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Completed

NCT Number: NCT03479203

Acute Effects of E-Cigarette Aerosol Inhalation

This study comprises a portion of a larger study designed to compare results of vascular function in non-smokers to vascular function in healthy smokers chronically exposed to nicotinized electronic cigarette aerosol versus conventional cigarettes.

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Key information

Conditions

Endothelial Dysfunction Biochemical Markers Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

About this study

Here, we 1) investigate the acute effects of non-nicotinized e-cigarette aerosol inhalation in nonsmokers in terms of blood-based markers of inflammation and oxidative stress, and 2) evaluate their association with hemodynamic-metabolic MRI parameters quantifying peripheral vascular reactivity, cerebrovascular reactivity, and aortic stiffness.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI of 18.5 - 30

Exclusion criteria

  • Cancer
  • HIV
  • Mental illness
  • Overt cardio- or neurovascular disease (prior heart attack, stroke, transient ischemic attacks)
  • Serious arrhythmias
  • Bronchospastic disease
  • Upper respiratory tract infection within the past six weeks
  • Chronic medication or antibiotics
  • Claustrophobia / contraindications for MRI

Treatment and study plan

Electronic Cigarette Aerosol

Drug

16 two-second-long puffs from a non-nicotinized electronic cigarette.

Primary outcomes

  1. Inflammatory Blood-Based Biomarkers

    Time frame: Participant blood draws occurred at two time points: 1) pre-vaping, 2) 120 minutes post-vaping. Inflammation index is calculated from the fold change in biomarker values over pre-vaping values

    Post-vaping inflammation monitored by changes in an integrated cluster of blood-based biomarkers from serum/plasma of non-smoking healthy participants quantified at 0 and 120 min post-inhalation. The cluster consisted of: CRP, sICAM-1 in serum and HMGB1, ASC in plasma assayed using ELISA and quantified using absorbance-concentration curves generated by the manufacturers' standards; nitric oxide metabolites (nitrate + nitrite, NOx) in serum assayed with a nitrate/nitrite kit using a colorimetric standard provided by the manufacturer; reactive oxygen species (ROS) was quantified by using immortalized human pulmonary microvascular endothelial cells plated, prepared with serum, labeled with ROS dye and imaged confocal fluorescence microscopy.

    The outcome measure was expressed as fold increase over pre-vaping values.

  2. Acute Change in Aortic Pulse Wave Velocity Post-vaping

    Time frame: PWV calculation occurred at two time points: 1) pre-vaping, 2) Fifteen minutes post-vaping.

    Central arterial stiffness was assessed using aortic pulse-wave velocity (PWV), a biomarker of aortic stiffness calculated by measuring the velocity of a pulse wave between two points in the same artery. A higher aortic pulse wave velocity equates to a stiffer aorta.

    In each participant, aortic PWV was quantified, pre- and post-vaping, by dividing the path length of the aortic arch determined from a oblique sagittal image, by the transit time of the pulse pressure wave. Measurements obtained pre-vaping were compared to those obtained post-vaping.

  3. Change in Femoral Artery Flow-Mediated Dilation Post-Vaping

    Time frame: Flow mediated dilation calculation occurred at two time points: 1) pre-vaping, 2) 40 minutes post-vaping.

    Degree of dilation (% change in cross-sectional area) of femoral artery during hyperemia (the transient increase in blood flow velocity) after e-cigarette vaping as compared to before e-cigarette vaping.

  4. Change in Washout Time Post-Vaping

    Time frame: Washout time calculation occurred at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping

    Transit time of desaturated capillary blood from tissue to the imaging location after e-cigarette vaping

  5. Change in Upslope Post-Vaping

    Time frame: Upslope was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping

    Tissue oxygen resaturation rate after e-cigarette vaping.

  6. Change in Overshoot Post-Vaping

    Time frame: Overshoot was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping.

    Degree of overcompensatory effect post-vaping in the supply of oxygen after ischemia.

  7. Change in Breath Hold Index Post-Vaping

    Time frame: Breath hold index was calculated at two time points: 1) pre-vaping, 2) five minutes post-vaping.

    Rate of increase in blood flow velocity in the superior sagittal sinus from intermittent volitional apnea.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Acute and Long-term Effects of E-Cigarette Aerosol Inhalation on Biomarkers of Endothelial Function and Vascular Reactivity

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 27, 2018
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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