Actively Recruiting
Non-invasive Microvascular Assessment in Individuals at High Risk of Cardiovascular Disease From the SCAPIS2 Study
Led by HJN Sverige AB/Neko Health · Updated on 2026-01-22
900
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Non-invasive Microvascular Assessment in Individuals at High Risk of Cardiovascular Disease From the SCAPIS2 Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participated in the SCAPIS baseline study approximately 10 years ago
- Meets group-specific inclusion criteria as defined in the study
- Has been invited to SCAPIS 2 core and provided signed informed consent
You will not qualify if you...
- Scarring, tattoos, or amputations that prevent device examination
- Meets group-specific exclusion criteria as defined in the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Danderyd Hospital
Stockholm, Danderyd, Sweden
Actively Recruiting
Research Team
M
Mattias Windå, Chief Science and Innovation Officer
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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