Cardiovascular DiseasesNCT07359768
Non-invasive Microvascular Assessment in Individuals at High Risk of Cardiovascular Disease From the SCAPIS2 Study
An observational study of Cardiovascular Diseases and Microvascular Complications, run by HJN Sverige AB/Neko Health at 1 site in Sweden.
Trial summary
Microvascular dysfunction, particularly endothelial dysfunction, is increasingly recognized as a key mechanism underlying various cardiovascular diseases (CVD), including heart failure, ischemic heart disease, atherosclerosis, stroke, dementia, and kidney failure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Microvascular Complications
- How many people
- 900 participants
- Where
- 1 siteSweden
- Study dates
- 18 Mar 2024to 29 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: SCAPIS 2 General cohort
Who may be able to join
- Participated in the SCAPIS baseline (SCAPIS 1 study, 10 years ago)
- Cohort specific inclusion criteria apply, as stated in 'groups' section
- Has been invited to SCAPIS 2 core Singed informed consent to SCAPIS 2 core
Who cannot join
- Scarring, tattoos, or amputations that preclude device examination
- Cohort specific exclusion criteria apply, as stated in 'groups' section
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
Danderyd Hospital
Stockholm, Danderyd
Sara Tehrani, Principal Investigator, MD, Ph.D, +46736797074, sara.tehrani@regionstockholm.se
About this study
Official title: SCAPIS 2 - Spectrum Study -CVD Risk Based on Microvascular Dysfunction
Microvascular dysfunction, particularly endothelial dysfunction, is increasingly recognized as a key mechanism underlying various cardiovascular diseases (CVD), including heart failure, ischemic heart disease, atherosclerosis, stroke, dementia, and kidney failure. Chronic low-grade inflammation linked to metabolic syndrome may further drive systemic microvascular impairment. Early detection of these subclinical processes using non-invasive assessments could facilitate timely interventions to prevent disease progression.
SCAPIS 2 Spectrum is a prospective observational sub-study of the Swedish Cardiopulmonary Bioimage Study (SCAPIS-2), recruiting approximately 900 subjects aged 60-75 years. The study is organized into five arms-obstructive coronary artery disease (O-CAD), angina with nonobstructive coronary arteries (ANOCA), metabolic syndrome with diabetes, left ventricular systolic dysfunction, and left ventricular diastolic dysfunction-each defined by specific inclusion and exclusion criteria. Participants will undergo a comprehensive microvascular assessment using investigational devices (including Perimed Periflux EPOS, PeriCam MultiFlow, and TCI P4) alongside stress cardiac magnetic resonance imaging (stress-CMR) for cardiac-specific evaluation.
Read the detailed description
Non-invasive microvascular Assessment A comprehensive microvascular evaluation is performed using three investigational devices designed to capture detailed information on dermal perfusion. The Perimed Periflux 6000 EPOS employs diffuse reflectance spectroscopy (DRS) and laser Doppler flowmetry (LDF) for a single-point multi-modal assessment. The PeriCam MultiFlow performs imaging of dermal perfusion using multi-exposure laser contrast imaging (MELSCI) and measures blood oxygen saturation via multispectral imaging (MSI). Additionally, the TCI P4 utilizes spatial frequency domain imaging technology for quantification of perfusion and chromophore concentrations in the skin. Functional methods, including Post-Occlusive Reactive Hyperemia (PORH), Flow-Motion Analysis, and Thermal Provocation, are applied to assess dynamic microvascular responses.
Cardiac Magnetic Resonance Imaging (CMR) Stress#CMR is conducted using adenosine infusion and contrast enhancement to evaluate cardiac-specific microvascular function. This approach includes first-pass perfusion imaging and quantitative myocardial blood flow analyses, which allow for calculation of myocardial perfusion reserve.
