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

Recruiting now

Conditions studied: Cardiovascular Diseases, Microvascular Complications

In brief

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.

Key facts

Study ID

NCT07359768

Run by

HJN Sverige AB/Neko Health

People needed

900

Starts

2024-03-18

Expected to finish

2026-12-29

Last updated by the study team

2026-01-22

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Danderyd Hospital — Stockholm, Danderyd, Sweden (enrolling)

Full record on ClinicalTrials.gov

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