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

NCT05271578 | Completed

• 2 other identifiers: 850432R01HL155243
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Reactivity; Serum Biomarkers

Keywords

Magnetic Resonance Imaging; Electronic Cigarettes; Endothelial Dysfunction; Nicotine; Inflammation

Outcome Measures

Primary Outcomes (6)

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

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

  Pre-Inhalation (baseline) to post-inhalation (60 minutes)

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

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

  Pre-Inhalation (baseline) to post-inhalation (60 minutes)

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

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

  Pre-Inhalation (baseline) to post-inhalation (60 minutes)

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

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

  Pre-Inhalation (baseline) to post-inhalation (60 minutes)

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

  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.

  Pre-Inhalation (baseline) to post-inhalation (60 minutes)

• Changes in blood inflammatory biomarkers

  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).

  Pre-Inhalation (baseline) to post-inhalation (60 minutes)

Study Arms (2)

Smokers

EXPERIMENTAL

Conventional tobacco cigarette smokers

Device: Standardized Electronic Research Cigarette; Device: Nicotine Research Cigarette

Vapers

EXPERIMENTAL

Electronic cigarette vapers

Device: Standardized Electronic Research Cigarette; Device: Nicotine Research Cigarette

Interventions

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)

Also known as: SREC

Smokers; Vapers

Nicotine Research Cigarette DEVICE

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

Also known as: NRC

Smokers; Vapers

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Vaping; Inflammation

Condition Hierarchy (Ancestors)

Smoking; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Felix W Wehrli, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding to nicotine and placebo containing standardized electronic research cigarettes and standardized tobacco research cigarettes.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be conducted in a three-period crossover design and will involve active e-cig (electronic cigarette) and tobacco cigarette users undergoing three different interventions (blinded to the investigators). The three periods will consist of (1) electronic cigarette vaping without nicotine, (2) electronic cigarette vaping with nicotine, (3) tobacco cigarette smoking. Sequence order will be established by means of a computer-generated randomization scheme.

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: March 9, 2022
• Study Start: June 7, 2022
• Primary Completion: June 6, 2025
• Study Completion: November 28, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)