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

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

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Overview

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.

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.

Eligibility

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Scarring, tattoos, or amputations that preclude device examination
  • Cohort specific exclusion criteria apply, as stated in 'groups' section

Study details
    Cardiovascular Diseases
    Microvascular Complications

NCT07359768

HJN Sverige AB/Neko Health

31 January 2026

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