Non-invasive Screening of the Status of the Vascular System: Feasibility Test

NCT ID: NCT02392260

Last Updated: 2015-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-04-30

Brief Summary

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.

Conditions

To Evaluate the Validity of the Measure Method, we Will Compare Vasculight v1.0 PWV Measures With Those Obtained From E-tracking (Echocardiographic Method).

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Vasculight prototype zero level

Group Type: EXPERIMENTAL

Vasculight

Intervention Type: DEVICE

Comparative measre of Pulse Wave velocity with both Vasculight prototype and Echocardiographic machine.

Interventions

Vasculight

Comparative measre of Pulse Wave velocity with both Vasculight prototype and Echocardiographic machine.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pavia

OTHER

Sponsor Role: lead

Responsible Party

Valentina Favalli

Biomedical Engeneer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Valentina Favalli, BME

Role: CONTACT

v.favalli@smatteo.pv.it

0039 0382 501487

Other Identifiers

20140008054

Identifier Type: -

Identifier Source: org_study_id