NCT07359768 Non-invasive Microvascular Assessment in Individuals at High Risk of Cardiovascular Disease From the SCAPIS2 Study
| NCT ID | NCT07359768 |
| Status | Recruiting |
| Phase | — |
| Sponsor | HJN Sverige AB/Neko Health |
| Condition | Cardiovascular Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 900 participants |
| Start Date | 2024-03-18 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 900 participants in total. It began in 2024-03-18 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Participated in the SCAPIS baseline (SCAPIS 1 study, 10 years ago) * Cohort specific inclusion criteria apply, as stated in 'groups' section * Has been invited to SCAPIS 2 core Singed informed consent to SCAPIS 2 core Exclusion Criteria: * Scarring, tattoos, or amputations that preclude device examination * Cohort specific exclusion criteria apply, as stated in 'groups' section
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07359768 clinical trial?
This trial is open to participants of all sexes, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07359768 currently recruiting?
Yes, NCT07359768 is actively recruiting participants. Contact the research team at mattias@nekohealth.com for enrollment information.
Where is the NCT07359768 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT07359768 clinical trial?
NCT07359768 is sponsored by HJN Sverige AB/Neko Health. The trial plans to enroll 900 participants.