NL-OMON38648撤回不适用
Monocyte behaviour in human upon sympathetic stimulus via LBNP with and without beta-blocker therapy. - LBNP
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Healthy controls
- •* Adults (either gender) * 18 years
- •* Willing and able to participate in study protocol;Splenectomized patients
- •* Adults (either gender) * 18 years
- •* History of traumatic splenectomy
- •* Participated in scientific research at the AMC previously and have given permission via informed consent to be willing to be contacted for other research at the AMC in the future.
- •* Willing and able to participate in study protocol;Cardiovascular patients
- •* Adults (either gender) * 18 years
- •* Cardiovascular patients are recognized by atherosclerotic cardiovascular disease, thus atherosclerosis in either coronary, carotid, aortic and/or peripheral arteries. The above needs to be documented in the history of the patient by one or more of the following:
- •o History of coronary heart disease (angina pectoris, myocardial infarction), cerebrovascular disease (stroke), peripheral arterial disease (claudicatio intermittens).
- •o Objective diagnostic (imaging) examinations, including exercise treadmill test, stress echocardiography, myocardial perfusion scintigraphy, right or left common carotid intima-media thickness (CIMT) by ultrasound > 75th percentile by American Society of Echocardiography, presence of carotid plaque by carotid ultrasound (focal thickening > 50% or CIMT > 1.5 mm), coronary artery calcium score > 100 Agatston units in patients < 60 years of age, CT or conventional coronary or peripheral angiography with at least one moderate or severe luminal stenosis, CT coronary angiography with one or more atherosclerotic plaques demonstrating positive remodeling or hypodense plaque morphology, moderate or severe aortic atherosclerosis by CT or Transesophageal echocardiography,
- •o History of revascularization procedure (e.g., coronary or peripheral arterial bypass grafting, percutaneous coronary or peripheral intervention, carotid endarterectomy).
- •* Willing and able to participate in study protocol
- •* For patients using statins, angiotensin-converting enzyme (ACE) inhibitors (ACE-I) or angiotensin-receptor blockers (ARBs), non-statin lipid-modifying therapy, thiazolidinediones, inhaled steroids, or leukotriene modifying agents; use of a stable dose for at least 6 weeks prior to the first visit.
排除标准
- •Healthy controls are not eligible if they meet one of the criteria listed below:
- •* Any known systemic chronic disorders/medical condition or chronic use of systemic medication that could interfere with the conduct of the study in the opinion of the investigator.
- •* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.;Splenectomized patients are not eligible if they meet one of the criteria listed below:
- •* History of cardiovascular diseases (including atherosclerotic CVD, heartfailure, etc) or cardiovascular medication such as use of beta blocker therapy, calciumantagonists and CYP2D6 inhibitors.
- •* Auto-immune disease/vasculitis, other active inflammatory diseases, proven or suspected bacterial infections. Recent (<1 month prior to screening) or ongoing serious infection requiring IV antibiotic therapy that could interfere with the conduct of the study in the opinion of the investigator.
- •* Known systemic disorders such as asthma, hepatic, renal, hematologic, and malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
- •* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.;Cardiovascular patients are not eligible if they meet one of the criteria listed below:
- •* Other cardiovasular disease than the previously defined atherosclerotic cardiovascular disease patients, including heart failure, cardiomyopathy, aneurysms, hypertensive heart disease, cor pulmonale, cardiac dysrhythmias including sick-sinussyndrome, 2nd- en 3rd degree AV-block, inflammatory heart disease such as endocarditis, myocarditis and rheumatic heart disease, valvular heart disease and congenital heart disease.
- •* Use of beta blocker therapy, calciumantagonists and CYP2D6 inhibitors (for example paroxetin, fluoxetin) within 3 months prior to screening visit are not allowed based on their effect on bloodpressure regulation.
- •* Auto-immune disease/vasculitis, other active inflammatory diseases, proven or suspected bacterial infections. Recent (<1 month prior to screening) or ongoing serious infection requiring IV antibiotic therapy that could interfere with the conduct of the study in the opinion of the investigator.
- •* Known systemic disorders such as asthma, hepatic, renal, hematologic, and malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
- •* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
研究者
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