Clinical trial NCT06984211: Vibrometer Based Pulse Wave Analysis for Arterial Stiffness and Ischemic Heart Disease Risk Assessment
Official title: Cardio Alpha - Vibrometer Based Pulse Wave Analysis for Arterial Stiffness and Ischemic Heart Disease Risk Assessment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Ischemic Heart Disease
Valvular Heart Disease
Heart Failure
Diabetes
Lead sponsor: HJN Sverige AB/Neko Health
Sponsor class: INDUSTRY
First posted: 2025-05-22
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study participants mainly consist of a prospective primary care population. 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.

An extended investigation 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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
measure: 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.
measure: 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)..
measure: 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).
measure: 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).
measure: 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.
measure: 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.
Secondary outcomes:
measure: Assess correlation between vibrometer-based PWV and other PWV reference methods
timeFrame: Typically same day as enrolment, or within 3-6 months of enrolment (extended visit). If 1-year follow-up, then within 1 year and 3-6 months from enrolment.
measure: Assess correlation between vibrometer-based LVET and ultrasound-based LVET
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).
measure: Assess correlation between vibrometer-based LVET and aortic valve Vmax by ultrasound continuous doppler signal
timeFrame: Same day as enrolment, or within 3-6 months of enrolment (extended visit). If 1-year follow-up visit, then 1 year and 3-6 months from enrolment (follow-up extended visit).
measure: Association between prevalence of hypertension and cardiac output and peripheral resistance
timeFrame: Same day as enrolment, or typically within 3-6 months of enrolment, (extended visit). If attending a 1-year follow-up, then around 1 year and 3-6 months from enrolment (follow-up extended visit).
measure: Assess associations between vibrometer measurements and measures of increased cardiovascular risk by pulse pressure
timeFrame: Typically at initial visit, same day as enrolment, or at extended visit. If attending a 1-year follow-up, then around 1 year from enrolment.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Atrium Health Care Centre
city: Stockholm
country: Sweden
facility: Neko Health Centre, Regeringsgatan
city: Stockholm
country: Sweden
facility: Neko Health Centre, Sibyllegatan
Study officials:
affiliation: Neko Health AB
name: Henrik Hellqvist, MD
role: PRINCIPAL_INVESTIGATOR
References: