RecruitingNCT07001007

SCAPIS 2 Cardio - Vibrometer Based Pulse Wave Analysis and CVD Risk Assessment

Sponsor

HJN Sverige AB/Neko Health

Enrollment

1,600 participants

Start Date

Jul 1, 2024

Study Type

OBSERVATIONAL

Conditions

Heart Failure Arterial Stiffness Aortic Valve Disease Coronary Arterial Disease (CAD)

Summary

This clinical investigation will evaluate a novel contactless technology for assessing arterial stiffness and pulse wave characteristics and explore its potential in assessment of coronary artery disease, aortic stenosis and heart failure, in a population-based sample aged 58-72 years. It will be the first in clinical setting, pilot stage, observational investigation to evaluate the clinical safety, performance and diagnostic accuracy of Cardio P4, a laser-doppler vibrometry (LDV) and microwave radar-based device.

Eligibility

Min Age: 58 YearsMax Age: 72 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a wearable device that uses vibration sensing (a vibrometer) to measure pulse wave patterns — the way your heartbeat travels through your blood vessels — as a non-invasive way to assess heart and blood vessel health. It is part of a large population-based cardiovascular health study in Sweden (SCAPIS 2). **You may be eligible if...** - You are already enrolled in the main SCAPIS 2 study at Danderyd Hospital in Stockholm - You have completed the echocardiography (heart ultrasound) exam as part of that study **You may NOT be eligible if...** - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTCoronary Computer Tomography (CCTA)

Use of standard equipment for usual care

OTHERLaser Doppler Vibrometry and single-lead ECG

Physiological data acquisition equipment

DEVICEEchocardiography

GE Vivid E95

DEVICEPulse Wave Velocity

Arteriograph, Tensiomed, Hungary

Locations(1)

Danderyds Hospital, KFC - Hjärt-kärllaboratoriet

Stockholm, Sweden

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NCT07001007

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