Non-invasive Microvascular Assessment in Individuals at High Risk of Cardiovascular Disease From the SCAPIS2 Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHJN Sverige AB/Neko Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Scarring, tattoos, or amputations that preclude device examination
Cohort specific exclusion criteria apply, as stated in 'groups' section
Trial population
SCAPIS 2 General cohort
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
900 Participants
are grouped into 4 trial groupsGroup A: O-CAD
Group B: ANOCA
Group C: Metabolic
Group D: Left ventricular diastolic dysfunction
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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).
Time frame
Baseline3
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
Time frame
Baseline4
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..
Time frame
Baseline and at stress cardiac MRI- visit within 3 monthsSecondary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Baseline3
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.
Time frame
Baseline4
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.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov