To Evaluate the Validity of the Measure Method, we Will Compare Vasculight v1.0 PWV Measures With Those Obtained From E-tracking (Echocardiographic Method). Clinical Trial
— NISTAS1Official title:
Non-invasive Screening of the Status of the Vascular System: Feasibility Test
This project is part of the EU funded project NISTAS. NISTAS aims at the development of a
new medical device for non-contact, non-invasive screening of the health status of the
vascular system of adult subjects. The instrument, called VascuLight, is intended to be
deployed at out-patient points-of-care and hospitals, and it provides output parameters
related to the PWV as measured at local and/or at regional level.
NISTAS brings together four European SMEs in four different, but complementary, technology
areas (JULIGHT, ECLEXYS, EPI-LIGHT, OIP) and links them with five RTD Performers (UNIPV,
OSM, CORK UNIVERSITY, Saphyrion, Eudax srl ) to develop new knowledge and a new medical
device which will have significant commercial benefits for all of the SME partners.
VascuLight responds to an unmet need in the medical diagnosis practice: the request for a
fast and sustainable method for the screening of the health of the vascular system in large
series, capable of providing a reliable indicator of the cardiovascular risk of the screened
subjects.
The VascuLight idea is founded on a paradigm shift: bringing and adapting to the biomedical
field measurement techniques that are to date confined to the industrial environment. NISTAS
will develop new non-contact distance/displacement/vibration sensors based on a variant of
the well-known and reliable laser triangulation technique.
JUL and UNIPV have carried out proof-of-concept, in-vivo tests of the VascuLight approach to
demonstrate that the concept is realistic and attainable. Results have been obtained using
Laser Doppler Vibrometry (LDV), a displacement-measuring technique based on the principle of
light interference, and an area where both JUL and UNIPV have made important contributions.
In the tests it was possible to use TWO small LDV optical heads to simultaneously measure
the pulse wave in two points on the carotid spaced by 2.5 cm, allowing for the calculation
of the time-delay between the pulse waves, and thus providing a direct local measurement of
the PWV.
The aim of the study is to test the implemented contactless optical technique for the
measurement of the PWV and the arterial stiffness at the carotid artery level.
To evaluate the validity of the measure method, the investigators will compare Vasculight
v1.0 PWV measures with those obtained from e-tracking (echocardiographic method) . The main
idea is to compare the distribution of measures (comparable mean and standard deviation) in
the same mixed adult population, using the two different methods.
| Status | Not yet recruiting |
| Enrollment | 50 |
| Est. completion date | April 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Age 18-65 Exclusion Criteria: 1. Systolic BP >160 mmHg or diastolic BP >100 mmHg 2. Treated hypertension 3. Diagnosis of type 1 or type 2 diabetes mellitus 4. Treated hypercholesterolaemia 5. Past or current, symptomatic or proven, coronary artery disease 6. Clinical cerebrovascular disease 7. Carotid arterial stenosis 8. Severe peripheral vascular disease 9. Hypertrophic or dilated cardiomyopathy 10. Congestive heart failure 11. Heart valve disease 12. Previous cardiac surgery 13. Congenital heart disease 14. Other systemic diseases such as cancers, endocrine diseases and autoimmune diseases 15. Any regular drug treatment |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Pavia |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pulse Wave velocity | Bland Altmann test and ROC analysis will be used to compare the 2 methods | 1 month | No |