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

NCT06984211 | Recruiting

• 1 other identifier: CRD-P3-LMV_CIP-220623
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 3

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. 1.To assess device and method performance for assessment of arterial stiffness and cardiovascular risk, on a prospective primary care cohort.
2. 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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• Correlation between vibrometer-based PWV and ultrasound-based PWV

  Vibrometer-based PWV in relation to ultrasound-based PWV, including both the carotid-femoral and aorto-femoral pathways. PWV in m/s, a measure of arterial stiffness.

  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

  Vibrometer-derived PWV association with risk or presence of established atherosclerotic cardiovascular disease (ASCVD) based on ultrasound or clinical assessment.

  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

  Combining vibrometer measurements, brachial BP, ABI, TBI and ECG in prediction models, may provide an improved prediction of increased cardiovascular risk (as defined above).

  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).

  Assess prediction of cardiovascular disease risk when adding parameters from the clinical study "Spectrum 1" to models based on parameters from the present study (vibrometer-based parameters, brachial BP, ABI, TBI, ECG). Outcome will be defined by presence of CVD risk or confirmed CVD based on ultrasound or clinical information, increased risk by risk scores, familial hypercholesterolemia, diabetes mellitus.

  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

  Vibrometer measurements, including left ventricular ejection time (LVET), in relation to aortic valve pathology, including aortic sclerosis, stenosis, or insufficiency, ranging from none to severe, and bicuspid aorta valve, assessed by ultrasound.

  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

  Vibrometer-derived PWV measurements in relation to increased risk for CVD as assessed by ankle-brachial index (ABI).

  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

  Vibrometer-derived PWV measurements in relation to increased risk for CVD as assessed by established risk score (SCORE2). SCORE 2 is a risk prediction model to estimate 10-year risk of fatal or non-fatal atherosclerotic cardiovascular disease. Variables used in the model are age, sex, smoking status, systolic blood pressure and non-HDL cholesterol levels.

  Typically at initial visit, same day as enrolment. If attending a 1-year follow-up, then around 1 year from enrolment.

Secondary Outcomes (5)

• Assess correlation between vibrometer-based PWV and other PWV reference methods

  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.

• Assess correlation between vibrometer-based LVET and ultrasound-based LVET

  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 correlation between vibrometer-based LVET and aortic valve Vmax by ultrasound continuous doppler signal

  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).

• Association between prevalence of hypertension and cardiac output and peripheral resistance

  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).

• Assess associations between vibrometer measurements and measures of increased cardiovascular risk by pulse pressure

  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.

Study Arms (1)

patient_cohort

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HJN Sverige AB/Neko Health: lead

Study Sites (3)

Atrium Health Care Centre

Stockholm, Sweden

RECRUITING

Neko Health Centre, Regeringsgatan

Stockholm, Sweden

RECRUITING

Neko Health Centre, Sibyllegatan

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Hypertension; Myocardial Ischemia; Heart Valve Diseases; Heart Failure; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Henrik Hellqvist, MD

  Neko Health AB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mattias Windå, MSc

CONTACT

+46703169040; mattias@nekohealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: May 22, 2025
• Study Start: February 1, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)