Back to resultsEffect of Electronic Cigarettes on Platelets, Endothelium and Inflammation
Primary Purpose
Smoking
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
E-cigarette/tobacco Smoking Exposure
Sponsored by
About this trial
This is an interventional other trial for Smoking focused on measuring alternative tobacco products (ATPs), electronic cigarettes
Eligibility Criteria
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
E-cigarette/tobacco Smoking Exposure
Arm Description
Outcomes
Primary Outcome Measures
Change in measure of platelet aggregometry
Platelet aggregation is part of the sequence of events leading to the formation of a thrombus (clot).
Change in Measure of Flow Cytometry
P-Selectin PAC-1 Platelet-Monocyte Aggregates
Change in measure of Endothelial Function Assessment
Brachial artery flow mediated dilatation (BA-FMD)
Change in measure of Inflammatory Marker Luminex panel-HS-CRP
Change in measure of Inflammatory Marker Luminex panel- IL-6
Change in measure of Inflammatory Marker Luminex panel- IL-8
Change in measure of Inflammatory Marker Luminex panel- IL-10
Change in measure of Inflammatory Marker IL-1b
Change in measure of Inflammatory Marker- endothelin
Change in measure of Inflammatory Marker- TNF-a
Change in measure of Inflammatory Marker- vWF
Change in measure of Inflammatory Marker- thrombomodulin
Change in measure of Inflammatory Marker- E-selectin
Change in measure of Inflammatory Marker- PAI-1
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
Change in blood pressure measured with an automated blood pressure instrument
Change in heart rate measured with an automated blood pressure instrument
Change in pulse oxymetry measured with a pulse oximeter attached to the finger
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02662075
Brief Title
Effect of Electronic Cigarettes on Platelets, Endothelium and Inflammation
Official Title
Acute Effects of Electronic Cigarettes on Platelet, Vascular Endothelial Function, and Inflammation in Healthy Active Smokers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Study Start Date
April 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking
Keywords
alternative tobacco products (ATPs), electronic cigarettes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E-cigarette/tobacco Smoking Exposure
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
E-cigarette/tobacco Smoking Exposure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in measure of platelet aggregometry
Description
Platelet aggregation is part of the sequence of events leading to the formation of a thrombus (clot).
Time Frame
1 Day
Title
Change in Measure of Flow Cytometry
Description
P-Selectin PAC-1 Platelet-Monocyte Aggregates
Time Frame
1 Day
Title
Change in measure of Endothelial Function Assessment
Description
Brachial artery flow mediated dilatation (BA-FMD)
Time Frame
1 Day
Title
Change in measure of Inflammatory Marker Luminex panel-HS-CRP
Time Frame
1 Day
Title
Change in measure of Inflammatory Marker Luminex panel- IL-6
Time Frame
1 Day
Title
Change in measure of Inflammatory Marker Luminex panel- IL-8
Time Frame
1 Day
Title
Change in measure of Inflammatory Marker Luminex panel- IL-10
Time Frame
1 Day
Title
Change in measure of Inflammatory Marker IL-1b
Time Frame
1 Day
Title
Change in measure of Inflammatory Marker- endothelin
Time Frame
1 Day
Title
Change in measure of Inflammatory Marker- TNF-a
Time Frame
1 Day
Title
Change in measure of Inflammatory Marker- vWF
Time Frame
1 Day
Title
Change in measure of Inflammatory Marker- thrombomodulin
Time Frame
1 Day
Title
Change in measure of Inflammatory Marker- E-selectin
Time Frame
1 Day
Title
Change in measure of Inflammatory Marker- PAI-1
Time Frame
1 Day
Title
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
Time Frame
1 Day
Title
Change in blood pressure measured with an automated blood pressure instrument
Time Frame
1 Day
Title
Change in heart rate measured with an automated blood pressure instrument
Time Frame
1 Day
Title
Change in pulse oxymetry measured with a pulse oximeter attached to the finger
Time Frame
1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Katz, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leon H Alviar, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Electronic Cigarettes on Platelets, Endothelium and Inflammation
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