients between 18 and 90 years of age in both sexes, who visit the hospital for MRI thoracic MRI as part of routine care.
- Enrolled in a social security plan or beneficiary of such a plan.
- Free, informed, written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any examination required by the research).
- and before any examination required by the research and even before the thoracic MRI planned in the care setting).
Key exclusion criteria (13 listed)
- Individuals under court protection, guardianship or under curator.
- MRI examination done in an emergency context
- Patients with skin lesions (severe eczema, wounds, etc.) in the thorax or neck that do not allow the application of not allowing the application of the skin protection film on the area of interest;
- Allergies to the adhesive film.
- Patients who have a beard, which would make it difficult to apply an adhesive cast.
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 |
|---|---|---|
| Laser doppler vibrometry (LDV), heart(cordium) carotid pulse wave velocity (ccPWV)Patients scheduled for thoracic aorta MRI will have LDV measurement of ccPWV. Both techniques will be compared | Device | Technique comparison |
| Blood pressure and heart rate measurementTo all patients: - blood pressure and heart rate will be measured | Procedure or surgery | Technique comparison |
| carotid to femoral PWW measurementTo all patients: - carotid to femoral PWW will be measured by LDV and tonometry for comparison | Device | Technique comparison |
| Questionnaire completionAll patients will complete a questionnaire of acceptability | Procedure or surgery | Technique comparison |
Primary outcome
Heart-carotid pulse wave velocity (hcPWV) measured by LDV compared to MRI
Time frame: 1 hour
Values of PWV obtained by LDV and by MRI will be compared.
4 secondary outcomes
Reproducibility of LDV heart-carotid pulse wave velocity (hcPWV)
Time frame: 1 hour
Validity of carotid to femoral pulse wave velocity (cfPWV) measured by LDV
Time frame: 1 hour
Association of heart-carotid pulse wave velocity (hcPWV) measured by LDV with classical cardiovascular (CV) risk factors and disease
Time frame: 1 hour
Acceptability of heart-carotid pulse wave velocity (hcPWV) measured by LDV compared with MRI
Time frame: 1 hour
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 29 Aug 2025.
- Results publication: PubMed 40209757Beeckman S, Badhwar S, Li Y, Aasmul S, Madhu N, Khettab H, Mousseaux E, Gencer U, Boutouyrie P, Bruno RM, Segers P. Heart-carotid pulse-wave velocity via laser-Doppler vibrometry as a biomarker for arterial stiffening: a feasibility study. Physiol Meas. 2025 Apr 22;46(4). doi: 10.1088/1361-6579/adcb85.
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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.
Pierre Boutouyrie principal investigator
Hôpital Européen Georges-Pompidou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser doppler vibrometry (LDV), heart(cordium) carotid pulse wave velocity (ccPWV), Blood pressure and heart rate measurement and carotid to femoral PWW measurement in people with Hypertension and Aortic Aneurysm, run by Institut National de la Santé Et de la Recherche Médicale, France 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 4 inclusion and 13 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 29 Aug 2025. 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?
Heart-carotid pulse wave velocity (hcPWV) measured by LDV compared to MRI (time frame: 1 hour). 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 NCT05711693, which also lists 1 linked publication.
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 29 Aug 2025.