Assessing arterial stiffness and heart disease risk using a novel technology
Cardio Alpha - Vibrometer Based Pulse Wave Analysis for Arterial Stiffness and Ischemic Heart Disease Risk Assessment
This study is testing a new, no-touch technology to measure how stiff your arteries are and see if it can help figure out your risk for heart disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 8000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HJN Sverige AB/Neko Health Industry-sponsored |
| Locations | 3 sites (Stockholm and 2 other locations) |
| Trial ID | NCT06984211 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates a new contactless technology for measuring arterial stiffness and its potential in assessing cardiovascular disease risk. The study focuses on a primary care cohort, utilizing a laser-radar-based vibrometer to gather data on arterial stiffness and cardiovascular health. Participants will undergo various assessments, including blood pressure measurements and ECG, with additional investigations for those at higher risk of cardiovascular issues. The aim is to improve the precision of cardiovascular disease risk assessment through a multi-modal approach.
Who should consider this trial
Good fit: Ideal candidates include adult patients within the regular healthcare flow at the investigational sites who can provide informed consent.
Not a fit: Patients with cognitive impairments or severe terminal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of cardiovascular disease risk, potentially improving patient outcomes.
How similar studies have performed: While the approach is innovative, similar studies have shown promise in assessing cardiovascular risk using non-invasive methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Adult patients that are part of the regular healthcare patient flow at the investigational sites, or as separately invited to participate in this investigation. * Patients with signed informed consent Exclusion criteria: * Cognitive impairment * Patients unable to understand the oral and written study information in Swedish or English * Other severe disorder or terminal disease, e.g. infection/sepsis, severe COPD or metastatic cancers. * Patients unable to provide an informed consent
Where this trial is running
Stockholm and 2 other locations
- Atrium Health Care Centre — Stockholm, Sweden (Recruiting)
- Neko Health Centre, Regeringsgatan — Stockholm, Sweden (Recruiting)
- Neko Health Centre, Sibyllegatan — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Henrik Hellqvist, MD — Neko Health AB
- Study coordinator: Mattias Windå, MSc
- 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.