Vibrometer Based Pulse Wave Analysis for Arterial Stiffness and Ischemic Heart Disease Risk Assessment

Conditions studied

Hypertension, Ischemic Heart Disease, Valvular Heart Disease, Heart Failure, Diabetes

About this study

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.

Primary outcomes

• Correlation between vibrometer-based PWV and ultrasound-based PWV (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 (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 (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). (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 (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 (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 (Typically at initial visit, same day as enrolment. If attending a 1-year follow-up, then around 1 year from enrolment.)