Contactless vibrometer pulse‑wave test for heart and artery health
Official title: SCAPIS 2 Cardio - Vibrometer Based Pulse Wave Analysis and CVD Risk Assessment
Run by HJN Sverige AB/Neko Health · NCT07001007 · Data updated 2026-11-12
This pilot will try a contactless laser‑Doppler vibrometry and microwave radar device (Cardio P4) in people aged 58–72 to see if it can detect arterial stiffness and signs of coronary artery disease, aortic stenosis, or heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 58 Years to 72 Years |
| Sex | All |
| Enrollment | 1600 (estimated) |
| Sponsor | HJN Sverige AB/Neko Health Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Stockholm) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | June 3, 2025 |
| Trial ID | NCT07001007 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are SCAPIS 2 participants at Danderyds Hospital aged about 58–72 who have already completed the SCAPIS echocardiography exam and can give informed consent.
✕Probably not a fit
People who are not enrolled in the local SCAPIS cohort, cannot provide informed consent, or need urgent evaluation for known acute cardiac disease are unlikely to benefit from this pilot.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational pilot uses Cardio P4, a contactless laser‑Doppler vibrometry and microwave radar system, in a population‑based sample drawn from the SCAPIS cohort aged 58–72. Participants who previously completed SCAPIS echocardiography will undergo Cardio P4 recordings alongside single‑lead ECG, pulse wave velocity measurements, and comparison with echocardiography and, when available, coronary CT angiography. The study will collect safety data and measure device performance and diagnostic accuracy against established imaging and physiological measures. Findings will determine whether contactless pulse‑wave analysis can serve as a noninvasive screening or risk‑stratification tool.
Why it matters
Potential benefit: If successful, the device could provide a quick, contactless way to screen for arterial stiffness and early heart or valve disease, potentially reducing reliance on radiation‑based imaging.
How similar studies have gone: Pulse‑wave analysis and pulse‑wave velocity have established links to cardiovascular risk, but the Cardio P4 contactless LDV and microwave radar approach is a first‑in‑clinic pilot and remains novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects already included in the main / general SCAPIS 2 study at Danderyd Hospital in Stockholm, and of which has also participated in the echocardiography examination Exclusion Criteria: * Patients unable to provide an informed consent
Where it's running
-
Danderyds Hospital, KFC - Hjärt-kärllaboratoriet
Stockholm, Sweden Recruiting
Study contacts
- Principal investigator: Professor Jonas Spaak, MD, PhD — Karolinska Institute, Department of Clinical Sciences, Danderyd Hospital, Division of Cardiovascular Medicine, Stockholm, Sweden
- Study coordinator: Mattias Windå
- 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.