SCAPIS 2 Cardio - Vibrometer Based Pulse Wave Analysis and CVD Risk Assessment
Recruiting · NCT07001007 · Observational (researchers observe without assigning treatment) · Lead sponsor: HJN Sverige AB/Neko Health
View the official record on ClinicalTrials.gov →Interventions studied
Coronary Computer Tomography (CCTA)EchocardiographyLaser Doppler Vibrometry and single-lead ECGPulse Wave Velocity
What this trial is about
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.
Who can take part
Age range
58 Years to 72 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- Patients unable to provide an informed consent
Where it is running
1 location listed.
- Danderyds Hospital, KFC - Hjärt-kärllaboratoriet - Stockholm, Sweden