B cell monitoring in healthy donors, smokers and CAD patients

Recruiting

Conditions: cardiac arrest

Registration Number: NL-OMON26137

Lead Sponsor: CHDR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 150

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

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 < 50 kg; BMI <18 or >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 < 50 kg; or BMI <18 or >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 < 50 kg; BMI <18 or >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.