NL-OMON26137招募中不适用
B cell monitoring in young and elderly healthy donors, young smokers, elderly smokers and patients with stable coronary artery disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CHDR
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •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.
- •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
排除标准
- •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.
- •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.
研究者
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