NL-OMON53178Not yet recruitingNot Applicable
Stress-induced immune reprogramming in cardiovascular disease (STRESS-CVD) - STRESS-CVD
niversitair Medisch Centrum0 sites125 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 125
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
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 moderate to high risk for CVD
- •(>7.5% 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
- •patients with subclinical ASCVD on imaging (e.g. elevated CAC or asymptomatic
- •coronary artery stenosis).
- •- Written informed consent
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)
- •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
Investigators
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