Clinical trial NCT05271578: MRI and Biological Markers of Acute E-Cigarette Exposure in Smokers and Vapers
Official title: MRI and Biological Markers of Acute E-Cigarette Exposure in Smokers and Vapers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vascular Reactivity
Serum Biomarkers
Keywords: Magnetic Resonance Imaging
Electronic Cigarettes
Endothelial Dysfunction
Nicotine
Inflammation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-03-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

Detailed description: 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: aortic arch
timeFrame: Pre-Inhalation (baseline) to post-inhalation (60 minutes)
measure: Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: cerebral vascular reactivity
timeFrame: Pre-Inhalation (baseline) to post-inhalation (60 minutes)
measure: Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: femoral artery flow-mediated dilation
timeFrame: Pre-Inhalation (baseline) to post-inhalation (60 minutes)
measure: Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: venous oxygen saturation
timeFrame: Pre-Inhalation (baseline) to post-inhalation (60 minutes)
measure: Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: blood flow velocity
timeFrame: Pre-Inhalation (baseline) to post-inhalation (60 minutes)
measure: Changes in blood inflammatory biomarkers
timeFrame: Pre-Inhalation (baseline) to post-inhalation (60 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Felix W Wehrli, PhD
role: PRINCIPAL_INVESTIGATOR
References: