Coronary Arterial Disease (CAD)NCT07001007
SCAPIS 2 Cardio - Vibrometer Based Pulse Wave Analysis and CVD Risk Assessment
An observational study of Coronary Arterial Disease (CAD) and Arterial Stiffness, run by HJN Sverige AB/Neko Health at 1 site in Sweden.
Trial summary
This clinical investigation will evaluate a novel contactless technology for assessing arterial stiffness and pulse wave characteristics and explore its potential in assessment of coronary artery disease, aortic stenosis and heart failure, in a population-based sample aged 58-72 years. Read more about this study
- Who is it for?
- Ages 58 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Arterial Disease (CAD), Arterial Stiffness, Aortic Valve Disease
- What is being tested?
- Coronary Computer Tomography (CCTA), Laser Doppler Vibrometry and single-lead ECG and Echocardiography
- Type of treatment
- Medical device
- How many people
- 1,600 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jul 2024to Jun 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 58 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In SCAPIS (2014 -2018) 30.000 randomly selected adults between the ages of 50 - 64 were included. SCAPIS 2 is the re-assessment study of half of the original study cohort. In Stockholm (Danderyd Hospital site) that corresponds to 2500 adults (that are now between 6-10 years older than the first SCAPIS study). The present study described in this CIP is a prospective, observational substudy of SCAPIS 2, done in collaboration with Karolinska Institutet (KIDS) and Danderyd Hospital.
Who may be able to join
- Subjects already included in the main / general SCAPIS 2 study at Danderyd Hospital in Stockholm, and of which has also participated in the echocardiography examination
Who cannot join
- Patients unable to provide an informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Danderyds Hospital, KFC - Hjärt-kärllaboratoriet
Stockholm
Karin Malmqvist, +46 8 12357184, karin.malmqvist@regionstockholm.se
About this study
This clinical investigation will evaluate a novel contactless technology for assessing arterial stiffness and pulse wave characteristics and explore its potential in assessment of coronary artery disease, aortic stenosis and heart failure, in a population-based sample aged 58-72 years.
It will be the first in clinical setting, pilot stage, observational investigation to evaluate the clinical safety, performance and diagnostic accuracy of Cardio P4, a laser-doppler vibrometry (LDV) and microwave radar-based device.
Read the detailed description
Cardiovascular disease (CVD) is the leading cause of death globally, placing a large burden on the healthcare system.
In asymptomatic individuals, there exists several risk scores to predict cardiovascular events (like SCORE2, SCORE2-OP and Framinham Risk Score). In patients with suspected symptoms of coronary artery disease, the European Society of Cardiology advice to estimate the pre-test probability by the risk factor-weighted clinical likelihood (RF-CL).
Most of these scores include the key factors for CAD development including age, sex, LDL- (or non-HDL) cholesterol, diabetes, smoking history, blood pressure or hypertension. Coronary computed tomography angiography (CCTA) is one of the main recommended examinations at low-intermediary risk based on PTP. While the procedure is non-invasive and relatively safe in comparison to invasive alternatives, they still represent a risk to the patient by radiation exposure and incidental findings, and is associated with lack of availability.
One key issue is that once a patient has a CCTA performed showing coronary atherosclerosis, that entails optimized prevention, with solid evidence. However, patients without symptoms of CAD are less studied regarding the degree of CAD. The present SCAPIS trial is the largest such trial on CCTA in 30 000 patients age 50 to 64 years, 25 182 individuals without known coronary heart disease were included. In these asymptomatic persons, CCTA-detected atherosclerosis was found in 42.1% and a significant stenosis (≥50%) in 5.2%.
Arterial stiffness, commonly assessed as pulse wave velocity (PWV), is a marker of aging of the cardiovascular system, and is independently associated with coronary artery disease. Increased arterial stiffness is an early indicator of cardiovascular disease and may improve precision in risk stratification. Laser-Doppler and microwave radar are new promising methods for analysis of pulse waves in human blood vessels. The technology may be more suitable for screening through enabling lower operator dependence and faster assessment time in comparison to standard assessment methods, and may contribute to lower overall healthcare costs and improved precision in identification of CVD.
Analysis of the pulse waveform characteristics such as time intervals and acceleration may in addition to PWV be useful as predictors of risk. We have shown that specific features from the early phase of the waveform (amplitude ratio) are most predictive when analysing similar pressure waveforms captured from the peripheral arteries (by photoplethysmography).
