跳至主要内容
临床试验/NCT04175457
NCT04175457已完成不适用

The Acute Effects of E-cigarette Inhalation on Vascular Function, Microcirculation and Thrombosis

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年12月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
microcirculation

研究概览

简要总结

This is a human randomized controlled cross-over study where the effects of e-cigarette inhalation (with or without nicotine) on vascular function, microcirculation and thrombosis is assessed.

详细描述

Twenty-two healthy, female and male occasional smokers or snus users (age 18-55, 10 cigarettes per month, 10 pouches of snus per month) will be included. Research subjects are required to refrain from intake of alcohol and caffeine during at least 24 hours prior to the exposure. Tobacco usage (including Swedish moist snuff) or e-cigarette usage is not permitted within 7 days prior to exposure.

All subjects have to complete a normal health declaration.

In a randomized cross-over fashion, all subjects will inhale vapor (30 puffs for 30 minutes) from one electronic cigarette, eVic-Primo SE (Shenzhen Joyetech Co., Ltd., China). in a specially prepared room with adequate ventilation.

There are plenty e-liquid manufacturers and distributors on the market. Independent content analysis showed that nicotine variation across e-liquid batches is low and that the amount of nicotine as stated by the manufacturer often is correct. E- liquid without any flavourings (Valeo laboratories GmbH, Germany) without and with nicotine (19 mg/ml) will be used. Content analysis is free available on the manufacturers homepage (http://www.e-liquid-wholesale.com). A third-generation EC is used with settings (Temperature 230°C, Effect 32 W, Resistance 0,20 Ω).

Research subjects are required to refrain from intake of alcohol during at least 24 hours prior to the exposure sequences, as well as caffeine for 12 hours. The two occasions will be separated by at least one week. Subjects rest for 15 minutes preceding the exposure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Normal health declaration

排除标准

  • •Any form of cardiovascular disease
  • •Any form of pulmonary disease like asthma or COPD
  • •Any form of systemic or chronic disorder like rheumatologic or metabolic diseases. - Symptoms of infection or inflammation within 4 weeks of the study
  • •Pregnancy

研究组 & 干预措施

e-cigarette inhalation with nicotine

Experimental

inhalation of e-cigarette vapor with nicotine for 30 minutes.

干预措施: e-cigarette (Other)

e-cigarette inhalation without nicotine

Active Comparator

inhalation of e-cigarette vapor without nicotine for 30 minutes.

干预措施: e-cigarette (Other)

结局指标

主要结局

microcirculation

时间窗: change from baseline and 1 hour following exposures

Iontophoresis and laser speckle contrast imaging (LSCI), Measurement of capillary blood flow (Capiflow), GlycoCheck system

thrombosis (total thrombus formation analysis system)

时间窗: change from baseline, 30 minutes and 2 hour following exposures

T-TAS (area under the curve, flow pressure change)

次要结局

  • Microvesicles(change from baseline, 30 minutes and 2 hour following exposures)
  • NETs(neutrophil extracellular traps)(change from baseline, 30 minutes and 2 hour following exposures)
  • capillary microscopy(change from baseline to 1 hour following exposures)
  • arterial stiffness(change from baseline up to 3 hours following exposures)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Magnus Lundbäck

MD, Associate Professor

Karolinska Institutet

研究点 (1)

Loading locations...

相似试验