SCAPIS 2 Cardio - Vibrometer Based Pulse Wave Analysis and CVD Risk Assessment
Status: Recruiting
Location: See location...
Intervention Type: Other, Device, Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 58
Maximum Age: 72
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
Sweden
Danderyds Hospital, KFC - Hjärt-kärllaboratoriet
RECRUITING
Stockholm
Contact Information
Primary
Mattias Windå
mattias@nekohealth.com
+46703169040
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 1600
Treatments
SCAPIS2_cohort
In SCAPIS (2014 -2018) 30.000 randomly selected adults between the ages of 50 - 64 were included. SCAPIS 2 is the re-assessment study of half of the original study cohort. In Stockholm (Danderyd Hospital site) that corresponds to 2500 adults (that are now between 6-10 years older than the first SCAPIS study). The present study described in this CIP is a prospective, observational substudy of SCAPIS 2, done in collaboration with Karolinska Institutet (KIDS) and Danderyd Hospital.
Related Therapeutic Areas
Sponsors
Leads: HJN Sverige AB/Neko Health