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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL139358 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy, Non-Smokers | Experimental | Non-nicotinized electronic cigarette aerosol (16 2-second long puffs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Cigarette Aerosol | Drug | 16 two-second-long puffs from a non-nicotinized electronic cigarette. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Flow mediated dilation calculation occurred at two time points: 1) pre-vaping, 2) 40 minutes post-vaping. |
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Inclusion Criteria:
• BMI of 18.5 - 30
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felix W. Wehrli, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Perelman School of Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33991175 | Background | Zamani P, Proto EA, Wilson N, Fazelinia H, Ding H, Spruce LA, Davila A Jr, Hanff TC, Mazurek JA, Prenner SB, Desjardins B, Margulies KB, Kelly DP, Arany Z, Doulias PT, Elrod JW, Allen ME, McCormack SE, Schur GM, D'Aquilla K, Kumar D, Thakuri D, Prabhakaran K, Langham MC, Poole DC, Seeholzer SH, Reddy R, Ischiropoulos H, Chirinos JA. Multimodality assessment of heart failure with preserved ejection fraction skeletal muscle reveals differences in the machinery of energy fuel metabolism. ESC Heart Fail. 2021 Aug;8(4):2698-2712. doi: 10.1002/ehf2.13329. Epub 2021 May 15. | |
| 32841482 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy, Non-Smokers | Men and women between the ages of 18 and 35 years with no history of smoking, systemic disease, recent respiratory infection or chronic intake of medication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Pre-intervention status (i.e. pre-vaping).
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy, Non-Smokers | Men and women between the ages of 18 and 35 years with no history of smoking, systemic disease, recent respiratory infection or chronic intake of medication. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | For each participant, the fold change is obtained as as logarithmic fold increases over pre-vaping values, as: log2(fold change) = log2(expression value(s) of post-vape biomarker) - log2(expression value(s) of pre-vape biomarker). Data are expressed as means ± SD (5 - 18 nanograms per milliliter range) and two-tailed paired t tests were used to determine statistical significance. | Posted | Mean | Standard Deviation | fold change | 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 |
Six Hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy, Non-Smokers | Non-nicotinized electronic cigarette aerosol (16 2-second long puffs) Electronic Cigarette Aerosol: 16 two-second-long puffs from a non-nicotinized electronic cigarette. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Felix W.Wehrli, PhD | University of Pennsylvania | 215-662-7951 | felix.wehrli@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2017 | Oct 3, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 11, 2021 | Oct 3, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Change in Washout Time Post-Vaping |
Transit time of desaturated capillary blood from tissue to the imaging location after e-cigarette vaping |
| 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. | 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. | 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. | Breath hold index was calculated at two time points: 1) pre-vaping, 2) five minutes post-vaping. |
| Background |
| Langham MC, Caporale AS, Wehrli FW, Parry S, Schwartz N. Evaluation of Vascular Reactivity of Maternal Vascular Adaptations of Pregnancy With Quantitative MRI: Pilot Study. J Magn Reson Imaging. 2021 Feb;53(2):447-455. doi: 10.1002/jmri.27342. Epub 2020 Aug 25. |
| 31990264 | Background | Kligerman S, Raptis C, Larsen B, Henry TS, Caporale A, Tazelaar H, Schiebler ML, Wehrli FW, Klein JS, Kanne J. Radiologic, Pathologic, Clinical, and Physiologic Findings of Electronic Cigarette or Vaping Product Use-associated Lung Injury (EVALI): Evolving Knowledge and Remaining Questions. Radiology. 2020 Mar;294(3):491-505. doi: 10.1148/radiol.2020192585. Epub 2020 Jan 28. |
| 33216614 | Result | Chatterjee S, Caporale A, Tao JQ, Guo W, Johncola A, Strasser AA, Leone FT, Langham MC, Wehrli FW. Acute e-cig inhalation impacts vascular health: a study in smoking naive subjects. Am J Physiol Heart Circ Physiol. 2021 Jan 1;320(1):H144-H158. doi: 10.1152/ajpheart.00628.2020. Epub 2020 Nov 20. |
| 32528311 | Result | Wehrli FW, Caporale A, Langham MC, Chatterjee S. New Insights From MRI and Cell Biology Into the Acute Vascular-Metabolic Implications of Electronic Cigarette Vaping. Front Physiol. 2020 May 21;11:492. doi: 10.3389/fphys.2020.00492. eCollection 2020. |
| 31429679 | Result | Caporale A, Langham MC, Guo W, Johncola A, Chatterjee S, Wehrli FW. Acute Effects of Electronic Cigarette Aerosol Inhalation on Vascular Function Detected at Quantitative MRI. Radiology. 2019 Oct;293(1):97-106. doi: 10.1148/radiol.2019190562. Epub 2019 Aug 20. |
