This clinical investigation will evaluate a novel contactless technology for assessing arterial stiffness and explore its potential in assessment of risk for and development of cardiovascular disease. The main aims of the study are: 1. To assess device and method performance for assessment of arterial stiffness and cardiovascular risk, on a prospective primary care cohort. 2. To see if precision may be added in CVD risk assessment through a multi-modal approach, combining data on macro- and micro-circulatory function.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Correlation between vibrometer-based PWV and ultrasound-based PWV
Timeframe: Typically same day or within 3-6 months of enrolment, at extended visit. If attending a 1-year follow-up, then around 1 year and 3-6 months from enrolment (follow-up extended visit).
Assess associations between vibrometer measurements and clinical measures of increased cardiovascular risk
Timeframe: Typically within 3 months of initial visit and enrolment, at extended visit. If attending a 1-year follow-up, then around 1 year and 3 months from enrolment.
Assess prediction performance of increased cardiovascular risk when combining vibrometer measurements, brachial BP, ABI and ECG in prediction models
Timeframe: Typically within 3-6 months of enrolment (extended visit). If attending a 1-year follow-up, then around 1 year and 3 months from enrolment (follow-up extended visit)..
Assess performance of a multimodal risk score using data from the current study and the in parallel performed investigation "Spectrum 1" (CIV ID: CIV-22-07-039907).
Timeframe: Typically within 3-6 months after enrolment (extended visit). May include 1-year follow-up, in which case 1 year and 3-6 months (follow-up extended visit).
Assess associations between vibrometer measurements and presence of aortic valve pathology
Timeframe: Typically within 3-6 months of enrolment, at extended visit. If attending a 1-year follow-up, then around 1 year and 3-6 months from enrolment (follow-up extended visit).
Assess associations between vibrometer measurements and ankle-brachial index
Timeframe: Typically at initial visit, same day as enrolment. If attending a 1-year follow-up, then around 1 year from enrolment.
Assess associations between vibrometer measurements and measure of increased cardiovascular risk by risk score
Timeframe: Typically at initial visit, same day as enrolment. If attending a 1-year follow-up, then around 1 year from enrolment.