E-Cigarette Aerosol, Conventional Cigarette Smoke, and Myocardial Perfusion
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Myocardial Perfusion (change in capillary blood volume from baseline at 30 minutes)
研究概览
简要总结
E-cigarettes deliver nicotine by creating an aerosol of ultrafine particles. Many questions remain about the size and composition and especially about the potential toxicity of these particles. Thus, a key unanswered question-and the research question proposed-is whether e-cigarette aerosol triggers the same acute impairment in coronary microvessel function as does conventional cigarette smoke, which delivers a very well-defined exposure to fine particles and many fold greater exposure to toxic (combustion) products including volatile organic compounds (such as acrolein) that have been implicated in the pathogenesis of tobacco-related coronary disease.
Because the effects of nicotine on the human coronary microcirculation remain incompletely defined-with multiple potential vasodilator and vasoconstrictor actions each of which may vary by dose-we will determine the comparative effects of conventional cigarette smoke against e-cigarette aerosol with no nicotine, with low-dose nicotine, and with high-dose nicotine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-49
- •Regular cigarette smoker defined as at least 1 pack year and ≥ 5/day
- •E-cigarette smoker defined as ≥ 1/week in the last 6 months.
排除标准
- •Sub-optimal echocardiography images as determined by the sonographer and/or investigators.
- •History of cardiopulmonary (including asthma or use of inhalers),
- •History of diabetes or dyslipidemia
- •History of psychiatric illness
- •Blood Pressure > 140/90
- •Body Mass Index ≤ 18.5 or ≥ 30 kg•m2
- •Evidence of any of the above by physical examination, Electrocardiogram (ECG) or echocardiogram
- •Resting Heart Rate > 100 beats/min
- •Cardiac rhythm disorder, specifically: rhythm other than sinus, Supraventricular Tachycardia (SVT), atrial fibrillation, ventricular tachycardia
- •Use of prescription medication except oral contraceptive pills
- •History of illicit drug use (self-stated)
- •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
Myocardial Perfusion (change in capillary blood volume from baseline at 30 minutes)
时间窗: Baseline and 30 minutes after smoking
Myocardial contrast echocardiography will be used to measure regional myocardial perfusion - capillary blood volume
Myocardial Perfusion (change in microvascular flux rate from baseline at 30 minutes)
时间窗: Baseline and 30 minutes after smoking
Myocardial contrast echocardiography will be used to measure regional myocardial perfusion - microvascular flux rate
次要结局
未报告次要终点
研究者
Florian Rader
M.D, M.Sc.
Cedars-Sinai Medical Center