Non-invasive testing of skin and heart microvascular function in older adults at high cardiovascular risk.
SCAPIS 2 - Spectrum Study -CVD Risk Based on Microvascular Dysfunction
This project will try non-invasive skin imaging and cardiac MRI methods to find early microvascular problems in adults aged 60–75 who are at high risk of cardiovascular disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Sex | All |
| Sponsor | HJN Sverige AB/Neko Health Industry-sponsored |
| Locations | 1 site (Stockholm, Danderyd) |
| Trial ID | NCT07359768 on ClinicalTrials.gov |
What this trial studies
SCAPIS 2 Spectrum is a prospective observational sub-study enrolling about 900 SCAPIS participants aged 60–75 across five high‑risk arms (obstructive CAD, ANOCA, metabolic syndrome with diabetes, left ventricular systolic dysfunction, and left ventricular diastolic dysfunction). The study applies three investigational dermal perfusion devices — Perimed Periflux 6000 EPOS (DRS + LDF), PeriCam MultiFlow (MELSCI + MSI), and the TCI P4 (spatial frequency domain imaging) — combined with functional provocations such as post‑occlusive reactive hyperemia, flow‑motion analysis, and thermal provocation. Cardiac microvascular function is measured using adenosine stress cardiac magnetic resonance with first‑pass perfusion and quantitative myocardial blood flow to derive myocardial perfusion reserve. The goal is to link skin microcirculation signals with cardiac microvascular metrics to identify subclinical systemic microvascular dysfunction.
Who should consider this trial
Good fit: Ideal candidates are SCAPIS participants aged 60–75 who were invited to SCAPIS2, meet one of the five specified high‑risk cohort definitions, and can undergo skin imaging and adenosine stress CMR.
Not a fit: Patients with skin scarring, tattoos, or amputations that prevent device measurements, or those who cannot undergo CMR (for example due to incompatible implants, contrast/adenosine contraindications, or severe claustrophobia), are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, these non-invasive tests could detect early microvascular dysfunction and enable earlier interventions to prevent progression to overt cardiovascular disease.
How similar studies have performed: Previous research using non-invasive microvascular imaging and CMR perfusion has shown promise in detecting microvascular abnormalities, but the combined multi-device approach remains relatively novel and not yet established for routine clinical use.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stockholm, Danderyd
- Danderyd Hospital — Stockholm, Danderyd, Sweden (Recruiting)
Study contacts
- Study coordinator: Mattias Windå, Chief Science and Innovation Officer
- Email: mattias@nekohealth.com
- Phone: +46703169040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.