RecruitingNCT07359768

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

SCAPIS 2 - Spectrum Study -CVD Risk Based on Microvascular Dysfunction


Sponsor

HJN Sverige AB/Neko Health

Enrollment

900 participants

Start Date

Mar 18, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This observational sub-study of the Swedish Cardiopulmonary Bioimage Study (SCAPIS-2) examines how well tiny blood vessels (microvascular function) work in people aged 60–75 who have specific heart or metabolic conditions, such as coronary artery disease, angina with normal-looking arteries, metabolic syndrome with diabetes, or heart muscle dysfunction. Researchers will use non-invasive skin sensors and stress cardiac MRI to map and measure blood flow in the skin and heart, looking for early warning signs of disease. Adults who previously participated in the original SCAPIS study (about 10 years ago) and have been invited to SCAPIS-2 may be eligible, with additional cohort-specific criteria depending on which condition they have. Participation involves applying specialized devices to the skin, undergoing stress MRI with adenosine infusion and contrast dye, and attending one study visit. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Danderyd Hospital

Stockholm, Danderyd, Sweden

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NCT07359768


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