NCT02662075

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

January 20, 2016

Last Update Submit

January 26, 2017

Conditions

Smoking

Keywords

alternative tobacco products (ATPs)electronic cigarettes

Outcome Measures

Primary Outcomes (18)

  • 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

Study Arms (1)

E-cigarette/tobacco Smoking Exposure

EXPERIMENTAL
Device: E-cigarette/tobacco Smoking Exposure

Interventions

E-cigarette/tobacco Smoking ExposureDEVICE

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.

E-cigarette/tobacco Smoking Exposure

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult English speaking subjects able and willing to provide written informed consent
  • Active tobacco cigarette smoker
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

SmokingVaping

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Stuart Katz, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

  • Leon H Alviar, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2016

First Posted

January 25, 2016

Study Start

April 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 27, 2017

Record last verified: 2017-01

Locations

US(1)