- Keywords
- microvascular, non-invasive, microcirculation, spatial frequency domain imaging, cardiac magnetic resonance imaging, laser speckle contrast imaging, laser doppler flowmetry
- Medical subject headings
- Cardiovascular Diseases
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 |
|---|---|---|
| O-CAD | O-CAD arm inclusion is based on burden of coronary atherosclerosis measure in computer tomography of coronary arteries (CCTA) as measured by coronary artery disease reporting and data system (CADRADS). If CAD-RADS is above or equal to 3, participant may be eligible for inclusion in O-CAD arm. | |
| ANOCA | ANOCA arm inclusion is dictated by presence of cardiac angina as defined by the rose questionnaire and CAD-RADS <3. Exclusion criteria are similar as to those for stress-CMR. | |
| Metabolic | Inclusion is dictated by prevalence of diabetes mellitus concomitantly present with metabolic syndrome with metabolic syndrome severity score higher than 4. Exclusion criteria are similar as to those for stress-CMR, alongside CAD RADS < 3 and no angina as defined by rose questionnaire. | |
| Left ventricular diastolic dysfunction | Inclusion is dictated by diastolic dysfunction as defined by British Society of Echocardiography. Exclusion criteria are similar as to those for stress- CMR, alongside CAD RADS < 3 and no angina as defined by rose questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between device-derived skin microcirculation variables and CCTA severity metrics including CAD-RADS (0-5) and plaque burden
Assess the correlation between skin microcirculation parameters measured by investigational devices (icluding PORH; 42°C local heat plateau; flow-motion endothelial-band power; iontophoresis acetylcholine response), coronary CT angiography (CCTA) severity metrics: CAD-RADS score, 0-5, zero is equivalent to no plaque and 5 indicates complete occlusionan (fully blocked) and Plaque burden indices (e.g., Segment Involvement Score [SIS])
The device-derived microcirculation parameters are:
Baseline perfusion, Perfusion after provocation, Peak perfusion, Time to peak, Recovery time, Capillary recruitment and Oxygen saturation (StO₂)
The goal is to determine if these microcirculation measurements reflect coronary disease severity.
Measured: Baseline
Discriminative performance of device-derived microcirculatory variables for significant coronary stenosis
Evaluate the ability of microcirculatory variables measured by investigational devices to discriminate between patients with and without significant coronary stenosis, defined as CAD-RADS ≥ 3 (≥50% luminal narrowing on coronary CT angiography).
Measured: Baseline
Proportion of ANOCA participants (CAD-RADS <3 with angina per Rose questionnaire) who meet CMD criteria on stress-cardiac MRI using perfusion assessment
Calculate the proportion of participants classified as ANOCA (defined as CAD-RADS < 3 and angina symptoms per Rose Angina Questionnaire) who fulfill criteria for coronary microvascular dysfunction (CMD) based on stress cardiac MRI perfusion assessment according to site-standard protocols
Measured: Baseline
Proportion of INOCA participants (CAD-RADS <3 with ishemia per Rose questionnaire) who meet CMD criteria on stress-cardiac MRI using perfusion assessment.
Calculate the proportion of participants classified as INOCA (CAD-RADS < 3 and objective ischemia evidence) who fulfill CMD criteria based on stress cardiac MRI perfusion assessment..
Measured: Baseline and at stress cardiac MRI- visit within 3 months
Proportion of ANOCA participants who have INOCA
Among participants identified with ANOCA (non-obstructive coronary artery disease on CT angiography), the proportion who demonstrate myocardial ischemia (INOCA) will be calculated. Ischemia will be assessed using cardiac MRI stress perfusion imaging, which is considered the gold standard for myocardial microcirculatory dysfunction
Measured: Baseline and at stress cardiac MRI- visit within 3 months
Assess whether peripheral microvascular function reflects myocardial perfusion abnormalities in CMD and mild CAD
This outcome examines whether skin microcirculation parameters measured by investigational devices correlate with quantitative/ semiquantitative myocardial perfusion metrics obtained from stress cardiac-MRI in participants with:
Coronary Microvascular Dysfunction (CMD) Non-obstructive coronary disease (CAD-RADS <3)
Measured: Baseline and at stress cardiac MRI- visit within 3 months
Correlation between investigational device variables and presence of Coronary Microvascular Dysfunction (CMD).
Evaluate whether distinct cut-off values in device-derived microvascular parameters correlate with significant CMD. CMD will be defined by cardiac MRI stress perfusion imaging. The following variables will be assessed using investigational devices
Measured: Baseline and at stress cardiac MRI- visit within 3 months
Correlation of skin microcirculation variables with echocardiographic marker for diastolic function
Assess the general correlation between investigational device variables and E/é ratio (echocardiographic marker) to assess diastolic function.
A high E/é ratio suggests elevated left atrial pressure and impaired relaxation (diastolic dysfunction).
A low E/é ratio indicates normal filling pressures.
Measured: Baseline
Association of skin microcirculation variables with elevated echocardiographic marker for diastolic dysfunction.
Determine whether investigationnal device-derived variables correlate with E/é > 15, indicative of increased left ventricular filling pressures.
Measured: Baseline
Correlation of skin microcirculation variables with biomarker for cardiac stress
Assess general correlation between investigationnal device-derived variables and ProBNP as a biomarker of cardiac stress.