Cardiac timings extracted from a pulse waveform such as left ventricular ejection time and pre-ejection period are independent predictors of diseases such as aortic valve stenosis and heart failure, and may provide an effective method for risk estimation. The most common methods today for diagnosis of cardiac disease (such as aortic stenosis, heart failure) include laboratory tests, assessment of symptoms and echocardiography. Echocardiography is non-invasive, but has high reliance on operator skill which may cause variability in image acquisition and interpretation.
Machine-learning of many waveform features simultaneously, or feature-less analysis using neural networks and language-model driven analysis, may further improve the prediction.
The main aim of the study is to evaluate the potential value of a novel laser-radar-based vibrometer technology that can measure among several features arterial stiffness, and its possible role to improve risk stratification of coronary artery disease.
Secondary aims include to evaluate cardiac timings using laser doppler vibrometry for a possible role to improve risk stratification of patients with aortic stenosis and systolic or diastolic dysfunction.
- Being tested
- Coronary Computer Tomography (CCTA), Laser Doppler Vibrometry and single-lead ECG, Echocardiography, Pulse Wave Velocity
- Medical subject headings
- Aortic Valve Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Computer Tomography (CCTA)Diagnostic test
Use of standard equipment for usual care
Laser Doppler Vibrometry and single-lead ECGOther
Physiological data acquisition equipment
EchocardiographyDevice
GE Vivid E95
Pulse Wave VelocityDevice
Arteriograph, Tensiomed, Hungary
| Study group | Role | What they receive |
|---|---|---|
| SCAPIS2_cohort | In SCAPIS (2014 -2018) 30.000 randomly selected adults between the ages of 50 - 64 were included. SCAPIS 2 is the re-assessment study of half of the original study cohort. In Stockholm (Danderyd Hospital site) that corresponds to 2500 adults (that are now between 6-10 years older than the first SCAPIS study). The present study described in this CIP is a prospective, observational substudy of SCAPIS 2, done in collaboration with Karolinska Institutet (KIDS) and Danderyd Hospital. Receives: Diagnostic Test: Coronary Computer Tomography (CCTA); Other: Laser Doppler Vibrometry and single-lead ECG; Device: Echocardiography; Device: Pulse Wave Velocity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under receiver operating curve (ROC) to predict CAD-RADS ≥2
Change in area under receiver operating curve (ROC) to predict CAD-RADS ≥2 when adding Vibrometer-based SSN femoral PWV to the standard risk factors.
Coronary artery disease reporting and data system (CAD-RADS) ≥2 refers to the classification of coronary artery disease with at least moderate stenosis as identified on coronary computer tomography angiography. The classification follows the CAD-RADS 2.0 definition. Stenosis is graded in severity from 0-5.
Measured: Typically within 2 months of enrolment
Secondary outcomes (20)
Area under receiver operating curve (ROC) to predict CAD-RADS ≥3
Change in area under receiver operating curve (ROC) to predict CAD-RADS ≥3 when adding Vibrometer-based SSN femoral PWV to the standard risk factors.
Measured: Typically within 2 months of enrolment
Area under receiver operating curve (ROC) to predict CAD-RADS ≥2
Change in area under receiver operating curve (ROC) to predict CAD-RADS ≥2 when adding Vibrometer-based amplitude-ratio from the early phase of the waveform to the standard risk factors.
Measured: Typically within 2 months of enrolment
Area under receiver operating curve (ROC) to predict CAD-RADS ≥2 stratified by sex
Prespecified subgroup analysis stratified by sex. Change in area under receiver operating curve (ROC) to predict CAD-RADS ≥2 when adding Vibrometer-based SSN femoral PWV to the standard risk factors.
Measured: Typically within 2 months of enrolment
Area under receiver operating curve (ROC) to predict CAD-RADS ≥2 stratified by body mass index strata
Prespecified subgroup analysis stratified by body mass index strata. Change in area under receiver operating curve (ROC) to predict CAD-RADS ≥2 when adding Vibrometer-based SSN femoral PWV to the standard risk factors.
Measured: Typically within 2 months of enrolment
Correlation between vibrometer-based PWA from the suprasternal notch and PWV by Arteriograph
Vibrometer-based PWA (e.g. LVET, PEP) derived from the SSN in relation to PWV acquired by Arteriograph (Tensiomed Inc).
Measured: Typically within 2 months of enrolment
Correlation between vibrometer-based PWA from the suprasternal notch and CAD-RADS score
Vibrometer-based PWA (e.g. LVET, PEP) derived from the SSN in relation to degree of coronary artery disease by CAD-RADS.
