Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT03479203
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2018-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Acute Effects of E-Cigarette Aerosol Inhalation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'felix.wehrli@pennmedicine.upenn.edu', 'phone': '215-662-7951', 'title': 'Felix W.Wehrli, PhD', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Six Hours.', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy, Non-Smokers', 'description': 'Non-nicotinized electronic cigarette aerosol (16 2-second long puffs)\n\nElectronic Cigarette Aerosol: 16 two-second-long puffs from a non-nicotinized electronic cigarette.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Inflammatory Blood-Based Biomarkers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy, Non-Smokers', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.96', 'ciLowerLimit': '1', 'ciUpperLimit': '6', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.5', 'groupDescription': 'Blood assessed for C-reactive protein (CRP), soluble intercellular adhesion molecule (sICAM), the high mobility group box-1 (HMGB1), the NLRP3 inflammasome, and nitrates (NOx for nitric oxide) pre- and post-vaping. CRP, sICAM HMGB1 and NLRP3 is in ng/ml blood and NOx is in nanomol/ml. These numbers were weighted to obtain an "inflammation index" in blood. This index represents the fold increase over pre-vaping values.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'T-Test followed by Bonferroni post-hoc analysis.'}], 'paramType': 'MEAN', 'timeFrame': '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', 'description': "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.\n\nThe outcome measure was expressed as fold increase over pre-vaping values.", 'unitOfMeasure': 'fold change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Acute Change in Aortic Pulse Wave Velocity Post-vaping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy, Non-Smokers', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'spread': '0.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'PWV calculation occurred at two time points: 1) pre-vaping, 2) Fifteen minutes post-vaping.', 'description': '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.\n\nIn 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.', 'unitOfMeasure': 'Meters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.\n\n\\*One participant not analyzed due to discomfort during the scan.'}, {'type': 'PRIMARY', 'title': 'Change in Femoral Artery Flow-Mediated Dilation Post-Vaping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy, Non-Smokers', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.20', 'spread': '0.90', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Flow mediated dilation calculation occurred at two time points: 1) pre-vaping, 2) 40 minutes post-vaping.', 'description': '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.', 'unitOfMeasure': 'percentage of change in cross-sectional', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.\n\n\\*One participant not analyzed due to discomfort during the scan.'}, {'type': 'PRIMARY', 'title': 'Change in Washout Time Post-Vaping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy, Non-Smokers', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.50', 'spread': '0.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Washout time calculation occurred at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping', 'description': 'Transit time of desaturated capillary blood from tissue to the imaging location after e-cigarette vaping', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.)'}, {'type': 'PRIMARY', 'title': 'Change in Upslope Post-Vaping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy, Non-Smokers', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Upslope was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping', 'description': 'Tissue oxygen resaturation rate after e-cigarette vaping.', 'unitOfMeasure': 'percentage of oxygen saturation/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.)'}, {'type': 'PRIMARY', 'title': 'Change in Overshoot Post-Vaping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy, Non-Smokers', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Overshoot was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping.', 'description': 'Degree of overcompensatory effect post-vaping in the supply of oxygen after ischemia.', 'unitOfMeasure': 'percentage of oxygen saturation/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.)'}, {'type': 'PRIMARY', 'title': 'Change in Breath Hold Index Post-Vaping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy, Non-Smokers', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Breath hold index was calculated at two time points: 1) pre-vaping, 2) five minutes post-vaping.', 'description': 'Rate of increase in blood flow velocity in the superior sagittal sinus from intermittent volitional apnea.', 'unitOfMeasure': 'Centimeters per Seconds Squared', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy, Non-Smokers', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy, Non-Smokers', 'description': '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.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Information collected via self-reporting.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Pre-intervention status (i.e. pre-vaping).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-15', 'size': 118454, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-03T01:36', 'hasProtocol': True}, {'date': '2021-08-11', 'size': 286600, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-10-03T01:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2018-02-28', 'resultsFirstSubmitDate': '2023-08-14', 'studyFirstSubmitQcDate': '2018-03-23', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-15', 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammatory Blood-Based Biomarkers', 'timeFrame': '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', 'description': "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.\n\nThe outcome measure was expressed as fold increase over pre-vaping values."}, {'measure': 'Acute Change in Aortic Pulse Wave Velocity Post-vaping', 'timeFrame': 'PWV calculation occurred at two time points: 1) pre-vaping, 2) Fifteen minutes post-vaping.', 'description': '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.\n\nIn 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.'}, {'measure': 'Change in Femoral Artery Flow-Mediated Dilation Post-Vaping', 'timeFrame': 'Flow mediated dilation calculation occurred at two time points: 1) pre-vaping, 2) 40 minutes post-vaping.', 'description': '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.'}, {'measure': 'Change in Washout Time Post-Vaping', 'timeFrame': 'Washout time calculation occurred at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping', 'description': 'Transit time of desaturated capillary blood from tissue to the imaging location after e-cigarette vaping'}, {'measure': 'Change in Upslope Post-Vaping', 'timeFrame': 'Upslope was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping', 'description': 'Tissue oxygen resaturation rate after e-cigarette vaping.'}, {'measure': 'Change in Overshoot Post-Vaping', 'timeFrame': 'Overshoot was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping.', 'description': 'Degree of overcompensatory effect post-vaping in the supply of oxygen after ischemia.'}, {'measure': 'Change in Breath Hold Index Post-Vaping', 'timeFrame': 'Breath hold index was calculated at two time points: 1) pre-vaping, 2) five minutes post-vaping.', 'description': 'Rate of increase in blood flow velocity in the superior sagittal sinus from intermittent volitional apnea.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inflammation'], 'conditions': ['Endothelial Dysfunction', 'Biochemical Markers']}, 'referencesModule': {'references': [{'pmid': '33991175', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '32841482', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31990264', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33216614', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '32528311', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '31429679', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '31042077', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '32538283', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• BMI of 18.5 - 30\n\nExclusion Criteria:\n\n* Cancer\n* HIV\n* Mental illness\n* Overt cardio- or neurovascular disease (prior heart attack, stroke, transient ischemic attacks)\n* Serious arrhythmias\n* Bronchospastic disease\n* Upper respiratory tract infection within the past six weeks\n* Chronic medication or antibiotics\n* Claustrophobia / contraindications for MRI'}, 'identificationModule': {'nctId': 'NCT03479203', 'briefTitle': 'Acute Effects of E-Cigarette Aerosol Inhalation', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Acute and Long-term Effects of E-Cigarette Aerosol Inhalation on Biomarkers of Endothelial Function and Vascular Reactivity', 'orgStudyIdInfo': {'id': '828195'}, 'secondaryIdInfos': [{'id': 'R01HL139358', 'link': 'https://reporter.nih.gov/quickSearch/R01HL139358', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy, Non-Smokers', 'description': 'Non-nicotinized electronic cigarette aerosol (16 2-second long puffs)', 'interventionNames': ['Drug: Electronic Cigarette Aerosol']}], 'interventions': [{'name': 'Electronic Cigarette Aerosol', 'type': 'DRUG', 'description': '16 two-second-long puffs from a non-nicotinized electronic cigarette.', 'armGroupLabels': ['Healthy, Non-Smokers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Perelman School of Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Felix W. Wehrli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiologic Science, Biochemistry and Biophysics', 'investigatorFullName': 'Felix W. Wehrli', 'investigatorAffiliation': 'University of Pennsylvania'}}}}