cardiac arrest
Conditions
Interventions
None listed
Sponsors
CHDR
Eligibility
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 ½ 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study parameters/outcome of the study: 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 lmmunoglobulin classes: - total lgG, lgM, lgE. oxLDL lgG1, lgG2 + lgM. - oxLDL specific lgM and lgG ELlSpot B cell functionality, by means of ex vivo challenges, evaluating: - Pathways: . TLR7 stimulation . TLR9 stimulation - Readouts: [] Circulating cytokines (e.g. lL-10 and lL-35 + lL-12p70,lL-1ß, TNFa, lL-6, lL-17) [] Secreted cytokines after stimulation (e.g. lL-10, lL-35, TGFß, pro-inflammatory cytokines) [] lntracellular cytokines (e.g. lL-10, lL-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 - lmmune cells in adipose tissue | — |
Contacts
Public ContactMatthijs Moerland
Centre for Human Drug Research
Outcome results
None listed