Acute Effects of Electronic Cigarettes on Platelet, Vascular Endothelial Function, and Inflammation in Healthy Active Smokers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- NYU Langone Health
- Locations
- 1
- Primary Endpoint
- Change in measure of Inflammatory Marker- endothelin
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Change in measure of Inflammatory Marker- endothelin
Time Frame: 1 Day
Change in measure of Inflammatory Marker- vWF
Time Frame: 1 Day
Change in measure of Inflammatory Marker- E-selectin
Time Frame: 1 Day
Change in measure of Inflammatory Marker- PAI-1
Time Frame: 1 Day
Change in measure of Inflammatory Marker IL-1b
Time Frame: 1 Day
Change in Measure of Flow Cytometry
Time Frame: 1 Day
P-Selectin PAC-1 Platelet-Monocyte Aggregates
Change in measure of Endothelial Function Assessment
Time Frame: 1 Day
Brachial artery flow mediated dilatation (BA-FMD)
Change in measure of Inflammatory Marker Luminex panel-HS-CRP
Time Frame: 1 Day
Change in measure of Inflammatory Marker Luminex panel- IL-8
Time Frame: 1 Day
Change in measure of Inflammatory Marker Luminex panel- IL-10
Time Frame: 1 Day
Change in measure of Inflammatory Marker- TNF-a
Time Frame: 1 Day
Change in measure of Inflammatory Marker- thrombomodulin
Time Frame: 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
Time Frame: 1 Day
Change in heart rate measured with an automated blood pressure instrument
Time Frame: 1 Day
Change in measure of platelet aggregometry
Time Frame: 1 Day
Platelet aggregation is part of the sequence of events leading to the formation of a thrombus (clot).
Change in blood pressure measured with an automated blood pressure instrument
Time Frame: 1 Day
Change in pulse oxymetry measured with a pulse oximeter attached to the finger
Time Frame: 1 Day
Change in measure of Inflammatory Marker Luminex panel- IL-6
Time Frame: 1 Day
Secondary Outcomes
No secondary outcomes reported