NCT02265016已完成不适用
Regulation and Signaling of RBC-eNOS in Patients With Stable and Unstable Coronary Artery Disease
Heinrich-Heine University, Duesseldorf1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Determination of red cell endothelial nitric oxide-synthase (eNOS)-expression and - activity
研究概览
简要总结
The aim of this study is measurement of expression and activity of RBC eNOS in different clinical cohorts of patients with coronary artery disease and acute coronary syndrome and to investigate the importance of the NO-stimulated reaction cascade in terms of sGC and PKG.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consent
- •for ACS(acute coronary syndrome)-Group: angiographic coronary artery disease; acute coronary syndrome, defined by EITHER unstable angina pectoris with significant coronary stenosis (troponin negative, without significant ST-elevation) OR low-risk NSTEMI (Troponin positive, without significant ST-elevation)
- •for stable CAD-Group: angiographic coronary artery disease; no acute coronary syndrome within the last 3 months
- •healthy control group: No clinical or angiographical signs of apparent atherosclerosis
排除标准
- •acute inflammation (CRP > 1 mg/dl, leukocyte > 11.000/µl)
- •malignant diseases
- •pregnancy
- •medication with NO-donors ( e.g.isosorbide mononitrate, isosorbide dinitrate, glyceryl trinitrate, Molsidomin, Ranexa)
- •patients with STEMI or high-risk NSTEMI
结局指标
主要结局
Determination of red cell endothelial nitric oxide-synthase (eNOS)-expression and - activity
时间窗: baseline, 3 hours and 3 month
次要结局
- Determination of arterial stiffness(baseline, 3 hours and 3 month)
- Microvascular function(baseline, 3 hours and 3 month)
- Determination of nitric oxide and cyclic guanosine monophosphate (cGMP) in blood plasma and in red blood cells(baseline, 3 hours and 3 month)
- Electrocardiogram(baseline, 3 hours and 3 month)
- Deformability and stability of red blood cell membrane(baseline, 3 hours and 3 month)
- determination of flow-mediated dilation(baseline, 3 hours and 3 month)
- Determination of nitrate and nitrite in blood plasma and red blood cells (RBC)(baseline, 3 hours and 3 month)
- Aggregation of red blood cells(baseline, 3 hours and 3 month)
- Peripheral and central hemodynamic measurement(baseline, 3 hours and 3 month)
- Determination of endothelial microparticles(baseline, 3 hours and 3 month)
- Aging and turnover of red blood cells(baseline, 3 hours and 3 month)
- Platelet aggregometry(baseline, 3 hours and 3 month)
- Redox status of red blood cells(baseline, 3 hours and 3 month)
- Changes of tetrahydrobiopterin-metabolism(baseline, 3 hours and 3 month)
- Expression and function of soluble guanylyl cyclase (sGC) in red blood cells(baseline, 3 hours and 3 month)
- Expression and activity of Protein Kinase G (PKG)(baseline, 3 hours and 3 month)
- Determination of leucocyte populations and leucocyte function(baseline, 3 hours and 3 month)
研究者
Klinik für Kardiologie, Pneumologie und Angiologie
Principle Investigator Prof. Dr. Malte Kelm
Heinrich-Heine University, Duesseldorf
研究点 (1)
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