NCT05711693Completed
Measurement of Heart-carotid Pulse Wave Velocity (hcPWV) by Laser Doppler Vibrometry (LDV)
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)
Source: ClinicalTrials.gov · Last updated 29 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 6 Jan 2023
- Start date
- 13 Mar 2023
- Primary completion date
- 19 Jun 2024
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Diseases
- High blood pressure
- NCT number
- NCT05711693
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 13 Mar 2023 to the primary completion date, 19 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergies to the adhesive film.
- 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.
Other
- 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;
- 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.
- Refusal or linguistic or psychic incapacity to read the information and not object to the research.
- Pregnant or breastfeeding women
- Person subject to an exclusion period for another research
Who the study is looking for
- 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).
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.