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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Danderyd Hospital
RECRUITING
Stockholm
Contact Information
Primary
Mattias Windå, Chief Science and Innovation Officer
mattias@nekohealth.com
+46703169040
Time Frame
Start Date: 2024-03-18
Estimated Completion Date: 2026-12-29
Participants
Target number of participants: 900
Treatments
O-CAD
O-CAD arm inclusion is based on burden of coronary atherosclerosis measure in computer tomography of coronary arteries (CCTA) as measured by coronary artery disease reporting and data system (CADRADS). If CAD-RADS is above or equal to 3, participant may be eligible for inclusion in O-CAD arm.
ANOCA
ANOCA arm inclusion is dictated by presence of cardiac angina as defined by the rose questionnaire and CAD-RADS \<3. Exclusion criteria are similar as to those for stress-CMR.
Metabolic
Inclusion is dictated by prevalence of diabetes mellitus concomitantly present with metabolic syndrome with metabolic syndrome severity score higher than 4. Exclusion criteria are similar as to those for stress-CMR, alongside CAD RADS \< 3 and no angina as defined by rose questionnaire.
Left ventricular diastolic dysfunction
Inclusion is dictated by diastolic dysfunction as defined by British Society of Echocardiography. Exclusion criteria are similar as to those for stress- CMR, alongside CAD RADS \< 3 and no angina as defined by rose questionnaire.
Sponsors
Leads: HJN Sverige AB/Neko Health

This content was sourced from clinicaltrials.gov