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

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

Inclusion Criteria1

  • 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 Criteria1

  • Patients unable to provide an informed consent

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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