SCAPIS 2 Cardio - Vibrometer Based Pulse Wave Analysis and CVD Risk Assessment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,600
- Locations
- 1
- Primary Endpoint
- Area under receiver operating curve (ROC) to predict CAD-RADS ≥2
Study Overview
Brief 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.
Detailed Description
Cardiovascular disease (CVD) is the leading cause of death globally, placing a large burden on the healthcare system.
In asymptomatic individuals, there exists several risk scores to predict cardiovascular events (like SCORE2, SCORE2-OP and Framinham Risk Score). In patients with suspected symptoms of coronary artery disease, the European Society of Cardiology advice to estimate the pre-test probability by the risk factor-weighted clinical likelihood (RF-CL).
Most of these scores include the key factors for CAD development including age, sex, LDL- (or non-HDL) cholesterol, diabetes, smoking history, blood pressure or hypertension. Coronary computed tomography angiography (CCTA) is one of the main recommended examinations at low-intermediary risk based on PTP. While the procedure is non-invasive and relatively safe in comparison to invasive alternatives, they still represent a risk to the patient by radiation exposure and incidental findings, and is associated with lack of availability.
One key issue is that once a patient has a CCTA performed showing coronary atherosclerosis, that entails optimized prevention, with solid evidence. However, patients without symptoms of CAD are less studied regarding the degree of CAD. The present SCAPIS trial is the largest such trial on CCTA in 30 000 patients age 50 to 64 years, 25 182 individuals without known coronary heart disease were included. In these asymptomatic persons, CCTA-detected atherosclerosis was found in 42.1% and a significant stenosis (≥50%) in 5.2%.
Arterial stiffness, commonly assessed as pulse wave velocity (PWV), is a marker of aging of the cardiovascular system, and is independently associated with coronary artery disease. Increased arterial stiffness is an early indicator of cardiovascular disease and may improve precision in risk stratification. Laser-Doppler and microwave radar are new promising methods for analysis of pulse waves in human blood vessels. The technology may be more suitable for screening through enabling lower operator dependence and faster assessment time in comparison to standard assessment methods, and may contribute to lower overall healthcare costs and improved precision in identification of CVD.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 58 Years to 72 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Area under receiver operating curve (ROC) to predict CAD-RADS ≥2
Time Frame: Typically within 2 months of enrolment
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.
Secondary Outcomes
- Correlation between vibrometer-based PWA from the suprasternal notch and PWV by Arteriograph(Typically within 2 months of enrolment)
- Area under receiver operating curve (ROC) to predict CAD-RADS ≥3(Typically within 2 months of enrolment)
- Area under receiver operating curve (ROC) to predict CAD-RADS ≥2(Typically within 2 months of enrolment)
- Area under receiver operating curve (ROC) to predict CAD-RADS ≥2 stratified by sex(Typically within 2 months of enrolment)
- Area under receiver operating curve (ROC) to predict CAD-RADS ≥2 stratified by body mass index strata(Typically within 2 months of enrolment)
- Correlation between vibrometer-based PWA from the suprasternal notch and CAD-RADS score(Typically within 2 months of enrolment)
- Correlation between pressure sensor (piezo) based PWV and CAD-RADS score(Typically within 2 months of enrolment)
- Correlation between vibrometer-based PWV and CAC score(Typically within 2 months of enrolment)
- Machine learning analysis of Vibrometer signals(Same day as enrolment)
- Correlation between vibrometer-based PWV and left ventricular mass index(Same day as enrolment)
- Correlation between vibrometer-based left ventricular ejection time and left ventricular ejection fraction(Same day as enrolment)
- Correlation between vibrometer-based PEP/LVET ratio and LVEF(Same day as enrolment)
- Correlation between vibrometer-based LVET and degree of aortic stenosis(Same day as enrolment)
- Correlation between vibrometer-based PEP/LVET ratio and degree of aortic stenosis(Same day as enrolment)
- Correlation between vibrometer-based LVET and degree of aortic valve calcification(Same day as enrolment)
- Correlation between vibrometer-based PEP/LVET and degree of aortic valve calcification(Same day as enrolment)
- Correlation between vibrometer-based LVET and markers of diastolic dysfunction(Same day as enrolment)
- Correlation between vibrometer-based PEP/LVET markers of diastolic dysfunction(Same day as enrolment)