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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02662075
Other study ID # 14-02083
Secondary ID
Status Withdrawn
Phase N/A
First received January 20, 2016
Last updated January 26, 2017
Start date April 2015
Est. completion date December 2016

Study information

Verified date January 2017
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Change in Measure of Flow Cytometry P-Selectin PAC-1 Platelet-Monocyte Aggregates 1 Day
Primary Change in measure of Endothelial Function Assessment Brachial artery flow mediated dilatation (BA-FMD) 1 Day
Primary Change in measure of Inflammatory Marker Luminex panel-HS-CRP 1 Day
Primary Change in measure of Inflammatory Marker Luminex panel- IL-6 1 Day
Primary Change in measure of Inflammatory Marker Luminex panel- IL-8 1 Day
Primary Change in measure of Inflammatory Marker Luminex panel- IL-10 1 Day
Primary Change in measure of Inflammatory Marker IL-1b 1 Day
Primary Change in measure of Inflammatory Marker- endothelin 1 Day
Primary Change in measure of Inflammatory Marker- TNF-a 1 Day
Primary Change in measure of Inflammatory Marker- vWF 1 Day
Primary Change in measure of Inflammatory Marker- thrombomodulin 1 Day
Primary Change in measure of Inflammatory Marker- E-selectin 1 Day
Primary Change in measure of Inflammatory Marker- PAI-1 1 Day
Primary 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
Primary Change in blood pressure measured with an automated blood pressure instrument 1 Day
Primary Change in heart rate measured with an automated blood pressure instrument 1 Day
Primary Change in pulse oxymetry measured with a pulse oximeter attached to the finger 1 Day
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