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

Official title

SCAPIS 2 - Spectrum Study -CVD Risk Based on Microvascular Dysfunction

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.

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.

Primary outcome measures

• Correlation between device-derived skin microcirculation variables and CCTA severity metrics including CAD-RADS (0-5) and plaque burden [Time frame: Baseline]
• Discriminative performance of device-derived microcirculatory variables for significant coronary stenosis [Time frame: Baseline]
• 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]
• 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]
• Proportion of ANOCA participants who have INOCA [Time frame: Baseline and at stress cardiac MRI- visit within 3 months]
• 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]
• Correlation between investigational device variables and presence of Coronary Microvascular Dysfunction (CMD). [Time frame: Baseline and at stress cardiac MRI- visit within 3 months]
• Correlation of skin microcirculation variables with echocardiographic marker for diastolic function [Time frame: Baseline]
• Association of skin microcirculation variables with elevated echocardiographic marker for diastolic dysfunction. [Time frame: Baseline]
• Correlation of skin microcirculation variables with biomarker for cardiac stress [Time frame: Baseline]

Secondary outcome measures (4)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Sweden · 1 center

• Danderyd Hospital — Stockholm

Identifiers

NCT: NCT07359768 · 2024-01937-01 · CIV-23-12-045355

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