Stress-induced immune reprogramming in cardiovascular disease (STRESS-CVD)

Stress-induced immune reprogramming in cardiovascular disease (STRESS-CVD) - STRESS-CVD

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53178

Enrollment

Registered

2023-09-19

Start date

2024-11-21

Completion date

Unknown

Last updated

2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerosis, cardiovascular disease, stress

Interventions

none

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all  of the following criteria: - Age 40-70 years - Heightened cardiovascular risk, defined as a) a moderate to high risk for CVD  (>5% 10 year ASCVD risk, according to American College of Cardiology (ACC)  AtheroSclerotic Cardiovascular Disease (ASCVD) risk calculator  (https://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/) or b)  subclinical ASCVD on imaging (e.g. elevated CAC or asymptomatic  coronary artery stenosis), or c) a LDL-c concentration > 4.9 mmol/l. - Written informed consent

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded  from participation in this study: • Previous cardiovascular events (stroke, TIA, myocardial infarction, coronary revascularization, aortic aneurysm, peripheral arterial disease) • Heart failure • Auto-inflammatory or auto-immune diseases • Use of immunomodulating drugs • Severe renal failure (MDRD <30) • Previous vaccination within 1 months prior to study entry. • Current infection or clinically significant infections within 1 months before  participation (defined as fever >38.5). • Pregnancy/lactation  • Severe psychiatric disorder. • Inability to undergo PET-CT scanning • History of hematological malignant disease • Documented bleeding diathesis or thrombocytopenia <50 *10e9/L

Design outcomes

Primary

Measure	Time frame
All 85 included patients will fill out questionnaires and donate blood. The primary outcome is the correlation between the ex vivo production of TNF by isolated Peripheral Blood Mononuclear Cells (PBMCs) and perceived stress (measured with the PSS-10 questionnaire).	—

Secondary

Measure	Time frame
Additional study parameters are flow cytometry, and (single cell) RNA and ATAC sequencing of circulating immune cells and circulating HSPCs.	—

Countries

Netherlands

Contacts

Public ContactN. P. Riksen

Radboud Universitair Medisch Centrum

niels.riksen@radboudumc.nl0243618819

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)