Clinical trial NCT02662075: Effect of Electronic Cigarettes on Platelets, Endothelium and Inflammation
Official title: Acute Effects of Electronic Cigarettes on Platelet, Vascular Endothelial Function, and Inflammation in Healthy Active Smokers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Smoking
Keywords: alternative tobacco products (ATPs)
electronic cigarettes
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in measure of platelet aggregometry
timeFrame: 1 Day
measure: Change in Measure of Flow Cytometry
timeFrame: 1 Day
measure: Change in measure of Endothelial Function Assessment
timeFrame: 1 Day
measure: Change in measure of Inflammatory Marker Luminex panel-HS-CRP
timeFrame: 1 Day
measure: Change in measure of Inflammatory Marker Luminex panel- IL-6
timeFrame: 1 Day
measure: Change in measure of Inflammatory Marker Luminex panel- IL-8
timeFrame: 1 Day
measure: Change in measure of Inflammatory Marker Luminex panel- IL-10
timeFrame: 1 Day
measure: Change in measure of Inflammatory Marker IL-1b
timeFrame: 1 Day
measure: Change in measure of Inflammatory Marker- endothelin
timeFrame: 1 Day
measure: Change in measure of Inflammatory Marker- TNF-a
timeFrame: 1 Day
measure: Change in measure of Inflammatory Marker- vWF
timeFrame: 1 Day
measure: Change in measure of Inflammatory Marker- thrombomodulin
timeFrame: 1 Day
measure: Change in measure of Inflammatory Marker- E-selectin
timeFrame: 1 Day
measure: Change in measure of Inflammatory Marker- PAI-1
timeFrame: 1 Day
measure: 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
timeFrame: 1 Day
measure: Change in blood pressure measured with an automated blood pressure instrument
timeFrame: 1 Day
measure: Change in heart rate measured with an automated blood pressure instrument
timeFrame: 1 Day
measure: Change in pulse oxymetry measured with a pulse oximeter attached to the finger
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Stuart Katz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York University Medical School
name: Leon H Alviar, MD
role: PRINCIPAL_INVESTIGATOR
References: