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临床试验/NCT02310373
NCT02310373终止1 期

Effects of Nicotine-Free Hookah Smoking on Blood Flow to the Heart, Muscle and Skin

Cedars-Sinai Medical Center2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
1 期
状态
终止
入组人数
9
试验地点
2
主要终点
Change in sympathetic nerve activity

研究概览

简要总结

This is a pilot study on the acute effects of nicotine-free hookah (herbal/steam stones) smoking on the sympathetic neural control of the human cardiovascular system. Hookah smoking is known to transiently increase blood pressure and heart rate while decreasing heart rate variability suggesting - but not proving - sympathetic mediation. The contribution of nicotine to these effects is unknown. Here the investigators will directly measure the acute effects of nicotine-free Hookah smoking on sympathetic nerve activity with microneurography (intraneural microelectrodes) and quantify associated regional changes in vasomotor tone.

研究设计

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

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 39 years of age
  • Habitual Hookah smoker defined as having smoked Hookah >=12 times in the past 12 months
  • Have not smoked cigarettes within the past 12 months

排除标准

  • Exhaled carbon monoxide level greater than 10 ppm* as evidence of current or recent cigarette (excluded if smoked cigarette within 12 months) or Hookah smoking (excluded if smoked Hookah within past 72 hours)
  • History of cardiopulmonary disease
  • Use of any prescription medication with exception of oral contraceptive pills
  • History of psychiatric illness
  • History of neurologic disease
  • Evidence of any of the above by physical examination, ECG or echocardiogram
  • Smoked cigarette in the past 12 months
  • History of illicit drug use
  • Any other condition(s) deemed by the physician investigators that put subjects at risk for participating in the study

结局指标

主要结局

Change in sympathetic nerve activity

时间窗: Change from baseline in sympathetic nerve activity at 1 hr

Multi-unit recordings of sympathetic nerve activity will be obtained with single-use sterile tungsten microelectrodes inserted selectively into muscle or skin nerve fascicles of the peritoneal nerve.

次要结局

  • Change in regional myocardial perfusion(Change from baseline in regional myocardial perfusion at 1 hr)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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