SCAPIS 2 Cardio - Vibrometer Based Pulse Wave Analysis and CVD Risk Assessment

NCT07001007 | Recruiting

• 1 other identifier: CRD-P4-LMV_CIP-240116
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Arterial Disease (CAD); Arterial Stiffness; Aortic Valve Disease; Heart Failure

Outcome Measures

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.

  Typically within 2 months of enrolment

Secondary Outcomes (20)

• 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 PWV by Arteriograph

  Typically within 2 months of enrolment

Study Arms (1)

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.

Diagnostic Test: Coronary Computer Tomography (CCTA); Other: Laser Doppler Vibrometry and single-lead ECG; Device: Echocardiography; Device: Pulse Wave Velocity

Interventions

Coronary Computer Tomography (CCTA) DIAGNOSTIC_TEST

Use of standard equipment for usual care

SCAPIS2_cohort

Laser Doppler Vibrometry and single-lead ECG OTHER

Physiological data acquisition equipment

SCAPIS2_cohort

Echocardiography DEVICE

GE Vivid E95

SCAPIS2_cohort

Pulse Wave Velocity DEVICE

Arteriograph, Tensiomed, Hungary

SCAPIS2_cohort

Eligibility Criteria

• Age: 58 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Patients unable to provide an informed consent

Sponsors & Collaborators

• HJN Sverige AB/Neko Health: lead

Study Sites (1)

Danderyds Hospital, KFC - Hjärt-kärllaboratoriet

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease; Heart Failure

Interventions

Echocardiography; Pulse Wave Analysis

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Professor Jonas Spaak, MD, PhD

  Karolinska Institute, Department of Clinical Sciences, Danderyd Hospital, Division of Cardiovascular Medicine, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mattias Windå

CONTACT

+46703169040; mattias@nekohealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 3, 2025
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

SE (1)