Measured: Baseline
Association of skin microcirculation variables with elevated biomarker for measuring cardiac stress
Assess general correlation between investigationnal device-derived variables s and ProBNP as a biomarker of cardiac stress.
Measured: Baseline
Identification of device variable thresholds predicting diastolic dysfunction/heart failure
Evaluate whether specific cut-off values of investigational device-derived microcirculation variables are associated with confirmed dysfunction/heart failure
Measured: Baseline and at stress cardiac MRI- visit within 3 months
Correlation of skin microcirculation variables with high levels of a biomarker for average blood glucose
Calculate the correlation between the respective variables of the investigational devices and the incidence of HbA1c being > 65 mmol/mol.
Measured: Baseline
Correlation of device-derived microcirculation variables with nephropathy
Calculate the correlation between the respective variables of the investigational devices and the incidence of nephropathy
Measured: Baseline
Correlation betweed device-derived microcirculatory variables with endothelial/glycocalyx/inflammation biomarkers
Correlation between microcirculatory variables from investigational devices and biomarker panels (thrombomodulin, circulating endothelial cells, VE-cadherin, syndecan-1, hyaluronan, hsCRP, IL-6, GlycA).
Measured: Baseline
Secondary outcomes (4)
Correlation of Myogenic Response with Cardiovascular Disease
Asses the association between myogenic response from device-derived variables and cardiovascular disease incidence; includes incidence of myogenic vs endothelial dysfunction.
Measured: Baseline
Association of Vascular Inflammation with Microcirculatory Variables
Correlation between systemic inflammation biomarkers (e.g., hsCRP, IL-6, GlycA) and device-derived microcirculatory measures; exploratory detection of early inflammatory alterations.
Measured: Baseline
Mechanisms of endothelial damage and Cardiovascular Disease devlopment
Analysis of biomarker panels (endothelial/glycocalyx damage: thrombomodulin, VE-cadherin, syndecan-1, hyaluronan) to identify progression patterns and explore the correlation with device-derived microcirculatory variables.
Measured: Baseline
Development of multi-modal Cardiovascular Disease risk score
Creation and validation of a composite risk score integrating microcirculatory variables derived from investigationa devices and biomarker data; evaluation of predictive performance for Cardiovascular Disease endpoints.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start18 Mar 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion29 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HJN Sverige AB/Neko Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359768
- Sponsor's protocol ID
- 2024-01937-01
- Other IDs
- CIV-23-12-045355
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Widaeus J, Schef KW, Jernberg T, Winda M, Salomonsson F, Johansson H, Nickander J, Brandberg H, Cronhjort M, Tehrani S. SCAPIS 2 spectrum: rationale, objectives and design of a microvascular dysfunction sub-study within the Swedish CArdioPulmonary bioImage study. Front Cardiovasc Med. 2026 Sep 24;13:1899591. doi: 10.3389/fcvm.2026.1899591. eCollection 2026.
PubMed 42851777
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCAPIS 2 - Spectrum Study -CVD Risk Based on Microvascular Dysfunction
- ClinicalTrials.gov ID
- NCT07359768
- Acronym / sponsor ID
- 2024-01937-01
- Keywords
- microvascular, non-invasive, microcirculation, spatial frequency domain imaging, cardiac magnetic resonance imaging, laser speckle contrast imaging, laser doppler flowmetry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- HJN Sverige AB/Neko HealthIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 29 Dec 2026 (estimated)
- First posted
- 22 Jan 2026 (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.
Microvascular dysfunction, particularly endothelial dysfunction, is increasingly recognized as a key mechanism underlying various cardiovascular diseases (CVD), including heart failure, ischemic heart disease, atherosclerosis, stroke, dementia, and kidney failure. Chronic low-grade inflammation linked to metabolic syndrome may further drive systemic microvascular impairment. Early detection of these subclinical processes using non-invasive assessments could facilitate timely interventions to prevent disease progression.
SCAPIS 2 Spectrum is a prospective observational sub-study of the Swedish Cardiopulmonary Bioimage Study (SCAPIS-2), recruiting approximately 900 subjects aged 60-75 years. The study is organized into five arms-obstructive coronary artery disease (O-CAD), angina with nonobstructive coronary arteries (ANOCA), metabolic syndrome with diabetes, left ventricular systolic dysfunction, and left ventricular diastolic dysfunction-each defined by specific inclusion and exclusion criteria. Participants will undergo a comprehensive microvascular assessment using investigational devices (including Perimed Periflux EPOS, PeriCam MultiFlow, and TCI P4) alongside stress cardiac magnetic resonance imaging (stress-CMR) for cardiac-specific evaluation.
Detailed description
Non-invasive microvascular Assessment A comprehensive microvascular evaluation is performed using three investigational devices designed to capture detailed information on dermal perfusion. The Perimed Periflux 6000 EPOS employs diffuse reflectance spectroscopy (DRS) and laser Doppler flowmetry (LDF) for a single-point multi-modal assessment. The PeriCam MultiFlow performs imaging of dermal perfusion using multi-exposure laser contrast imaging (MELSCI) and measures blood oxygen saturation via multispectral imaging (MSI). Additionally, the TCI P4 utilizes spatial frequency domain imaging technology for quantification of perfusion and chromophore concentrations in the skin. Functional methods, including Post-Occlusive Reactive Hyperemia (PORH), Flow-Motion Analysis, and Thermal Provocation, are applied to assess dynamic microvascular responses.
Cardiac Magnetic Resonance Imaging (CMR) Stress#CMR is conducted using adenosine infusion and contrast enhancement to evaluate cardiac-specific microvascular function. This approach includes first-pass perfusion imaging and quantitative myocardial blood flow analyses, which allow for calculation of myocardial perfusion reserve.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| O-CAD | – | –O-CAD arm inclusion is based on burden of coronary atherosclerosis measure in computer tomography of coronary arteries (CCTA) as measured by coronary artery disease reporting and data system (CADRADS). If CAD-RADS is above or equal to 3, participant may be eligible for inclusion in O-CAD arm. |
| ANOCA | – | –ANOCA arm inclusion is dictated by presence of cardiac angina as defined by the rose questionnaire and CAD-RADS <3. Exclusion criteria are similar as to those for stress-CMR. |
| Metabolic | – | –Inclusion is dictated by prevalence of diabetes mellitus concomitantly present with metabolic syndrome with metabolic syndrome severity score higher than 4. Exclusion criteria are similar as to those for stress-CMR, alongside CAD RADS < 3 and no angina as defined by rose questionnaire. |
| Left ventricular diastolic dysfunction | – | –Inclusion is dictated by diastolic dysfunction as defined by British Society of Echocardiography. Exclusion criteria are similar as to those for stress- CMR, alongside CAD RADS < 3 and no angina as defined by rose questionnaire. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- SCAPIS 2 General cohort
Key inclusion criteria (3 listed)
- Participated in the SCAPIS baseline (SCAPIS 1 study, 10 years ago)
- Cohort specific inclusion criteria apply, as stated in 'groups' section
- Has been invited to SCAPIS 2 core Singed informed consent to SCAPIS 2 core
Key exclusion criteria (2 listed)
- Scarring, tattoos, or amputations that preclude device examination
- Cohort specific exclusion criteria apply, as stated in 'groups' section
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 device-derived skin microcirculation variables and CCTA severity metrics including CAD-RADS (0-5) and plaque burden
Time frame: Baseline
Assess the correlation between skin microcirculation parameters measured by investigational devices (icluding PORH; 42°C local heat plateau; flow-motion endothelial-band power; iontophoresis acetylcholine response), coronary CT angiography (CCTA) severity metrics: CAD-RADS score, 0-5, zero is equivalent to no plaque and 5 indicates complete occlusionan (fully blocked) and Plaque burden indices (e.g., Segment Involvement Score [SIS]) The device-derived microcirculation parameters are: Baseline perfusion, Perfusion after provocation, Peak perfusion, Time to peak, Recovery time, Capillary recruitment and Oxygen saturation (StO₂) The goal is to determine if these microcirculation measurements reflect coronary disease severity.
Discriminative performance of device-derived microcirculatory variables for significant coronary stenosis
Time frame: Baseline
Evaluate the ability of microcirculatory variables measured by investigational devices to discriminate between patients with and without significant coronary stenosis, defined as CAD-RADS ≥ 3 (≥50% luminal narrowing on coronary CT angiography).
Proportion of ANOCA participants (CAD-RADS <3 with angina per Rose questionnaire) who meet CMD criteria on stress-cardiac MRI using perfusion assessment
Time frame: Baseline
Calculate the proportion of participants classified as ANOCA (defined as CAD-RADS < 3 and angina symptoms per Rose Angina Questionnaire) who fulfill criteria for coronary microvascular dysfunction (CMD) based on stress cardiac MRI perfusion assessment according to site-standard protocols
Proportion of INOCA participants (CAD-RADS <3 with ishemia per Rose questionnaire) who meet CMD criteria on stress-cardiac MRI using perfusion assessment.
Time frame: Baseline and at stress cardiac MRI- visit within 3 months
Calculate the proportion of participants classified as INOCA (CAD-RADS < 3 and objective ischemia evidence) who fulfill CMD criteria based on stress cardiac MRI perfusion assessment..
