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

Serum Biomarkers Clinical Trial

— AeCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05271578
• Other study ID #: 850432
• Secondary ID: R01HL155243
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2022
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: Jessica Nunez
• Phone: 215-746-6788
• Email: jessica.nunez[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Serum Biomarkers
• Vascular Reactivity

Intervention

Device:
• Standardized Electronic Research Cigarette
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)
• Nicotine Research Cigarette
Conventional Nicotine Tobacco Cigarette (National Institute of Drug Abuse, Drug Supply Program, Tobacco Product Master File #NRC600)

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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 1ß, interleukin 18, interferon gamma, monocyte chemoattractant protein, and macrophage inflammatory protein).	Pre-Inhalation (baseline) to post-inhalation (60 minutes)