Effect of Electronic Cigarettes on Platelets, Endothelium and Inflammation

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate the acute effects of electronic cigarette (e-cigarette) smoking on measurable biomarkers of platelet function, vascular endothelial function and inflammation in healthy active smokers. 10 healthy subjects, smokers, with no other medical conditions will be included in this study and measurements will be obtained at baseline and after smoking an e-cigarette. The study will contribute to the understanding of the effects of e-cigarettes on cardiovascular physiology, specifically establishing if the use of e-cigarettes increases platelet aggregation and platelet activation when compared to baseline in healthy active smokers, if the use of e-cigarettes decreases brachial artery flow-mediated dilation compared to baseline in healthy active smokers, and to determine the association between biomarkers of inflammation, platelet function, and vascular endothelial function before and after use of e-cigarettes.

Official Title
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Acute Effects of Electronic Cigarettes on Platelet, Vascular Endothelial Function, and Inflammation in Healthy Active Smokers

Conditions
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Smoking

Intervention / Treatment
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* Device: E-cigarette/tobacco Smoking Exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult English speaking subjects able and willing to provide written informed consent Active tobacco cigarette smoker History of active smoking tobacco cigarettes for 3-10 years (at least 10 cigarettes per day). The rational for inclusion of active smokers is based on prior data showing that most e-cigarette users have smoked moderate to high amount of tobacco cigarettes in the past No other use of alternative tobacco or nicotine products No history of hypertension, diabetes, cardiovascular disease, stroke, peripheral arterial disease, asthma or other chronic lung disease. Exclusion Criteria: Use of aspirin, clopidogrel, prasugrel, ticagrelor, warfarin, statins, colchicine, nitrates, steroids, fish oil, omega-3 fatty acids, or any other anti-inflammatory, antithrombotic or anticoagulant agent in the last week History of adverse reactions to e-cigarettes

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-cigarette/tobacco Smoking Exposure<br> | Device: E-cigarette/tobacco Smoking Exposure<br>* Subjects will be asked to smoke an e-cigarette containing the equivalence of nicotine in one tobacco cigarette (15 puffs) in the presence of research staff. Each puff will be timed at 4 seconds and there should be a 20-30 seconds interpuff interval as previously recommended.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in measure of platelet aggregometry | Platelet aggregation is part of the sequence of events leading to the formation of a thrombus (clot). | 1 Day | 
| Change in Measure of Flow Cytometry | P-Selectin PAC-1 Platelet-Monocyte Aggregates | 1 Day | 
| Change in measure of Endothelial Function Assessment | Brachial artery flow mediated dilatation (BA-FMD) | 1 Day | 
| Change in measure of Inflammatory Marker Luminex panel-HS-CRP |  | 1 Day | 
| Change in measure of Inflammatory Marker Luminex panel- IL-6 |  | 1 Day | 
| Change in measure of Inflammatory Marker Luminex panel- IL-8 |  | 1 Day | 
| Change in measure of Inflammatory Marker Luminex panel- IL-10 |  | 1 Day | 
| Change in measure of Inflammatory Marker IL-1b |  | 1 Day | 
| Change in measure of Inflammatory Marker- endothelin |  | 1 Day | 
| Change in measure of Inflammatory Marker- TNF-a |  | 1 Day | 
| Change in measure of Inflammatory Marker- vWF |  | 1 Day | 
| Change in measure of Inflammatory Marker- thrombomodulin |  | 1 Day | 
| Change in measure of Inflammatory Marker- E-selectin |  | 1 Day | 
| Change in measure of Inflammatory Marker- PAI-1 |  | 1 Day | 
| Change in brachial artery flow mediated dilatation measured non-invasively with a ultrasound probe at rest and after inflation of a forearm blood pressure cuff to 50 mm Hg above measured systolic blood pressure for 5 minutes |  | 1 Day | 
| Change in blood pressure measured with an automated blood pressure instrument |  | 1 Day | 
| Change in heart rate measured with an automated blood pressure instrument |  | 1 Day | 
| Change in pulse oxymetry measured with a pulse oximeter attached to the finger |  | 1 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alternative tobacco products (ATPs), electronic cigarettes