Proportion of ANOCA participants who have INOCA
Time frame: Baseline and at stress cardiac MRI- visit within 3 months
Among participants identified with ANOCA (non-obstructive coronary artery disease on CT angiography), the proportion who demonstrate myocardial ischemia (INOCA) will be calculated. Ischemia will be assessed using cardiac MRI stress perfusion imaging, which is considered the gold standard for myocardial microcirculatory dysfunction
Assess whether peripheral microvascular function reflects myocardial perfusion abnormalities in CMD and mild CAD
Time frame: Baseline and at stress cardiac MRI- visit within 3 months
This outcome examines whether skin microcirculation parameters measured by investigational devices correlate with quantitative/ semiquantitative myocardial perfusion metrics obtained from stress cardiac-MRI in participants with: Coronary Microvascular Dysfunction (CMD) Non-obstructive coronary disease (CAD-RADS <3)
Correlation between investigational device variables and presence of Coronary Microvascular Dysfunction (CMD).
Time frame: Baseline and at stress cardiac MRI- visit within 3 months
Evaluate whether distinct cut-off values in device-derived microvascular parameters correlate with significant CMD. CMD will be defined by cardiac MRI stress perfusion imaging. The following variables will be assessed using investigational devices
Correlation of skin microcirculation variables with echocardiographic marker for diastolic function
Time frame: Baseline
Assess the general correlation between investigational device variables and E/é ratio (echocardiographic marker) to assess diastolic function. A high E/é ratio suggests elevated left atrial pressure and impaired relaxation (diastolic dysfunction). A low E/é ratio indicates normal filling pressures.
Association of skin microcirculation variables with elevated echocardiographic marker for diastolic dysfunction.
Time frame: Baseline
Determine whether investigationnal device-derived variables correlate with E/é > 15, indicative of increased left ventricular filling pressures.
Correlation of skin microcirculation variables with biomarker for cardiac stress
Time frame: Baseline
Assess general correlation between investigationnal device-derived variables and ProBNP as a biomarker of cardiac stress.
Association of skin microcirculation variables with elevated biomarker for measuring cardiac stress
Time frame: Baseline
Assess general correlation between investigationnal device-derived variables s and ProBNP as a biomarker of cardiac stress.
Identification of device variable thresholds predicting diastolic dysfunction/heart failure
Time frame: Baseline and at stress cardiac MRI- visit within 3 months
Evaluate whether specific cut-off values of investigational device-derived microcirculation variables are associated with confirmed dysfunction/heart failure
Correlation of skin microcirculation variables with high levels of a biomarker for average blood glucose
Time frame: Baseline
Calculate the correlation between the respective variables of the investigational devices and the incidence of HbA1c being > 65 mmol/mol.
Correlation of device-derived microcirculation variables with nephropathy
Time frame: Baseline
Calculate the correlation between the respective variables of the investigational devices and the incidence of nephropathy
Correlation betweed device-derived microcirculatory variables with endothelial/glycocalyx/inflammation biomarkers
Time frame: Baseline
Correlation between microcirculatory variables from investigational devices and biomarker panels (thrombomodulin, circulating endothelial cells, VE-cadherin, syndecan-1, hyaluronan, hsCRP, IL-6, GlycA).
4 secondary outcomes
Correlation of Myogenic Response with Cardiovascular Disease
Time frame: Baseline
Association of Vascular Inflammation with Microcirculatory Variables
Time frame: Baseline
Mechanisms of endothelial damage and Cardiovascular Disease devlopment
Time frame: Baseline
Development of multi-modal Cardiovascular Disease risk score
Time frame: Baseline
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 Jan 2026.
- Derived from this study: PubMed 42851777Widaeus J, Schef KW, Jernberg T, Winda M, Salomonsson F, Johansson H, Nickander J, Brandberg H, Cronhjort M, Tehrani S. SCAPIS 2 spectrum: rationale, objectives and design of a microvascular dysfunction sub-study within the Swedish CArdioPulmonary bioImage study. Front Cardiovasc Med. 2026 Sep 24;13:1899591. doi: 10.3389/fcvm.2026.1899591. eCollection 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
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 Cardiovascular Diseases and Microvascular Complications, 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 3 inclusion and 2 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 Jan 2026. 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, Chief Science and Innovation Officer (+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 device-derived skin microcirculation variables and CCTA severity metrics including CAD-RADS (0-5) and plaque burden (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07359768, which also lists 1 linked publication.
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 Jan 2026.