Effect of Electronic Cigarettes on Platelets, Endothelium and Inflammation

Not Applicable

Withdrawn

• Conditions: Smoking
• Interventions: Device: E-cigarette/tobacco Smoking Exposure

• Registration Number: NCT02662075
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-20
• Study First Posted: 2016-01-25
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E-cigarette/tobacco Smoking Exposure	E-cigarette/tobacco Smoking Exposure	-

Primary Outcome Measures

Name	Time	Method
Change in measure of Inflammatory Marker- endothelin	1 Day
Change in measure of Inflammatory Marker- vWF	1 Day
Change in measure of Inflammatory Marker- E-selectin	1 Day
Change in measure of Inflammatory Marker- PAI-1	1 Day
Change in measure of Inflammatory Marker IL-1b	1 Day
Change in Measure of Flow Cytometry	1 Day	P-Selectin PAC-1 Platelet-Monocyte Aggregates
Change in measure of Endothelial Function Assessment	1 Day	Brachial artery flow mediated dilatation (BA-FMD)
Change in measure of Inflammatory Marker Luminex panel-HS-CRP	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- TNF-a	1 Day
Change in measure of Inflammatory Marker- thrombomodulin	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 heart rate measured with an automated blood pressure instrument	1 Day
Change in measure of platelet aggregometry	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	1 Day
Change in pulse oxymetry measured with a pulse oximeter attached to the finger	1 Day
Change in measure of Inflammatory Marker Luminex panel- IL-6	1 Day

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States