MedTrace Logo

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

NCT07001007 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1600

Last updated 2025-06-03

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Coronary Computer Tomography (CCTA)

Use of standard equipment for usual care

OTHER

Laser Doppler Vibrometry and single-lead ECG

Physiological data acquisition equipment

DEVICE

Echocardiography

GE Vivid E95

DEVICE

Pulse Wave Velocity

Arteriograph, Tensiomed, Hungary

Sponsors & Collaborators

  • HJN Sverige AB/Neko Health

    lead INDUSTRY

Principal Investigators

  • Professor Jonas Spaak, MD, PhD · Karolinska Institute, Department of Clinical Sciences, Danderyd Hospital, Division of Cardiovascular Medicine, Stockholm, Sweden

Eligibility

Min Age
58 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07001007 on ClinicalTrials.gov