Vascular ReactivityAeCENCT05271578
MRI and Biological Markers of Acute E-Cigarette Exposure in Smokers and Vapers
A study testing Standardized Electronic Research Cigarette and Nicotine Research Cigarette in people with Vascular Reactivity and Serum Biomarkers, run by University of Pennsylvania at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Reactivity, Serum Biomarkers
- What is being tested?
- Standardized Electronic Research Cigarette and Nicotine Research Cigarette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2022to 28 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: 18.5 to 30
- Current users of electronic cigarettes or tobacco cigarettes with a use history of six months or greater.
Who cannot join
- 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
Show all 10Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Vascular Reactivity, Serum Biomarkers
- Being tested
- Standardized Electronic Research Cigarette, Nicotine Research Cigarette
- Keywords
- Magnetic Resonance Imaging, Electronic Cigarettes, Endothelial Dysfunction, Nicotine, Inflammation
- Medical subject headings
- Vaping, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Electronic Research CigaretteDevice
Also called SREC
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 CigaretteDevice
Also called NRC
Conventional Nicotine Tobacco Cigarette (National Institute of Drug Abuse, Drug Supply Program, Tobacco Product Master File #NRC600)
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Experimental | Conventional tobacco cigarette smokers Receives: Device: Standardized Electronic Research Cigarette; Device: Nicotine Research Cigarette |
| Vapers | Experimental | Electronic cigarette vapers Receives: Device: Standardized Electronic Research Cigarette; Device: Nicotine Research Cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Pre-Inhalation (baseline) to post-inhalation (60 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start7 Jun 2022
- Primary completion6 Jun 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular ReactivityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Felix W Wehrli, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271578
- Sponsor's protocol ID
- 850432
- Other IDs
- R01HL155243
- Acronym
- AeCE
- Status last verified
- Dec 2025
- First submitted
- 20 Jan 2022
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI and Biological Markers of Acute E-Cigarette Exposure in Smokers and Vapers
- ClinicalTrials.gov ID
- NCT05271578
- Acronym / sponsor ID
- AeCE / 850432
- Conditions
- Vascular Reactivity, Serum Biomarkers
- Keywords
- Magnetic Resonance Imaging, Electronic Cigarettes, Endothelial Dysfunction, Nicotine, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Smokers | Experimental | Device: Standardized Electronic Research Cigarette, Device: Nicotine Research CigaretteConventional tobacco cigarette smokers |
| Vapers | Experimental | Device: Standardized Electronic Research Cigarette, Device: Nicotine Research CigaretteElectronic cigarette vapers |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI: 18.5 to 30
- Current users of electronic cigarettes or tobacco cigarettes with a use history of six months or greater.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Electronic Research CigaretteAlso: SRECStandardized 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) | Device | Smokers, Vapers |
| Nicotine Research CigaretteAlso: NRCConventional Nicotine Tobacco Cigarette (National Institute of Drug Abuse, Drug Supply Program, Tobacco Product Master File #NRC600) | Device | Smokers, Vapers |
Primary outcome
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.
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.
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.
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix W Wehrli, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Electronic Research Cigarette and Nicotine Research Cigarette in people with Vascular Reactivity and Serum Biomarkers, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: aortic arch (time frame: Pre-Inhalation (baseline) to post-inhalation (60 minutes)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.