Vibrometer Based Pulse Wave Analysis for Arterial Stiffness and Ischemic Heart Disease Risk Assessment
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…
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.)
Eligibility information
Study locations
- Atrium Health Care Centre, Stockholm, Sweden
- Neko Health Centre, Regeringsgatan, Stockholm, Sweden
- Neko Health Centre, Sibyllegatan, Stockholm, Sweden
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.