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

HJN Sverige AB/Neko Health

Status: Enrolling

Conditions: Ischemic Heart Disease; Hypertension; Diabetes; Valvular Heart Disease; Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT06984211

CRD-P3-LMV_CIP-220623

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult patients that are part of the regular healthcare patient flow at the investigational sites, or as separately invited to participate in this investigation.
• Patients with signed informed consent

Exclusion criteria

• Cognitive impairment
• Patients unable to understand the oral and written study information in Swedish or English
• Other severe disorder or terminal disease, e.g. infection/sepsis, severe COPD or metastatic cancers.
• Patients unable to provide an informed consent

Trial design

8,000 participants in 1 patient group

patient_cohort

Description:

Adult patients mainly from a primary care cohort. All patients visiting the clinical sites, seeking care, or as separately invited, are offered to participate in this investigation. This includes sub-groups of patients with hypertension, valvular disease or risk for IHD. All participants undergo at least one examination with the investigational device (Cardio P3) at initial visit.