RecruitingNCT06984211

Vibrometer Based Pulse Wave Analysis for Arterial Stiffness and Ischemic Heart Disease Risk Assessment

Cardio Alpha - Vibrometer Based Pulse Wave Analysis for Arterial Stiffness and Ischemic Heart Disease Risk Assessment


Sponsor

HJN Sverige AB/Neko Health

Enrollment

8,000 participants

Start Date

Feb 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

This clinical investigation will evaluate a novel contactless technology for assessing arterial stiffness and explore its potential in assessment of risk for and development of cardiovascular disease. The main aims of the study are: 1. To assess device and method performance for assessment of arterial stiffness and cardiovascular risk, on a prospective primary care cohort. 2. To see if precision may be added in CVD risk assessment through a multi-modal approach, combining data on macro- and micro-circulatory function.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new device that measures pulse wave velocity (how fast a pressure wave travels through your arteries) using a small vibrating sensor held gently against the skin — similar to how a tuning fork works. Stiffer arteries are linked to higher risk of heart attack, and this tool may offer an easier way to assess that risk without complex procedures. **You may be eligible if...** - You are an adult patient receiving routine care at one of the study clinics, or have been separately invited to participate - You are able to understand the study information (in Swedish or English) and give consent **You may NOT be eligible if...** - You have cognitive impairment that prevents understanding the study - You cannot communicate in Swedish or English - You have a severe or terminal illness (such as active sepsis, severe COPD, or metastatic cancer) that makes participation unsafe Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.


Locations(3)

Atrium Health Care Centre

Stockholm, Sweden

Neko Health Centre, Regeringsgatan

Stockholm, Sweden

Neko Health Centre, Sibyllegatan

Stockholm, Sweden

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NCT06984211


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