The Acute Effects of E-cigarette Inhalation on Vascular Function, Microcirculation and Thrombosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- microcirculation
Study Overview
Brief Summary
This is a human randomized controlled cross-over study where the effects of e-cigarette inhalation (with or without nicotine) on vascular function, microcirculation and thrombosis is assessed.
Detailed Description
Twenty-two healthy, female and male occasional smokers or snus users (age 18-55, 10 cigarettes per month, 10 pouches of snus per month) will be included. Research subjects are required to refrain from intake of alcohol and caffeine during at least 24 hours prior to the exposure. Tobacco usage (including Swedish moist snuff) or e-cigarette usage is not permitted within 7 days prior to exposure.
All subjects have to complete a normal health declaration.
In a randomized cross-over fashion, all subjects will inhale vapor (30 puffs for 30 minutes) from one electronic cigarette, eVic-Primo SE (Shenzhen Joyetech Co., Ltd., China). in a specially prepared room with adequate ventilation.
There are plenty e-liquid manufacturers and distributors on the market. Independent content analysis showed that nicotine variation across e-liquid batches is low and that the amount of nicotine as stated by the manufacturer often is correct. E- liquid without any flavourings (Valeo laboratories GmbH, Germany) without and with nicotine (19 mg/ml) will be used. Content analysis is free available on the manufacturers homepage (http://www.e-liquid-wholesale.com). A third-generation EC is used with settings (Temperature 230°C, Effect 32 W, Resistance 0,20 Ω).
Research subjects are required to refrain from intake of alcohol during at least 24 hours prior to the exposure sequences, as well as caffeine for 12 hours. The two occasions will be separated by at least one week. Subjects rest for 15 minutes preceding the exposure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Normal health declaration
Exclusion Criteria
- •Any form of cardiovascular disease
- •Any form of pulmonary disease like asthma or COPD
- •Any form of systemic or chronic disorder like rheumatologic or metabolic diseases. - Symptoms of infection or inflammation within 4 weeks of the study
- •Pregnancy
Arms & Interventions
e-cigarette inhalation with nicotine
inhalation of e-cigarette vapor with nicotine for 30 minutes.
Intervention: e-cigarette (Other)
e-cigarette inhalation without nicotine
inhalation of e-cigarette vapor without nicotine for 30 minutes.
Intervention: e-cigarette (Other)
Outcomes
Primary Outcomes
microcirculation
Time Frame: change from baseline and 1 hour following exposures
Iontophoresis and laser speckle contrast imaging (LSCI), Measurement of capillary blood flow (Capiflow), GlycoCheck system
thrombosis (total thrombus formation analysis system)
Time Frame: change from baseline, 30 minutes and 2 hour following exposures
T-TAS (area under the curve, flow pressure change)
Secondary Outcomes
- Microvesicles(change from baseline, 30 minutes and 2 hour following exposures)
- NETs(neutrophil extracellular traps)(change from baseline, 30 minutes and 2 hour following exposures)
- capillary microscopy(change from baseline to 1 hour following exposures)
- arterial stiffness(change from baseline up to 3 hours following exposures)
Investigators
Magnus Lundbäck
MD, Associate Professor
Karolinska Institutet