HypertensionNCT06984211
Vibrometer Based Pulse Wave Analysis for Arterial Stiffness and Ischemic Heart Disease Risk Assessment
An observational study of Hypertension and Ischemic Heart Disease, run by HJN Sverige AB/Neko Health at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Ischemic Heart Disease, Valvular Heart Disease
- How many people
- 8,000 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Feb 2023to 1 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Atrium Health Care Centre
Stockholm
Andreea Valdman, MD, +4673 939 27 11, andreea@nekohealth.com
Henrik Hellqvist, MD
- Recruiting
Neko Health Centre, Regeringsgatan
Stockholm
Andreea Valdman, MD, +4673 939 27 11, andreea@nekohealth.com
Yuan Tan, yuan.tan@nekohealth.com
- Recruiting
Neko Health Centre, Sibyllegatan
Stockholm
Andreea Valdman, MD, +4673 939 27 11, andreea@nekohealth.com
Henrik Hellqvist, MD
About this study
Official title: Cardio Alpha - Vibrometer Based Pulse Wave Analysis for Arterial Stiffness and Ischemic Heart Disease Risk Assessment
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:
- To assess device and method performance for assessment of arterial stiffness and cardiovascular risk, on a prospective primary care cohort.
- To see if precision may be added in CVD risk assessment through a multi-modal approach, combining data on macro- and micro-circulatory function.
Read the 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.
- Medical subject headings
- Hypertension, Myocardial Ischemia, Heart Valve Diseases, Heart Failure, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Association between blood pressure and ultrasound-derived markers for cardiac output and peripheral resistance.
Measured: 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
Vibrometer-derived PWV measurements in relation to increased risk for CVD as assessed by pulse pressure.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Feb 2023
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HJN Sverige AB/Neko Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henrik Hellqvist, MD, Principal investigator, Neko Health AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984211
- Sponsor's protocol ID
- CRD-P3-LMV_CIP-220623
- Status last verified
- May 2025
- First submitted
- 1 Aug 2023
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio Alpha - Vibrometer Based Pulse Wave Analysis for Arterial Stiffness and Ischemic Heart Disease Risk Assessment
- ClinicalTrials.gov ID
- NCT06984211
- Acronym / sponsor ID
- CRD-P3-LMV_CIP-220623
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- HJN Sverige AB/Neko HealthIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess device and method performance for assessment of arterial stiffness and cardiovascular risk, on a prospective primary care cohort.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between vibrometer-based PWV and ultrasound-based PWV
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).
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.
Assess associations between vibrometer measurements and clinical measures of increased cardiovascular risk
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.
Vibrometer-derived PWV association with risk or presence of established atherosclerotic cardiovascular disease (ASCVD) based on ultrasound or clinical assessment.
Assess prediction performance of increased cardiovascular risk when combining vibrometer measurements, brachial BP, ABI and ECG in prediction models
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)..
Combining vibrometer measurements, brachial BP, ABI, TBI and ECG in prediction models, may provide an improved prediction of increased cardiovascular risk (as defined above).
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).
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).
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.
Assess associations between vibrometer measurements and presence of aortic valve pathology
Time frame: 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).
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.
Assess associations between vibrometer measurements and ankle-brachial index
Time frame: Typically at initial visit, same day as enrolment. If attending a 1-year follow-up, then around 1 year from enrolment.
Vibrometer-derived PWV measurements in relation to increased risk for CVD as assessed by ankle-brachial index (ABI).
Assess associations between vibrometer measurements and measure of increased cardiovascular risk by risk score
Time frame: Typically at initial visit, same day as enrolment. If attending a 1-year follow-up, then around 1 year from enrolment.
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.
5 secondary outcomes
Assess correlation between vibrometer-based PWV and other PWV reference methods
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.
Assess correlation between vibrometer-based LVET and ultrasound-based LVET
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).
Assess correlation between vibrometer-based LVET and aortic valve Vmax by ultrasound continuous doppler signal
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).
Association between prevalence of hypertension and 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).
Assess associations between vibrometer measurements and measures of increased cardiovascular risk by pulse pressure
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Henrik Hellqvist, MD principal investigator
Neko Health AB
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Ischemic Heart Disease, run by HJN Sverige AB/Neko Health at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mattias Windå, MSc (+46703169040, mattias@nekohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between vibrometer-based PWV and ultrasound-based PWV (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).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.