NL-OMON38643已完成2 期
Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a pilot study - NoSIRS
Medtronic Inc., Cardiac Rhythm Disease Management0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Written informed consent to participate in this trial;2. Male subjects aged 18 to 35 years inclusive;3. Healthy as determined by medical history, physical examination, vital signs, 12 lead electrocardiogram, and clinical laboratory parameters
排除标准
- •Use of any medication(including herbal remedies and vitamin/mineral supplements) or recreational drugs within 7 days prior to profiling day;• Smoking;• Use of caffeine, or alcohol or within 1 day prior to profiling day ;• Previous participation in a trial where LPS was administered;• Surgery or trauma with significant blood loss or blood donation within 3 months prior to profiling day;• Participation in another clinical trial within 3 months prior to profiling day.;• History, signs or symptoms of cardiovascular disease;• An implant that in the opinion of the investigator may make invasive proceedures risky for the subject due to the increased risks associated with a possible infection.;• Subject has an implanted active cardiac device (ICD, IPG and/or CRT);• Implanted active neurostimulation device;• Subject has internal jugular vein that cannot be accessed;• History of vaso-vagal collapse or of orthostatic hypotension;• History of atrial or ventricular arrhythmia;• Resting pulse rate <=45 or >=100 beats / min;• Hypertension (RR systolic >160 or RR diastolic >90);• Hypotension (RR systolic <100 or RR diastolic <50);• Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complex bundle branch block;• Subject is diagnosed with epilepsy or history of seizures;• Renal impairment: plasma creatinine >120 µmol/L;• Liver function abnormality: alkaline phosphatase >230 U/L and/or ALT >90 U/L;• Coagulation abnormalities: APTT or PT >1.5 times the reference range;• History of asthma;• Immuno-deficiency;• CRP >20 mg/L, WBC >12x109/L, or clinically significant acute illness, including infections, within 2 weeks before profiling day;• Known or suspected of not being able to comply with the trial protocol;• Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study.
研究者
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