SmokingNCT02662075
Effect of Electronic Cigarettes on Platelets, Endothelium and Inflammation
A study testing E-cigarette/tobacco Smoking Exposure in people with Smoking, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- E-cigarette/tobacco Smoking Exposure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: 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.
- Conditions
- Smoking
- Being tested
- E-cigarette/tobacco Smoking Exposure
- Keywords
- alternative tobacco products (ATPs), electronic cigarettes
- Medical subject headings
- Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| E-cigarette/tobacco Smoking Exposure | Experimental | Not described Receives: Device: E-cigarette/tobacco Smoking Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in measure of platelet aggregometry
Platelet aggregation is part of the sequence of events leading to the formation of a thrombus (clot).
Measured: 1 Day
Change in Measure of Flow Cytometry
P-Selectin PAC-1 Platelet-Monocyte Aggregates
Measured: 1 Day
Change in measure of Endothelial Function Assessment
Brachial artery flow mediated dilatation (BA-FMD)
Measured: 1 Day
Change in measure of Inflammatory Marker Luminex panel-HS-CRP
Measured: 1 Day
Change in measure of Inflammatory Marker Luminex panel- IL-6
Measured: 1 Day
Change in measure of Inflammatory Marker Luminex panel- IL-8
Measured: 1 Day
Change in measure of Inflammatory Marker Luminex panel- IL-10
Measured: 1 Day
Change in measure of Inflammatory Marker IL-1b
Measured: 1 Day
Change in measure of Inflammatory Marker- endothelin
Measured: 1 Day
Change in measure of Inflammatory Marker- TNF-a
Measured: 1 Day
Change in measure of Inflammatory Marker- vWF
Measured: 1 Day
Change in measure of Inflammatory Marker- thrombomodulin
Measured: 1 Day
Change in measure of Inflammatory Marker- E-selectin
Measured: 1 Day
Change in measure of Inflammatory Marker- PAI-1
Measured: 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
Measured: 1 Day
Change in blood pressure measured with an automated blood pressure instrument
Measured: 1 Day
Change in heart rate measured with an automated blood pressure instrument
Measured: 1 Day
Change in pulse oxymetry measured with a pulse oximeter attached to the finger
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startApr 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart Katz, MD, Principal investigator, New York University Medical SchoolLeon H Alviar, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662075
- Sponsor's protocol ID
- 14-02083
- Status last verified
- Jan 2017
- First submitted
- 20 Jan 2016
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Electronic Cigarettes on Platelet, Vascular Endothelial Function, and Inflammation in Healthy Active Smokers
- ClinicalTrials.gov ID
- NCT02662075
- Acronym / sponsor ID
- 14-02083
- Conditions
- Smoking
- Keywords
- alternative tobacco products (ATPs), electronic cigarettes
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-cigarette/tobacco Smoking Exposure | Experimental | Device: E-cigarette/tobacco Smoking Exposure |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-cigarette/tobacco Smoking ExposureSubjects 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. | Device | E-cigarette/tobacco Smoking Exposure |
Primary outcome
Change in measure of platelet aggregometry
Time frame: 1 Day
Platelet aggregation is part of the sequence of events leading to the formation of a thrombus (clot).
Change in Measure of Flow Cytometry
Time frame: 1 Day
P-Selectin PAC-1 Platelet-Monocyte Aggregates
Change in measure of Endothelial Function Assessment
Time frame: 1 Day
Brachial artery flow mediated dilatation (BA-FMD)
Change in measure of Inflammatory Marker Luminex panel-HS-CRP
Time frame: 1 Day
Change in measure of Inflammatory Marker Luminex panel- IL-6
Time frame: 1 Day
Change in measure of Inflammatory Marker Luminex panel- IL-8
Time frame: 1 Day
Change in measure of Inflammatory Marker Luminex panel- IL-10
Time frame: 1 Day
Change in measure of Inflammatory Marker IL-1b
Time frame: 1 Day
Change in measure of Inflammatory Marker- endothelin
Time frame: 1 Day
Change in measure of Inflammatory Marker- TNF-a
Time frame: 1 Day
Change in measure of Inflammatory Marker- vWF
Time frame: 1 Day
Change in measure of Inflammatory Marker- thrombomodulin
Time frame: 1 Day
Change in measure of Inflammatory Marker- E-selectin
Time frame: 1 Day
Change in measure of Inflammatory Marker- PAI-1
Time frame: 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
Time frame: 1 Day
Change in blood pressure measured with an automated blood pressure instrument
Time frame: 1 Day
Change in heart rate measured with an automated blood pressure instrument
Time frame: 1 Day
Change in pulse oxymetry measured with a pulse oximeter attached to the finger
Time frame: 1 Day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Katz, MD principal investigator
New York University Medical School
Leon H Alviar, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-cigarette/tobacco Smoking Exposure in people with Smoking, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in measure of platelet aggregometry (time frame: 1 Day). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2017.