Measured: Typically within 2 months of enrolment
Correlation between pressure sensor (piezo) based PWV and CAD-RADS score
Peripheral pressure sensor (piezo) based PWA (such as shape and properties) from sensors on the hands and feet in relation to degree of coronary artery disease by CAD-RADS
Measured: Typically within 2 months of enrolment
Correlation between vibrometer-based PWV and CAC score
Vibrometer-based SSN-femoral PWV in relation to coronary artery calcium (CAC) score.
The CAC score is a measure of amount of calcified plaque in the coronary arteries, measured using CCTA. The CAC score is associated with increased coronary artery disease risk and future cardiovascular events.
Measured: Typically within 2 months of enrolment
Machine learning analysis of Vibrometer signals
Change in area under receiver operating curve (ROC) to predict CAD-RADS ≥2 when adding machine-learning interpretation of the Vibriometry-signal to models based on traditional risk factors for coronary artery disease.
Measured: Typically within 2 months of enrolment
Correlation between vibrometer-based PWV and left ventricular mass index
Vibrometer-based SSN-femoral PWV in relation to left ventricular mass index (LVMI), as assessed by echocardiography.
LVMI is the left ventricular mass indexed by the total body surface area, it has been associated with coronary artery disease events.
Measured: Same day as enrolment
Correlation between vibrometer-based left ventricular ejection time and left ventricular ejection fraction
Vibrometer-based left ventricular ejection time (LVET), derived by quantifying aortic valve opening and closure at the SSN, in relation to left ventricular ejection fraction (LVEF).
Measured: Same day as enrolment
Correlation between vibrometer-based PEP/LVET ratio and LVEF
Ratio of vibrometer-based pre-ejection period (PEP) and LVET in relation to LVEF.
PEP is the time from depolarization to aortic opening, LVET is the timing from aortic opening to closure. The ratio is associated with cardiovascular outcomes, such as heart failure.
Measured: Same day as enrolment
Machine learning analysis of Vibrometer signals
Machine learning analysis of vibrometry signals to predict LVEF.
Measured: Same day as enrolment
Correlation between vibrometer-based LVET and degree of aortic stenosis
Vibrometer-derived LVET in relation to degree of aortic stenosis, where degree of stenosis is assessed by echocardiography as a score 0-4 (0 = no sign, 4 = severe). The alternative to use DVI ratio instead of this score will also be evaluated.
Measured: Same day as enrolment
Correlation between vibrometer-based PEP/LVET ratio and degree of aortic stenosis
Vibrometer-derived PEP/LVET ratio in relation to degree of aortic stenosis, where degree of stenosis is assessed by echocardiography as a score 0-4 (0 = no sign, 4 = severe). The alternative to use doppler velocity index (DVI) instead of this score will also be evaluated.
DVI is a doppler echocardiographic index, it is in the context of aortic stenosis calculated as the ratio of maximum velocity across the left ventricular outflow tract (LVOT) and the maximum velocity across the aortic valve obtained by continuous-wave doppler. It is a dimensionless index.
Measured: Same day as enrolment
Correlation between vibrometer-based LVET and degree of aortic valve calcification
Vibrometer-based LVET in relation to degree of aortic valve calcification, where degree of calcification is assessed by X-ray computed tomography (CT) as a standardised score.
Measured: Same day as enrolment
Correlation between vibrometer-based PEP/LVET and degree of aortic valve calcification
Vibrometer-based PEP/LVET ratio in relation to degree of aortic valve calcification, where degree of calcification is assessed by X-ray CT as a standardised score.
Measured: Same day as enrolment
Correlation between vibrometer-based LVET and markers of diastolic dysfunction
Vibrometer-based LVET in relation to diastolic dysfunction, assessed by E/é, left ventricular mass index (LVMI) and left atrial volume (LAVi) from echocardiography.
E/é is the ratio between early mitral inflow velocity and mitral annular early diastolic velocity.
LVMI is the mass of the left ventricle indexed by the body surface area.
LAVi is the left atrial volume indexed by the body surface area.
All are dimensionless ratios which are associated with severity of diastolic dysfunction.
Measured: Same day as enrolment
Correlation between vibrometer-based PEP/LVET markers of diastolic dysfunction
Vibrometer-based PEP/LVET ratio in relation to diastolic dysfunction, assessed by E/é, LVMI and left atrial volume from echocardiography.
Measured: Same day as enrolment
Machine learning analysis of Vibrometer signals
Machine learning analysis of Vibrometer signals to predict the degree of diastolic dysfunction (grade 1-5).
Measured: Same day as enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Jul 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies 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
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HJN Sverige AB/Neko Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Professor Jonas Spaak, MD, PhD, Principal investigator, Karolinska Institute, Department of Clinical Sciences, Danderyd Hospital, Division of Cardiovascular Medicine, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001007
- Sponsor's protocol ID
- CRD-P4-LMV_CIP-240116
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCAPIS 2 Cardio - Vibrometer Based Pulse Wave Analysis and CVD Risk Assessment
- ClinicalTrials.gov ID
- NCT07001007
- Acronym / sponsor ID
- CRD-P4-LMV_CIP-240116
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- HJN Sverige AB/Neko HealthIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 3 Jun 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 pulse wave characteristics and explore its potential in assessment of coronary artery disease, aortic stenosis and heart failure, in a population-based sample aged 58-72 years.
It will be the first in clinical setting, pilot stage, observational investigation to evaluate the clinical safety, performance and diagnostic accuracy of Cardio P4, a laser-doppler vibrometry (LDV) and microwave radar-based device.
Detailed description
Cardiovascular disease (CVD) is the leading cause of death globally, placing a large burden on the healthcare system.
In asymptomatic individuals, there exists several risk scores to predict cardiovascular events (like SCORE2, SCORE2-OP and Framinham Risk Score). In patients with suspected symptoms of coronary artery disease, the European Society of Cardiology advice to estimate the pre-test probability by the risk factor-weighted clinical likelihood (RF-CL).
Most of these scores include the key factors for CAD development including age, sex, LDL- (or non-HDL) cholesterol, diabetes, smoking history, blood pressure or hypertension. Coronary computed tomography angiography (CCTA) is one of the main recommended examinations at low-intermediary risk based on PTP. While the procedure is non-invasive and relatively safe in comparison to invasive alternatives, they still represent a risk to the patient by radiation exposure and incidental findings, and is associated with lack of availability.
One key issue is that once a patient has a CCTA performed showing coronary atherosclerosis, that entails optimized prevention, with solid evidence. However, patients without symptoms of CAD are less studied regarding the degree of CAD. The present SCAPIS trial is the largest such trial on CCTA in 30 000 patients age 50 to 64 years, 25 182 individuals without known coronary heart disease were included. In these asymptomatic persons, CCTA-detected atherosclerosis was found in 42.1% and a significant stenosis (≥50%) in 5.2%.
Arterial stiffness, commonly assessed as pulse wave velocity (PWV), is a marker of aging of the cardiovascular system, and is independently associated with coronary artery disease. Increased arterial stiffness is an early indicator of cardiovascular disease and may improve precision in risk stratification. Laser-Doppler and microwave radar are new promising methods for analysis of pulse waves in human blood vessels. The technology may be more suitable for screening through enabling lower operator dependence and faster assessment time in comparison to standard assessment methods, and may contribute to lower overall healthcare costs and improved precision in identification of CVD.
Analysis of the pulse waveform characteristics such as time intervals and acceleration may in addition to PWV be useful as predictors of risk. We have shown that specific features from the early phase of the waveform (amplitude ratio) are most predictive when analysing similar pressure waveforms captured from the peripheral arteries (by photoplethysmography).
Cardiac timings extracted from a pulse waveform such as left ventricular ejection time and pre-ejection period are independent predictors of diseases such as aortic valve stenosis and heart failure, and may provide an effective method for risk estimation. The most common methods today for diagnosis of cardiac disease (such as aortic stenosis, heart failure) include laboratory tests, assessment of symptoms and echocardiography. Echocardiography is non-invasive, but has high reliance on operator skill which may cause variability in image acquisition and interpretation.
Machine-learning of many waveform features simultaneously, or feature-less analysis using neural networks and language-model driven analysis, may further improve the prediction.
The main aim of the study is to evaluate the potential value of a novel laser-radar-based vibrometer technology that can measure among several features arterial stiffness, and its possible role to improve risk stratification of coronary artery disease.
Secondary aims include to evaluate cardiac timings using laser doppler vibrometry for a possible role to improve risk stratification of patients with aortic stenosis and systolic or diastolic dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCAPIS2_cohort | – | Diagnostic Test: Coronary Computer Tomography (CCTA), Other: Laser Doppler Vibrometry and single-lead ECG, Device: Echocardiography, Device: Pulse Wave VelocityIn SCAPIS (2014 -2018) 30.000 randomly selected adults between the ages of 50 - 64 were included. SCAPIS 2 is the re-assessment study of half of the original study cohort. In Stockholm (Danderyd Hospital site) that corresponds to 2500 adults (that are now between 6-10 years older than the first SCAPIS study). The present study described in this CIP is a prospective, observational substudy of SCAPIS 2, done in collaboration with Karolinska Institutet (KIDS) and Danderyd Hospital. |
Who may qualify
- Ages
- 58 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In SCAPIS (2014 -2018) 30.000 randomly selected adults between the ages of 50 - 64 were included. SCAPIS 2 is the re-assessment study of half of the original study cohort. In Stockholm (Danderyd Hospital site) that corresponds to 2500 adults (that are now between 6-10 years older than the first SCAPIS study). The present study described in this CIP is a prospective, observational substudy of SCAPIS 2, done in collaboration with Karolinska Institutet (KIDS) and Danderyd Hospital.
