E-Cigarette Aerosol, Conventional Cigarette Smoke, and Myocardial Perfusion
Stopped early · Not applicable
Conditions studied: Coronary Artery Disease, Myocardial Perfusion
In brief
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.
Key facts
- Study ID
- NCT02612701
- Run by
- Cedars-Sinai Medical Center
- People needed
- 20
- Starts
- 2015-10-01
- Expected to finish
- 2020-10-01
- Last updated by the study team
- 2021-02-04
Who can join
Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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