Non-invasive Microvascular Assessment in Individuals at High Risk of Cardiovascular Disease From the SCAPIS2 Study

NCT07359768 | Recruiting

• 2 other identifiers: 2024-01937-01CIV-23-12-045355
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiovascular Diseases; Microvascular Complications

Keywords

microvascular; non-invasive; microcirculation; spatial frequency domain imaging; cardiac magnetic resonance imaging; laser speckle contrast imaging; laser doppler flowmetry

Outcome Measures

Primary Outcomes (15)

• 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.

  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).

  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

  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..

  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

  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)

  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

  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.

  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.

  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.

  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.

  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

  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.

  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

  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).

  Baseline

Secondary Outcomes (4)

• Correlation of Myogenic Response with Cardiovascular Disease

  Baseline

• Association of Vascular Inflammation with Microcirculatory Variables

  Baseline

• Mechanisms of endothelial damage and Cardiovascular Disease devlopment

  Baseline

• Development of multi-modal Cardiovascular Disease risk score

  Baseline

Study Arms (4)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SCAPIS 2 General cohort

You may qualify if:

• Participated in the SCAPIS baseline (SCAPIS 1 study, 10 years ago)
• Has been invited to SCAPIS 2 core Singed informed consent to SCAPIS 2 core

You may not qualify if:

• Scarring, tattoos, or amputations that preclude device examination

Sponsors & Collaborators

• HJN Sverige AB/Neko Health: lead

Study Sites (1)

Danderyd Hospital

Stockholm, Danderyd, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and serum samples. Approximately 25 ml of blood will be collected for analysis of various markers relevant to the study objectives, such as variables that may be associated with vascular function, inflammation, and metabolism.

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Mattias Windå, Chief Science and Innovation Officer

CONTACT

+46703169040; mattias@nekohealth.com

Study Design

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

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 22, 2026
• Study Start: March 18, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 29, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

SE (1)