Effect of Electronic Cigarettes on Platelets, Endothelium and Inflammation

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

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 Overview

• Status: Withdrawn
• Conditions: Smoking
• Intervention / Treatment: Device: E-cigarette/tobacco Smoking Exposure

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E-cigarette/tobacco Smoking Exposure	Device: E-cigarette/tobacco Smoking Exposure; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Stuart Katz, MD, New York University Medical School; Principal Investigator: Leon H Alviar, MD, New York University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 20, 2016
• First Submitted That Met QC Criteria: January 20, 2016
• First Posted (Estimate): January 25, 2016

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: alternative tobacco products (ATPs); electronic cigarettes
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 14-02083