Clinical trial NCT02612701: E-Cigarette Aerosol, Conventional Cigarette Smoke, and Myocardial Perfusion
Official title: E-Cigarette Aerosol, Conventional Cigarette Smoke, and Myocardial Perfusion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Perfusion
Keywords: Myocardial perfusion
Electronic cigarettes
Cigarettes
Cigarette smoking
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Myocardial Perfusion (change in microvascular flux rate from baseline at 30 minutes)
timeFrame: Baseline and 30 minutes after smoking
measure: Myocardial Perfusion (change in capillary blood volume from baseline at 30 minutes)
timeFrame: Baseline and 30 minutes after smoking
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Florian Rader, MD
role: PRINCIPAL_INVESTIGATOR
References: