SCAPIS 2 Cardio - Vibrometer Based Pulse Wave Analysis and CVD Risk Assessment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age58-72
SponsorHJN Sverige AB/Neko Health
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Patients unable to provide an informed consent
Trial design
Treatments tested in this trial
- Coronary Computer Tomography (CCTA)
- Laser Doppler Vibrometry and single-lead ECG
- Echocardiography
- Pulse Wave Velocity
Treatment groups
1,600 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov