CompletedNot Applicable

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

United States55 participantsStarted 2022-06-07

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

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

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

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

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

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

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

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

Changes in blood inflammatory biomarkers

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

Trial details

NCT IDNCT05271578

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-06

View on ClinicalTrials.gov More Vascular Reactivity trials