Non-invasive testing of skin and heart microvascular function in older adults at high cardiovascular risk.
Official title: SCAPIS 2 - Spectrum Study -CVD Risk Based on Microvascular Dysfunction
Run by HJN Sverige AB/Neko Health · NCT07359768 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 900 (estimated) |
| Sponsor | HJN Sverige AB/Neko Health Industry-sponsored |
| Locations | 1 site (Stockholm, Danderyd) |
| Status | Recruiting |
| Started | March 18, 2024 |
| Main results expected | June 1, 2026 |
| Study ends | December 29, 2026 |
| Registry record updated | January 22, 2026 |
| Trial ID | NCT07359768 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Danderyd Hospital
Stockholm, Danderyd, Sweden Recruiting
Study contacts
- Study coordinator: Mattias Windå, Chief Science and Innovation Officer
- Email: mattias@nekohealth.com
- Phone: +46703169040
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.