EUCTR2012-005687-97-NL进行中（未招募）不适用
Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a pilot study - Transvenous VNS Immune Response
Medtronic Inc.0 个研究点开始时间: 2013年2月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
- •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, in particular
- •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 frequent 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.
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