cardiac arrest
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy volunteers: 1. healthy male subjects (18-25 years or >60 years); 2. ability to participate, and willingness to give written informed consent and to comply with the study restrictions. 3. BMI 18 - 28 4. non-smoking, elderly non-smoking for at least 15 years. smokers: 1. male subjects (18-25 years or >45 years) 2. ability to participate, and willingness to give written informed consent and to comply with the study restrictions. 3. BMI 18 - 28 4. volunteers >45 years: smoking for at least 15 packyears, volunteers 18- 25 years: at least * pack a day for 6 months. , CAD patients: 1. male patients (>60 years) with proven stable atherosclerotic coronary artery disease defined as having undergone a revascularization procedure followed by a period of at least one year without signs or symptoms of coronary artery disease; 2. having one of the following risk factors: high cholesterol, smoking, diabetes, hypertension, or familiar risk. 3. ability to participate, and willingness to give written informed consent and to comply with the study restrictions. 4. BMI 18 - 28
Exclusion criteria
Exclusion criteria: healthy volunteers: 1. evidence of any active or chronic disease or condition (based on medical history, a physical examination, and vital signs) that could, in the opinion of the investigator, interfere with the study objectives; 2. evidence of any active or chronic disease or condition that affects the immune system. 3. having one of the following risk factors for CAD: high cholesterol, smoking, diabetes, hypertension, or familiar risk. 4. the use of any medication or vitamin/mineral/herbal/dietary supplement within less than 5 half-lives prior to study participation is prohibited, if the Investigator judges that it may interfere with the study objectives. The use of paracetamol (up to 4 g/day) is allowed; 5. body weight 28. 6. subject is pregnant or breast feeding; 7. smoking or current substance abuse, including alcohol and drugs; 8. loss or donation of blood over 500 mL within three months prior to participation; 9. unwillingness or inability to comply with the study protocol for any other reason., Smokers: 1. evidence of any active or chronic disease or condition (based on medical history, a physical examination, and vital signs) that could, in the opinion of the investigator, interfere with the study objectives; 2. body weight 35; 3. substance abuse, including alcohol and drugs; 4. loss or donation of blood over 500 mL within three months prior to participation; 5. unwillingness or inability to comply with the study protocol for any other reason., CAD patients: 1. evidence of any active or chronic disease or condition other than stable CAD (based on medical history, a physical examination, and vital signs) that could, in the opinion of the investigator, interfere with the study objectives; 2. evidence of any active or chronic disease or condition other than stable CAD that affects the immune system. 3. body weight 28. 4. substance abuse, including alcohol and drugs; 5. loss or donation of blood over 500 mL within three months (males) prior to participation; 6. unwillingness or inability to comply with the study protocol for any other reason. 7. use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Circulating B cell subsets: - B1 cells - Naive B cells - Transitional B cells - Non-class-switched memory B cells - Class-switched memory B cells - Plasmablasts and plasma cells - Regulatory B-cells - Age associated B-cells Immunoglobulin classes: - total IgG, IgM, IgE. oxLDL IgG1, IgG2 + IgM. - oxLDL specific IgM and IgG ELISpot B cell functionality, by means of ex vivo challenges, evaluating: - Pathways: * TLR7 stimulation * TLR9 stimulation - Readouts: * Cellular mRNA (isolated B-cells) * Circulating cytokines (e.g. IL-10 and IL-35 + IL-12p70, IL-1*, TNF*, IL-6, IL-17) * Secreted cytokines after stimulation (e.g. IL-10, IL-35, TGF*, pro-inflammatory cytokines) * Intracellular cytokines (e.g. IL-10, IL-35) * Surface markers on B-cells (non-lineage markers) (e.g. PD-1, PDL-1, PDL-2, TIM-1) - Other relevant immune cells including, but not limited to: o CD4+ T cells (Th1/Th2/Th17/Treg), CD8+ T cells, inflammatory monocytes, neutrophils, basophils - Routine laboratory blood tests: o Chemistry o Hematology - Immune cells in adipose tissue | — |
Secondary
| Measure | Time frame |
|---|---|
| N.A. | — |
Countries
Netherlands
Outcome results
None listed