Measurement of Heart-carotid Pulse Wave Velocity (hcPWV) by Laser Doppler Vibrometry (LDV)

NCT05711693 | Completed

• 2 other identifiers: C21-282021-A02896-35
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Hypertension; Aortic Aneurysm; Bicuspid Aortic Valve; Marfan Syndrome; Aortic Dilatation

Keywords

stiffness; hypertension; ascending aorta

Outcome Measures

Primary Outcomes (1)

• Heart-carotid pulse wave velocity (hcPWV) measured by LDV compared to MRI

  Values of PWV obtained by LDV and by MRI will be compared.

  1 hour

Secondary Outcomes (4)

• Reproducibility of LDV heart-carotid pulse wave velocity (hcPWV)

  1 hour

• Validity of carotid to femoral pulse wave velocity (cfPWV) measured by LDV

  1 hour

• Association of heart-carotid pulse wave velocity (hcPWV) measured by LDV with classical cardiovascular (CV) risk factors and disease

  1 hour

• Acceptability of heart-carotid pulse wave velocity (hcPWV) measured by LDV compared with MRI

  1 hour

Study Arms (1)

Technique comparison

EXPERIMENTAL

All patients will undergo successively LDV heart to carotid PWV and ascending aorta PWV by MRI, for comparison

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

Interventions

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

Technique comparison

Blood pressure and heart rate measurement PROCEDURE

To all patients: \- blood pressure and heart rate will be measured

Technique comparison

carotid to femoral PWW measurement DEVICE

To all patients: \- carotid to femoral PWW will be measured by LDV and tonometry for comparison

Technique comparison

Questionnaire completion PROCEDURE

All patients will complete a questionnaire of acceptability

Technique comparison

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• and before any examination required by the research and even before the thoracic MRI planned in the care setting).

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Related Publications (1)

• 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.

  PMID: 40209757 BACKGROUND

MeSH Terms

Conditions

Hypertension; Aortic Aneurysm; Bicuspid Aortic Valve Disease; Marfan Syndrome

Interventions

Blood Pressure; Heart Rate

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Aneurysm; Aortic Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Aortic Valve Disease; Heart Valve Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Abnormalities, Multiple; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Pierre Boutouyrie

  Hôpital Européen Georges-Pompidou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: MRI doctors will be blinded concerning LDV PWV values. Doctors performing LDV will not have access to MRI reports. Data will be consolidated and database frozen before reconciling MRI and LDV data
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Comparison of methods

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: February 3, 2023
• Study Start: March 13, 2023
• Primary Completion: June 19, 2024
• Study Completion: June 19, 2024
• Last Updated: August 29, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)