Actively Recruiting

All Genders
NCT07359768

Non-invasive Microvascular Assessment in Individuals at High Risk of Cardiovascular Disease From the SCAPIS2 Study

Led by HJN Sverige AB/Neko Health · Updated on 2026-01-22

900

Participants Needed

1

Research Sites

145 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Microvascular dysfunction, particularly endothelial dysfunction, is increasingly recognized as a key mechanism underlying various cardiovascular diseases (CVD), including heart failure, ischemic heart disease, atherosclerosis, stroke, dementia, and kidney failure. Chronic low-grade inflammation linked to metabolic syndrome may further drive systemic microvascular impairment. Early detection of these subclinical processes using non-invasive assessments could facilitate timely interventions to prevent disease progression. SCAPIS 2 Spectrum is a prospective observational sub-study of the Swedish Cardiopulmonary Bioimage Study (SCAPIS-2), recruiting approximately 900 subjects aged 60-75 years. The study is organized into five arms-obstructive coronary artery disease (O-CAD), angina with nonobstructive coronary arteries (ANOCA), metabolic syndrome with diabetes, left ventricular systolic dysfunction, and left ventricular diastolic dysfunction-each defined by specific inclusion and exclusion criteria. Participants will undergo a comprehensive microvascular assessment using investigational devices (including Perimed Periflux EPOS, PeriCam MultiFlow, and TCI P4) alongside stress cardiac magnetic resonance imaging (stress-CMR) for cardiac-specific evaluation.

CONDITIONS

Official Title

Non-invasive Microvascular Assessment in Individuals at High Risk of Cardiovascular Disease From the SCAPIS2 Study

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participated in the SCAPIS baseline study approximately 10 years ago
  • Meets group-specific inclusion criteria as defined in the study
  • Has been invited to SCAPIS 2 core and provided signed informed consent
Not Eligible

You will not qualify if you...

  • Scarring, tattoos, or amputations that prevent device examination
  • Meets group-specific exclusion criteria as defined in the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Danderyd Hospital

Stockholm, Danderyd, Sweden

Actively Recruiting

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Research Team

M

Mattias Windå, Chief Science and Innovation Officer

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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