Key inclusion criteria (1 listed)
- Subjects already included in the main / general SCAPIS 2 study at Danderyd Hospital in Stockholm, and of which has also participated in the echocardiography examination
Key exclusion criteria (1 listed)
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Computer Tomography (CCTA)Use of standard equipment for usual care | Diagnostic test | SCAPIS2_cohort |
| Laser Doppler Vibrometry and single-lead ECGPhysiological data acquisition equipment | Other | SCAPIS2_cohort |
| EchocardiographyGE Vivid E95 | Device | SCAPIS2_cohort |
| Pulse Wave VelocityArteriograph, Tensiomed, Hungary | Device | SCAPIS2_cohort |
Primary outcome
Area under receiver operating curve (ROC) to predict CAD-RADS ≥2
Time frame: Typically within 2 months of enrolment
Change in area under receiver operating curve (ROC) to predict CAD-RADS ≥2 when adding Vibrometer-based SSN femoral PWV to the standard risk factors. Coronary artery disease reporting and data system (CAD-RADS) ≥2 refers to the classification of coronary artery disease with at least moderate stenosis as identified on coronary computer tomography angiography. The classification follows the CAD-RADS 2.0 definition. Stenosis is graded in severity from 0-5.
20 secondary outcomes
Area under receiver operating curve (ROC) to predict CAD-RADS ≥3
Time frame: Typically within 2 months of enrolment
Area under receiver operating curve (ROC) to predict CAD-RADS ≥2
Time frame: Typically within 2 months of enrolment
Area under receiver operating curve (ROC) to predict CAD-RADS ≥2 stratified by sex
Time frame: Typically within 2 months of enrolment
Area under receiver operating curve (ROC) to predict CAD-RADS ≥2 stratified by body mass index strata
Time frame: Typically within 2 months of enrolment
Correlation between vibrometer-based PWA from the suprasternal notch and PWV by Arteriograph
Time frame: Typically within 2 months of enrolment
Correlation between vibrometer-based PWA from the suprasternal notch and CAD-RADS score
Time frame: Typically within 2 months of enrolment
Correlation between pressure sensor (piezo) based PWV and CAD-RADS score
Time frame: Typically within 2 months of enrolment
Correlation between vibrometer-based PWV and CAC score
Time frame: Typically within 2 months of enrolment
Machine learning analysis of Vibrometer signals
Time frame: Typically within 2 months of enrolment
Correlation between vibrometer-based PWV and left ventricular mass index
Time frame: Same day as enrolment
Correlation between vibrometer-based left ventricular ejection time and left ventricular ejection fraction
Time frame: Same day as enrolment
Correlation between vibrometer-based PEP/LVET ratio and LVEF
Time frame: Same day as enrolment
Machine learning analysis of Vibrometer signals
Time frame: Same day as enrolment
Correlation between vibrometer-based LVET and degree of aortic stenosis
Time frame: Same day as enrolment
Correlation between vibrometer-based PEP/LVET ratio and degree of aortic stenosis
Time frame: Same day as enrolment
Correlation between vibrometer-based LVET and degree of aortic valve calcification
Time frame: Same day as enrolment
Correlation between vibrometer-based PEP/LVET and degree of aortic valve calcification
Time frame: Same day as enrolment
Correlation between vibrometer-based LVET and markers of diastolic dysfunction
Time frame: Same day as enrolment
Correlation between vibrometer-based PEP/LVET markers of diastolic dysfunction
Time frame: Same day as enrolment
Machine learning analysis of Vibrometer signals
Time frame: Same day as 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 3 Jun 2025.
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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.
Professor Jonas Spaak, MD, PhD principal investigator
Karolinska Institute, Department of Clinical Sciences, Danderyd Hospital, Division of Cardiovascular Medicine, Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arterial Disease (CAD) and Arterial Stiffness, run by HJN Sverige AB/Neko Health at 1 site 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 1 inclusion and 1 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 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (+46703169040, mattias@nekohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under receiver operating curve (ROC) to predict CAD-RADS ≥2 (time frame: Typically within 2 months of enrolment). 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 3 Jun 2025.