Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05711693 |
Other study ID # |
C21-28 |
Secondary ID |
2021-A02896-35 |
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 1, 2023 |
Est. completion date |
July 1, 2024 |
Study information
Verified date |
January 2023 |
Source |
Institut National de la Santé Et de la Recherche Médicale, France |
Contact |
Pierre Boutouyrie |
Phone |
0156093991 |
Email |
pierre.boutouyrie[@]aphp.fr |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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). 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.
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