| 31042077 | Result | Chatterjee S, Tao JQ, Johncola A, Guo W, Caporale A, Langham MC, Wehrli FW. Acute exposure to e-cigarettes causes inflammation and pulmonary endothelial oxidative stress in nonsmoking, healthy young subjects. Am J Physiol Lung Cell Mol Physiol. 2019 Aug 1;317(2):L155-L166. doi: 10.1152/ajplung.00110.2019. Epub 2019 May 1. |
| 32538283 | Result | Caporale A, Lee H, Lei H, Rao H, Langham MC, Detre JA, Wu PH, Wehrli FW. Cerebral metabolic rate of oxygen during transition from wakefulness to sleep measured with high temporal resolution OxFlow MRI with concurrent EEG. J Cereb Blood Flow Metab. 2021 Apr;41(4):780-792. doi: 10.1177/0271678X20919287. Epub 2020 Jun 14. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Information collected via self-reporting. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | Participants* underwent an intervention which consisted of 16 3-second inhalations from a vaping device delivering non-nicotinized electronic cigarette aerosol. A quantitative magnetic resonance imaging scan was conducted pre- and post-vaping. Differences in aortic PWV before versus after e-cigarette vaping were assessed. *One participant not analyzed due to discomfort during the scan. | Posted | Mean | Standard Deviation | Meters per second | PWV calculation occurred at two time points: 1) pre-vaping, 2) Fifteen minutes post-vaping. |
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| Primary | 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. | Participants* underwent an intervention which consisted of 16 3-second inhalations from a vaping device delivering non-nicotinized electronic cigarette aerosol. A quantitative magnetic resonance imaging scan was conducted pre- and post-vaping. Differences in flow mediated dilation before versus after e-cigarette vaping were assessed. *One participant not analyzed due to discomfort during the scan. | Posted | Mean | Standard Deviation | percentage of change in cross-sectional | Flow mediated dilation calculation occurred at two time points: 1) pre-vaping, 2) 40 minutes post-vaping. |
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| Primary | Change in Washout Time Post-Vaping | Transit time of desaturated capillary blood from tissue to the imaging location after e-cigarette vaping | Participants underwent an intervention which consisted of 16 3-second inhalations from a vaping device delivering non-nicotinized electronic cigarette aerosol. A 50 minute quantitative magnetic resonance imaging protocol was conducted pre- and immediately post-vaping. (One participant not analyzed due discomfort with the cuff occlusion portion of the protocol.) | Posted | Mean | Standard Deviation | Seconds | Washout time calculation occurred at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping |
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| Primary | Change in Upslope Post-Vaping | Tissue oxygen resaturation rate after e-cigarette vaping. | Participants underwent an intervention which consisted of 16 3-second inhalations from a vaping device delivering non-nicotinized electronic cigarette aerosol. A 50 minute quantitative magnetic resonance imaging protocol was conducted pre- and immediately post-vaping. (One participant not analyzed due discomfort with the cuff occlusion portion of the protocol.) | Posted | Mean | Standard Deviation | percentage of oxygen saturation/sec | Upslope was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping |
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| Primary | Change in Overshoot Post-Vaping | Degree of overcompensatory effect post-vaping in the supply of oxygen after ischemia. | Participants underwent an intervention which consisted of 16 3-second inhalations from a vaping device delivering non-nicotinized electronic cigarette aerosol. A 50 minute quantitative magnetic resonance imaging protocol was conducted pre- and immediately post-vaping. (One participant not analyzed due discomfort with the cuff occlusion portion of the protocol.) | Posted | Mean | Standard Deviation | percentage of oxygen saturation/sec | Overshoot was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping. |
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| Primary | Change in Breath Hold Index Post-Vaping | Rate of increase in blood flow velocity in the superior sagittal sinus from intermittent volitional apnea. | Participants underwent an intervention which consisted of 16 3-second inhalations from a vaping device delivering non-nicotinized electronic cigarette aerosol. A 50 minute quantitative magnetic resonance imaging protocol was conducted pre- and post-vaping. (One participant not analyzed due discomfort with the cuff occlusion portion of the protocol.) | Posted | Mean | Standard Deviation | Centimeters per Seconds Squared | Breath hold index was calculated at two time points: 1) pre-vaping, 2) five minutes post-vaping. |
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