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临床试验/NCT03037775
NCT03037775Unknown不适用

The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters and Sympathetic Nerves Activity in Healthy People

Medical University of Warsaw2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
Heart rate variability

研究概览

简要总结

It is intended to examine 50 healthy volunteers aged 18 - 60 years. 12-hour abstinence from tobacco smoke, alcohol or coffee before the experiment will be required. The exclusion criteria are medical history of stroke, coronary artery disease, chronic heart failure, hypertension, peripheral vascular disease, atrial fibrillation, polyneuropathy, obesity (BMI> 30 kg/m2), the current active disease (eg. viral infection). Test subjects will actively inhale for 10 minutes tobacco or the e-cigarette smoke with nicotine fluid (18 mg/ml) or fluid without nicotine for 10 minutes. The study protocol involves random allocation to groups exposed to electronic or traditional cigarette smoke in cross-over scheme. The primary endpoint is the maximum change in heart rate compared to mean values prior to exposure. Secondary end points is the maximum change in the measured parameters (hemodynamic and autonomic values) compared to the average values before exposure. The measurements will be performed using the Task Force Monitor system for non-invasive measurement of hemodynamic parameters and the assessment of autonomic function. Adrenergic activity will be tested with microneurography. A periodic analysis is planned after examining 15 and 35 patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy volunteers aged 18 - 60 years
  • 12-hour abstinence from tobacco smoke, alcohol or coffee before the experiment will be required

排除标准

  • history of stroke, coronary artery disease, chronic heart failure, hypertension, peripheral vascular disease, atrial fibrillation, polyneuropathy, obesity (BMI> 30 kg/m2), the current active disease (eg. viral infection).

结局指标

主要结局

Heart rate variability

时间窗: through study completion, an average of 1 year

RR intervals in ms, very low frequency (VLF), low frequency (LF), and high frequency (HF) components - ms2

次要结局

  • Heart rate(through study completion, an average of 1 year)
  • Blood pressure variability(through study completion, an average of 1 year)
  • Systolic, diastolic, mean blood pressure(through study completion, an average of 1 year)
  • Puls wave velocity(through study completion, an average of 1 year)
  • Stroke Volume(through study completion, an average of 1 year)
  • Cardiac output(through study completion, an average of 1 year)
  • Total Peripheral Resistance(through study completion, an average of 1 year)
  • Baroreceptor reflex sensitivity(through study completion, an average of 1 year)
  • Muscle sympathetic nerve activity(through study completion, an average of 1 year)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacek Lewandowski

M.D., Ph.D.

Medical University of Warsaw

研究点 (2)

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