NCT06984211

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 8,000 (estimated)
• Sponsor: HJN Sverige AB/Neko Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Arterial stiffness, commonly assessed as pulse wave velocity (PWV), is a marker of aging of the cardio-vascular system strongly associated with hypertension and increased risk for and development of cardiovascular disease. This clinical investigation aims at evaluating the clinical safety, performance and potential value of a novel laser-radar-based vibrometer technology, for the assessment of arterial stiffness and to explore correlations of various measurements made with the technology with risk and development of cardiovascular disease, specifically ischemic heart disease, hypertension and aortic valve pathology. The study participants mainly consist of a prospective primary care population, that undergo an investigation (including vibrometer and microwave radar assessment, blood pressure, ECG and ankle-brachial index) at a primary care visit. An extended investigation (including vibrometer assessment, cardiovascular ultrasound and other reference methods for pulse wave velocity and cardiovascular risk assessment) will be offered to participants judged to have an increased risk of cardiovascular disease in the primary care population, or for separately invited subjects with increased cardiovascular risk, known valvular disease, or as healthy controls. Repeated yearly measurements plan to be performed in interested subjects. A subset of the participants will undergo a contactless multi-modal investigation which includes combining data from the current study with contactless spatial frequency domain data from the investigation "Spectrum 1" (CIV ID: CIV-22-07-039907). The hypothesis is that CVD risk assessment may be improved through a multi-modal approach, combining data on both macro- and micro-circulatory function. A subset of the data will be used to evaluate the association between the prevalence of hypertension and total peripheral resistance, as well as cardiac output. The study is of exploratory character with many analyses; however, the main outcomes are outlined below.

Conditions

• Hypertension
• Ischemic Heart Disease
• Valvular Heart Disease
• Heart Failure
• Diabetes

Timeline

• Start date: 2023-02-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2025-05-22
• Last updated: 2025-05-22

Locations

3 sites across 1 country: Sweden