An Early Phase 1 interventional study of Electronic Cigarette Aerosol in Endothelial Dysfunction and Biochemical Markers, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University of Pennsylvania · Early Phase 1, Interventional, and Basic science
This study comprises a portion of a larger study designed to compare results of vascular function in non-smokers to vascular function in healthy smokers chronically exposed to nicotinized electronic cigarette aerosol versus conventional cigarettes.
Here, we 1) investigate the acute effects of non-nicotinized e-cigarette aerosol inhalation in nonsmokers in terms of blood-based markers of inflammation and oxidative stress, and 2) evaluate their association with hemodynamic-metabolic MRI parameters quantifying peripheral vascular reactivity, cerebrovascular reactivity, and aortic stiffness.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's enrollment of 31 is below the median of 50 across 2,577 interventional studies indexed under Inflammation.
Browse Inflammation studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Non-nicotinized electronic cigarette aerosol (16 2-second long puffs)
Drug: Electronic Cigarette Aerosol
16 two-second-long puffs from a non-nicotinized electronic cigarette.
Inflammatory Blood-Based Biomarkers
Post-vaping inflammation monitored by changes in an integrated cluster of blood-based biomarkers from serum/plasma of non-smoking healthy participants quantified at 0 and 120 min post-inhalation. The cluster consisted of: CRP, sICAM-1 in serum and HMGB1, ASC in plasma assayed using ELISA and quantified using absorbance-concentration curves generated by the manufacturers' standards; nitric oxide metabolites (nitrate + nitrite, NOx) in serum assayed with a nitrate/nitrite kit using a colorimetric standard provided by the manufacturer; reactive oxygen species (ROS) was quantified by using immortalized human pulmonary microvascular endothelial cells plated, prepared with serum, labeled with ROS dye and imaged confocal fluorescence microscopy. The outcome measure was expressed as fold increase over pre-vaping values.
Time frame: Participant blood draws occurred at two time points: 1) pre-vaping, 2) 120 minutes post-vaping. Inflammation index is calculated from the fold change in biomarker values over pre-vaping values
Acute Change in Aortic Pulse Wave Velocity Post-vaping
Central arterial stiffness was assessed using aortic pulse-wave velocity (PWV), a biomarker of aortic stiffness calculated by measuring the velocity of a pulse wave between two points in the same artery. A higher aortic pulse wave velocity equates to a stiffer aorta. In each participant, aortic PWV was quantified, pre- and post-vaping, by dividing the path length of the aortic arch determined from a oblique sagittal image, by the transit time of the pulse pressure wave. Measurements obtained pre-vaping were compared to those obtained post-vaping.
Time frame: PWV calculation occurred at two time points: 1) pre-vaping, 2) Fifteen minutes post-vaping.
Change in Femoral Artery Flow-Mediated Dilation Post-Vaping
Degree of dilation (% change in cross-sectional area) of femoral artery during hyperemia (the transient increase in blood flow velocity) after e-cigarette vaping as compared to before e-cigarette vaping.
Time frame: Flow mediated dilation calculation occurred at two time points: 1) pre-vaping, 2) 40 minutes post-vaping.
Change in Washout Time Post-Vaping
Transit time of desaturated capillary blood from tissue to the imaging location after e-cigarette vaping
Time frame: Washout time calculation occurred at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping
Change in Upslope Post-Vaping
Tissue oxygen resaturation rate after e-cigarette vaping.
Time frame: Upslope was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping
Change in Overshoot Post-Vaping
Degree of overcompensatory effect post-vaping in the supply of oxygen after ischemia.
Time frame: Overshoot was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping.
Change in Breath Hold Index Post-Vaping
Rate of increase in blood flow velocity in the superior sagittal sinus from intermittent volitional apnea.
Time frame: Breath hold index was calculated at two time points: 1) pre-vaping, 2) five minutes post-vaping.
| Milestone | Healthy, Non-Smokers |
|---|---|
| Started | 31 |
| Completed | 31 |
| Not completed | 0 |
Post-vaping inflammation monitored by changes in an integrated cluster of blood-based biomarkers from serum/plasma of non-smoking healthy participants quantified at 0 and 120 min post-inhalation. The cluster consisted of: CRP, sICAM-1 in serum and HMGB1, ASC in plasma assayed using ELISA and quantified using absorbance-concentration curves generated by the manufacturers' standards; nitric oxide metabolites (nitrate + nitrite, NOx) in serum assayed with a nitrate/nitrite kit using a colorimetric standard provided by the manufacturer; reactive oxygen species (ROS) was quantified by using immortalized human pulmonary microvascular endothelial cells plated, prepared with serum, labeled with ROS dye and imaged confocal fluorescence microscopy. The outcome measure was expressed as fold increase over pre-vaping values.
| fold change | Healthy, Non-Smokers |
|---|---|
| Inflammatory Blood-Based Biomarkers | 5 ± 0.5 |
Central arterial stiffness was assessed using aortic pulse-wave velocity (PWV), a biomarker of aortic stiffness calculated by measuring the velocity of a pulse wave between two points in the same artery. A higher aortic pulse wave velocity equates to a stiffer aorta. In each participant, aortic PWV was quantified, pre- and post-vaping, by dividing the path length of the aortic arch determined from a oblique sagittal image, by the transit time of the pulse pressure wave. Measurements obtained pre-vaping were compared to those obtained post-vaping.
| Meters per second | Healthy, Non-Smokers |
|---|---|
| Acute Change in Aortic Pulse Wave Velocity Post-vaping | 0.19 ± 0.20 |
Degree of dilation (% change in cross-sectional area) of femoral artery during hyperemia (the transient increase in blood flow velocity) after e-cigarette vaping as compared to before e-cigarette vaping.
| percentage of change in cross-sectional | Healthy, Non-Smokers |
|---|---|
| Change in Femoral Artery Flow-Mediated Dilation Post-Vaping | -3.20 ± 0.90 |
Transit time of desaturated capillary blood from tissue to the imaging location after e-cigarette vaping
| Seconds | Healthy, Non-Smokers |
|---|---|
| Change in Washout Time Post-Vaping | -1.50 ± 0.30 |
Tissue oxygen resaturation rate after e-cigarette vaping.
| percentage of oxygen saturation/sec | Healthy, Non-Smokers |
|---|---|
| Change in Upslope Post-Vaping | 0 ± 0.20 |
Degree of overcompensatory effect post-vaping in the supply of oxygen after ischemia.
| percentage of oxygen saturation/sec | Healthy, Non-Smokers |
|---|---|
| Change in Overshoot Post-Vaping | 10 ± 2.0 |
Rate of increase in blood flow velocity in the superior sagittal sinus from intermittent volitional apnea.
| Centimeters per Seconds Squared | Healthy, Non-Smokers |
|---|---|
| Change in Breath Hold Index Post-Vaping | -0.02 ± 0.02 |
Collected over Six Hours.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy, Non-Smokers | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
Pre-intervention status (i.e. pre-vaping).
| Age, Categorical(Participants) | Healthy, Non-Smokers |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 31 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Healthy, Non-Smokers |
|---|---|
| Female | 14 |
| Male | 17 |
| Ethnicity (NIH/OMB)(Participants) | Healthy, Non-Smokers |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 29 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Healthy, Non-Smokers |
|---|---|
| United States | 31 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Aug 2022, 51 months.
Results were first posted in May 2024, 1 year 8 months after primary completion.
Of 63 non-industry phase 1 interventional studies under Inflammation, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's 51 months is above that.
Counting every sponsor, half of 82 studies reached it within 21 months; a quarter within 10 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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