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
This trial accepts healthy volunteersQualifiers
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 population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Coronary Computer Tomography (CCTA)
Diagnostic testUse of standard equipment for usual care
Laser Doppler Vibrometry and single-lead ECG
Other interventionPhysiological data acquisition equipment
Echocardiography
DeviceGE Vivid E95
Pulse Wave Velocity
DeviceArteriograph, Tensiomed, Hungary
Treatment groups
1,600 Participants
are divided into 1 treatment groupGroup A: SCAPIS2_cohort4 interventions
Trial outcomes
Primary outcomes
1
Area under receiver operating curve (ROC) to predict CAD-RADS ≥2
Change in area under receiver operating curve (ROC) to predict CAD-RADS ≥2 when adding Vibrometer-based SSN femoral PWV to the standard risk factors. Coronary artery disease reporting and data system (CAD-RADS) ≥2 refers to the classification of coronary artery disease with at least moderate stenosis as identified on coronary computer tomography angiography. The classification follows the CAD-RADS 2.0 definition. Stenosis is graded in severity from 0-5.
Time frame
Typically within 2 months of enrolmentSecondary outcomes
1
Area under receiver operating curve (ROC) to predict CAD-RADS ≥3
Change in area under receiver operating curve (ROC) to predict CAD-RADS ≥3 when adding Vibrometer-based SSN femoral PWV to the standard risk factors.
Time frame
Typically within 2 months of enrolment2
Area under receiver operating curve (ROC) to predict CAD-RADS ≥2
Change in area under receiver operating curve (ROC) to predict CAD-RADS ≥2 when adding Vibrometer-based amplitude-ratio from the early phase of the waveform to the standard risk factors.
Time frame
Typically within 2 months of enrolment3
Area under receiver operating curve (ROC) to predict CAD-RADS ≥2 stratified by sex
Prespecified subgroup analysis stratified by sex. Change in area under receiver operating curve (ROC) to predict CAD-RADS ≥2 when adding Vibrometer-based SSN femoral PWV to the standard risk factors.
Time frame
Typically within 2 months of enrolment4
Area under receiver operating curve (ROC) to predict CAD-RADS ≥2 stratified by body mass index strata
Prespecified subgroup analysis stratified by body mass index strata. Change in area under receiver operating curve (ROC) to predict CAD-RADS ≥2 when adding Vibrometer-based SSN femoral PWV to the standard risk factors.
Time frame
Typically within 2 months of enrolmentSponsors and contacts
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Source ClinicalTrials.gov