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SCAPIS 2 Cardio - Vibrometer Based Pulse Wave Analysis and CVD Risk Assessment
Sponsor: HJN Sverige AB/Neko Health
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.
Key Details
Gender
All
Age Range
58 Years - 72 Years
Study Type
OBSERVATIONAL
Enrollment
1600
Start Date
2024-07-01
Completion Date
2026-06
Last Updated
2025-06-03
Healthy Volunteers
Yes
Interventions
Coronary Computer Tomography (CCTA)
Use of standard equipment for usual care
Laser Doppler Vibrometry and single-lead ECG
Physiological data acquisition equipment
Echocardiography
GE Vivid E95
Pulse Wave Velocity
Arteriograph, Tensiomed, Hungary
Locations (1)
Danderyds Hospital, KFC - Hjärt-kärllaboratoriet
Stockholm, Sweden