Coronary Artery Disease, Myocardial Perfusion
Conditions
Keywords
Myocardial perfusion, Electronic cigarettes, Cigarettes, Cigarette smoking
Brief summary
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.
Interventions
OTHERCigarettes
Subjects will smoke a standard cigarette (yield: tar 12 mg, nicotine 1 mg)
OTHERE-cigarettes (nicotine free e-liquid)
Subjects will smoke nicotine free e-liquid with an e-cigarette.
OTHERE-cigarettes (low nicotine e-liquid)
Subjects will smoke low nicotine (4-6 mg/mL) e-liquid with an e-cigarette.
OTHERE-cigarettes (high nicotine e-liquid)
Subjects will smoke low nicotine (18-24 mg/mL) e-liquid with an e-cigarette.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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) * Pregnant * Any other condition(s) deemed by the physician investigators that put subjects at risk for participating in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial Perfusion (change in microvascular flux rate from baseline at 30 minutes) | Baseline and 30 minutes after smoking | Myocardial contrast echocardiography will be used to measure regional myocardial perfusion - microvascular flux rate |
| Myocardial Perfusion (change in capillary blood volume from baseline at 30 minutes) | Baseline and 30 minutes after smoking | Myocardial contrast echocardiography will be used to measure regional myocardial perfusion - capillary blood volume |
Countries
United States
Outcome results
None listed