Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05711693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-03
First Post:
2023-01-06
Brief Title:
Measurement of Heart-carotid Pulse Wave Velocity hcPWV by Laser Doppler Vibrometry LDV
Sponsor:
Institut National de la Santé Et de la Recherche Médicale France
Organization:
Institut National de la Santé Et de la Recherche Médicale France
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
InSide-CC
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
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 173 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 196 - 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 MedtronicSIOS 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
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 196 - 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 MedtronicSIOS 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-A02896-35 | REGISTRY | IDRCB | None |