RecruitingNCT07359768

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

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


Sponsor

HJN Sverige AB/Neko Health

Enrollment

900 participants

Start Date

Mar 18, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Inclusion Criteria2

  • 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

Exclusion Criteria1

  • Scarring, tattoos, or amputations that preclude device examination

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Locations(1)

Danderyd Hospital

Stockholm, Danderyd, Sweden

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NCT07359768


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