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
- 1
- 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
研究组 & 干预措施
E-cigarettes (high nicotine e-liquid)
Healthy chronic dual cigarette and e-cigarette smokers will undergo myocardial contrast echocardiography before and after smoking high concentration (18-24 mg/mL) e-cigarette liquid.
干预措施: E-cigarettes (high nicotine e-liquid) (Other)
Cigarettes
Healthy chronic dual cigarette and e-cigarette smokers will undergo myocardial contrast echocardiography before and after smoking two standard cigarettes
干预措施: Cigarettes (Other)
E-cigarettes (nicotine free e-liquid)
Healthy chronic dual cigarette and e-cigarette smokers will undergo myocardial contrast echocardiography before and after smoking nicotine free e-cigarette liquid.
干预措施: E-cigarettes (nicotine free e-liquid) (Other)
E-cigarettes (low nicotine e-liquid)
Healthy chronic dual cigarette and e-cigarette smokers will undergo myocardial contrast echocardiography before and after smoking low concentration(4-6 mg/mL) e-cigarette liquid.
干预措施: E-cigarettes (low nicotine e-liquid) (Other)
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