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Completed

NCT Number: NCT05271578

MRI and Biological Markers of Acute E-Cigarette Exposure in Smokers and Vapers

To examine vascular reactivity and inflammatory biomarkers via quantitative magnetic resonance imaging (MRI) and blood serum, respectively, in a crossover study where active vapers (electronic cigarette users) and smokers will undergo three separate acute exposure-episodes of electronic cigarette +/- nicotine and tobacco-cig. The MRI exams and blood draws will be performed pre- and post-exposure. The results will be compared against baseline values derived from a group of non-smokers/non-vapers, who will also undergo a blood draw and MRI.

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Key information

Conditions

Vascular Reactivity Behavior Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Serum Biomarkers Smoking Vaping

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

This work is an extension of prior funded work on the acute effects of nicotine free electronic cigarette aerosol on vascular function and inflammatory biomarkers in healthy non-smokers. Here, the investigators will examine vascular reactivity and inflammatory biomarkers using quantitative magnetic resonance imagine (MRI) and blood serum in a crossover study, with active vapers (electronic cigarette users) and smokers undergoing three, separate-day, acute exposure-episodes of smoking a tobacco cigarette, an electronic cigarette without nicotine, and an electronic cigarette with nicotine. Participants will undergo an MRI exam and a blood draw pre- and post-exposure-episode.

The investigators hypothesize that all three paradigms will cause a transient response but greatest for tobacco and nicotinized electronic cigarettes. The results will be compared against baseline values derived from a group of non-smokers/non-vapers, who will undergo a blood draw and MRI only. Eligible participants will be healthy, males and females, current, habitual users of electronic or tobacco cigarettes (except for the non-smoking/non-vaping comparison group), 21 to 45 years of age, and without co-morbidities.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI: 18.5 to 30
  • Current users of electronic cigarettes or tobacco cigarettes with a use history of six months or greater.

Exclusion criteria

  • Cancer
  • HIV
  • Mental illness in which the participant is not of proper cognizance
  • 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
  • Medication affecting vascular function
  • Antibiotics
  • Magnetic resonance imaging contraindications (metallic implants/intraocular foreign bodies, claustrophobia, cardiac/cochlear implantable electronic devices, etc.)

Treatment and study plan

Standardized Electronic Research Cigarette

Device

Standardized Research Electronic Cigarette Device, Standardized Research Electronic Cigarette Tobacco 5%, Standardized Research Electronic Cigarette Tobacco (placebo) 0% (NJOY, LLC, Tobacco Product Master File #STN MF0000274)

Other names: SREC

Nicotine Research Cigarette

Device

Conventional Nicotine Tobacco Cigarette (National Institute of Drug Abuse, Drug Supply Program, Tobacco Product Master File #NRC600)

Other names: NRC

Primary outcomes

  1. Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: aortic arch

    Time frame: Pre-Inhalation (baseline) to post-inhalation (60 minutes)

    Changes in stiffness of aortic arch in terms of pulse-wave velocity measured in meters per second.

  2. Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: cerebral vascular reactivity

    Time frame: Pre-Inhalation (baseline) to post-inhalation (60 minutes)

    Rate of change in the blood flow velocity [centimeters per second (squared)] in a major draining vein in response to volitional apnea.

  3. Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: femoral artery flow-mediated dilation

    Time frame: Pre-Inhalation (baseline) to post-inhalation (60 minutes)

    Percentage measure of the change of a cross-sectional area of the superficial femoral artery.

  4. Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: venous oxygen saturation

    Time frame: Pre-Inhalation (baseline) to post-inhalation (60 minutes)

    Assessment of microvascular function by monitoring the changes in tissue blood oxygenation measured in percentage in response to a cuff-induced ischemia.

  5. Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: blood flow velocity

    Time frame: Pre-Inhalation (baseline) to post-inhalation (60 minutes)

    Macrovascular function is evaluated by monitoring hyperemia in response to a cuff-induced ischemia by measuring femoral artery blood flow velocity in centimeters per second.

  6. Changes in blood inflammatory biomarkers

    Time frame: Pre-Inhalation (baseline) to post-inhalation (60 minutes)

    Measured in nanograms/milliliter of plasma, the following biomarkers are collectively associated with damage to blood vessels and recruitment of immune cells into the vascular tissue leading to severe oxidative stress and tissue damage in the vasculature: biomarker of oxidative stress (c-reactive protein) and biomarkers of inflammation (NLR family pyrin domain containing 3, damage-associated molecular pattern protein HMGB1, tumor necrosis factor alpha, interleukin 1β, interleukin 18, interferon gamma, monocyte chemoattractant protein, and macrophage inflammatory protein).

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

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

Registry information

Acronym: AeCE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 9, 2022
Registry last updated
Dec 16, 2025

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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