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

HJN Sverige AB/Neko Health

Status: Enrolling

Conditions: Microvascular Complications; Cardiovascular Diseases

Study type: Observational

Funder types: Industry

Identifiers

NCT07359768

CIV-23-12-045355 (Other Identifier)

2024-01937-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

900 participants in 4 patient groups

O-CAD

Description:

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

Description:

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

Description:

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

Description:

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.