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Effect of Electronic Cigarettes on Platelets, Endothelium and Inflammation

NCT02662075 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-01-27

No results posted yet for this study

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.

Conditions

  • Smoking

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Stuart Katz, MD · New York University Medical School

  • Leon H Alviar, MD · New York University Medical School

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02662075 on ClinicalTrials.gov