Vibrometer Based Pulse Wave Analysis for Arterial Stiffness and Ischemic Heart Disease Risk Assessment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHJN Sverige AB/Neko Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
8,000 Participants
are grouped into 1 trial groupGroup A: patient_cohort
Trial outcomes
Primary outcomes
1
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.
Time frame
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).2
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.
Time frame
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.3
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).
Time frame
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)..4
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.
Time frame
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).Secondary outcomes
1
Assess correlation between vibrometer-based PWV and other PWV reference methods
Vibrometer-based PWV in relation to other reference methods for assessment of PWV, such as a single brachial-cuff based method (Arteriograph, Tensiomed), and peripheral piezo sensors (located on hands and feet). PWV in m/s, a measure of arterial stiffness.
Time frame
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.2
Assess correlation between vibrometer-based LVET and ultrasound-based LVET
Vibrometer-based LVET as assessed by detection of systolic onset and end, in relation to ultrasound-based LVET as assessed by LVET measured directly at the left ventricular outflow tract.
Time frame
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).3
Assess correlation between vibrometer-based LVET and aortic valve Vmax by ultrasound continuous doppler signal
Vibrometer-based LVET as assessed by detection of systolic onset and end in relation to peak aortic jet velocity (Vmax) assessed by continuous doppler signal. Vmax is a measure of the speed at which blood travels across the aortic valve.
Time frame
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).4
Association between prevalence of hypertension and cardiac output and peripheral resistance
Association between blood pressure and ultrasound-derived markers for cardiac output and peripheral resistance.
Time frame
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov