Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-02-22 @ 5:54 AM
Study NCT ID:
NCT03690427
Status:
COMPLETED
Last Update Posted:
2023-08-16
First Post:
2018-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Cardiovascular Effects of Electronic Hookah Vaping
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': 'mrhanna@mednet.ucla.edu', 'phone': '3102068654', 'title': 'Mary Rezk-Hanna, PhD', 'organization': 'University of California, Los Angeles'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Throughout the entire study duration (i.e., scheduled study visit lasting 4-5 hours), including the 30-minute hookah smoking and e-hookah vaping exposure sessions.', 'eventGroups': [{'id': 'EG000', 'title': 'Traditional Hookah', 'description': 'Participants who were invited to smoke a 30-minute combustible charcoal-heated hookah-smoking session.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Electronic Hookah', 'description': 'Participants who were invited to vape a 30-minute electronic hookah bowl session.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Flow-Mediated Dilation (FMD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Hookah', 'description': 'Participants who completed a 30-minute e-hookah vaping session'}, {'id': 'OG001', 'title': 'Traditional Hookah', 'description': 'Participants who completed a 30-minute combustible hookah smoking session'}], 'classes': [{'title': 'FMD before exposure session', 'categories': [{'measurements': [{'value': '6.11', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '5.89', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': 'FMD after exposure session', 'categories': [{'measurements': [{'value': '4.79', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '7.31', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'Using ultrasound, FMD of the brachial artery induced by reactive hyperemia, was used to measure endothelium-dependent vasodilator function. Baseline diameter and velocity were recorded for 45 seconds and resumed 30 seconds before cuff deflation and continuously for 2 minutes after deflation to obtain true peak vasodilatory response.', 'unitOfMeasure': 'percentage of arterial diameter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants who completed study visits (1 participant had suboptimal ultrasound images from the e-hookah group; and 2 did not have images from the traditional hookah group)'}, {'type': 'PRIMARY', 'title': 'Carotid-Femoral Pulse Wave Velocity (Cf-PWV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Hookah', 'description': 'Participants who completed a 30-minute e-hookah vaping session'}, {'id': 'OG001', 'title': 'Traditional Hookah', 'description': 'Participants who completed a 30-minute combustible hookah smoking session'}], 'classes': [{'title': 'cf-PWV before exposure session', 'categories': [{'measurements': [{'value': '8.20', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '8.15', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'cf-PWV after exposure session', 'categories': [{'measurements': [{'value': '8.94', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '8.71', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'Using applanation tonometry, cf-PWV was used to measure central arterial stiffness.', 'unitOfMeasure': 'm/sec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants who completed study visits (unable to obtain data on 4 participants in the e-hookah group)'}, {'type': 'PRIMARY', 'title': 'HDL Oxidant Index (HOI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Hookah', 'description': 'Participants who completed a 30-minute e-hookah vaping session'}, {'id': 'OG001', 'title': 'Traditional Hookah', 'description': 'Participants who completed a 30-minute combustible hookah smoking session'}], 'classes': [{'title': 'HOI before exposure session', 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'HOI after exposure session', 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'Capacity was determined as the ability of HDL to inhibit LDL-induced oxidation of dihydrodichlorofluorescein into the fluorescent dichlorofluorescein. Capacity was expressed as an HDL oxidative index, determined by the ratio of dichlorofluorescein fluorescence in the presence and absence of HDL. An index of \\< 1.0 denotes protective antioxidant HDL, whereas an index of \\> 1.0 indicates pro-oxidant HDL.', 'unitOfMeasure': 'index', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants who completed study visits (unable to obtain data on 4 participants in the e-hookah group)'}, {'type': 'PRIMARY', 'title': 'Paraoxonase-1 (PON-1) Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Hookah', 'description': 'Participants who completed a 30-minute e-hookah vaping session'}, {'id': 'OG001', 'title': 'Traditional Hookah', 'description': 'Participants who completed a 30-minute combustible hookah smoking session'}], 'classes': [{'title': 'PON-1 before exposure session', 'categories': [{'measurements': [{'value': '1071.24', 'spread': '188.79', 'groupId': 'OG000'}, {'value': '709.32', 'spread': '112.43', 'groupId': 'OG001'}]}]}, {'title': 'PON-1 after exposure session', 'categories': [{'measurements': [{'value': '1151.73', 'spread': '207.98', 'groupId': 'OG000'}, {'value': '701.29', 'spread': '110.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'PON-1 activity was determined by the ability of PON-1, associated with HDL, to hydrolyze paraoxon substrate. The hydrolysis of paraoxon (diethyl-p-nitrophenyl phosphate) to p-nitrophenol by PON-1 was determined by incubating 5 mL of plasma with 1.0 mM paraoxon in 100 mM tris-HCl buffer (pH, 8.5).\n\nUnit of Measure: expressed as micromoles of p-nitrophenol formed per minute for every 1 mL plasma.', 'unitOfMeasure': 'units/mL:see Outcome Measure Description', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants who completed study visits (unable to obtain data on 4 participants in the e-hookah group)'}, {'type': 'PRIMARY', 'title': 'Arylesterase Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Hookah', 'description': 'Participants who completed a 30-minute e-hookah vaping session'}, {'id': 'OG001', 'title': 'Traditional Hookah', 'description': 'Participants who completed a 30-minute combustible hookah smoking session'}], 'classes': [{'title': 'Arylesterase activity before exposure session', 'categories': [{'measurements': [{'value': '277.36', 'spread': '14.26', 'groupId': 'OG000'}, {'value': '281.38', 'spread': '19.33', 'groupId': 'OG001'}]}]}, {'title': 'Arylesterase activity after exposure session', 'categories': [{'measurements': [{'value': '295.78', 'spread': '16.78', 'groupId': 'OG000'}, {'value': '285.06', 'spread': '16.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions.', 'description': 'Arylesterase activity (lipid peroxidation biomarker) was determined by the rate of hydrolysis of phenyl acetate to phenol. Briefly, 4 mL plasma was incubated with 3.5 mM phenyl acetate in 9 mM Tris-HCl buffer (pH, 8.0) containing 0.9 mM CaCl2 at RT. The kinetics of phenol formation were determined by recording the absorbance at 270 nm every 15 s for 2 min.\n\nUnit of Measure: nanomoles of product formed per minute per milliliter of plasma.', 'unitOfMeasure': 'units/mL:see Outcome Measure Description', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants who completed study visits (unable to obtain data on 1 participant from the e-hookah group and 3 participants from the traditional hookah group).'}, {'type': 'PRIMARY', 'title': 'High-sensitivity C-reactive Protein (Hs-CRP) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Hookah', 'description': 'Participants who completed a 30-minute e-hookah vaping session'}, {'id': 'OG001', 'title': 'Traditional Hookah', 'description': 'Participants who completed a 30-minute combustible hookah smoking session'}], 'classes': [{'title': 'hs-CRP before exposure session', 'categories': [{'measurements': [{'value': '0.72', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'hs-CRP after exposure session', 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'Plasma hs-CRP (inflammatory biomarker)', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants who completed study visits (unable to obtain data on 2 participants in the traditional hookah group)'}, {'type': 'PRIMARY', 'title': 'Tumor Necrosis Factor-α (TNFα) Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Hookah', 'description': 'Participants who completed a 30-minute e-hookah vaping session'}, {'id': 'OG001', 'title': 'Traditional Hookah', 'description': 'Participants who completed a 30-minute combustible hookah smoking session'}], 'classes': [{'title': 'TNFα before exposure session', 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'TNFα after exposure session', 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'Plasma TNFα (inflammatory biomarker)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants who completed study visits (unable to obtain data on 1 participant in the e-hookah group)'}, {'type': 'SECONDARY', 'title': 'Flow-Mediated Dilation (FMD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Hookah', 'description': 'Assess the acute effects of e-hookah vaping on FMD before and after intravenous administration of a supra-physiological dose of ascorbic acid.'}], 'classes': [{'title': 'FMD before e-hookah vaping', 'categories': [{'measurements': [{'value': '9.46', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'FMD after e-hookah vaping', 'categories': [{'measurements': [{'value': '8.74', 'spread': '0.84', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Effect of FMD with e-hookah vaping examined after pretreatment of intravenous infusion of antioxidant ascorbic acid (administered over 60 minutes at 0.5 mL min-1)', 'description': 'Using ultrasound, FMD of the brachial artery, induced by reactive hyperemia, was used to measure endothelium-dependent vasodilator function after intravenous infusion of antioxidant ascorbic acid. Infusion of antioxidant ascorbic acid was done before the e-hookah vaping session.', 'unitOfMeasure': 'percentage of arterial diameter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of participants, who completed the e-hookah vaping protocol.'}, {'type': 'SECONDARY', 'title': 'Endothelium-independent Vasodilator Function (Control Test for Endothelium-dependent Vasodilator Function)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Hookah', 'description': 'Participants who completed a 30-minute e-hookah vaping session'}], 'classes': [{'title': 'Dilation before e-hookah vaping', 'categories': [{'measurements': [{'value': '27.15', 'spread': '1.98', 'groupId': 'OG000'}]}]}, {'title': 'Dilation after e-hookah vaping', 'categories': [{'measurements': [{'value': '25.17', 'spread': '1.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and post- sublingual administration of nitroglycerin (0.15 mg), which was administrated before and after e-hookah vaping.', 'description': 'As a control test for the assessment of endothelium-dependent vasodilator function, using ultrasound the brachial artery, endothelium-independent dilatation was assessed by administering sublingual nitroglycerin. This measure was assessed 10 minutes after FMD testing. Ultrasound images were recorded continuously for a total of 10 minutes', 'unitOfMeasure': 'percentage of arterial diameter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of participants, who completed the e-hookah vaping protocol.'}, {'type': 'SECONDARY', 'title': 'Augmentation Index (AI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Hookah', 'description': 'Participants who completed a 30-minute e-hookah vaping session'}, {'id': 'OG001', 'title': 'Traditional Hookah', 'description': 'Participants who completed a 30-minute combustible hookah smoking session'}], 'classes': [{'title': 'AI before exposure session', 'categories': [{'measurements': [{'value': '7.97', 'spread': '2.97', 'groupId': 'OG000'}, {'value': '7.79', 'spread': '2.54', 'groupId': 'OG001'}]}]}, {'title': 'AI after exposure session', 'categories': [{'measurements': [{'value': '13.55', 'spread': '3.24', 'groupId': 'OG000'}, {'value': '10.66', 'spread': '2.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'AI was used to measure central stiffness. It was calculated as the ratio of augmentation pressure (difference between the second and first systolic peaks of the aortic pressure waveform) and pulse pressure expressed as a percentage.', 'unitOfMeasure': 'percentage of the pulse pressure', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants who completed study visits (unable to obtain data on 4 participants in the e-hookah group and 1 in the traditional hookah group)'}, {'type': 'SECONDARY', 'title': 'Interleukin 6 (IL-6) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Hookah', 'description': 'Participants who completed a 30-minute e-hookah vaping session'}, {'id': 'OG001', 'title': 'Traditional Hookah', 'description': 'Participants who completed a 30-minute combustible hookah smoking session'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'A change between two points is reported below (e.g., value at post-exposure session minus value at pre-exposure session).', 'description': 'Plasma IL-6 (inflammatory biomarker).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants who completed study visits (unable to obtain data on 5 participants in the e-hookah group)'}, {'type': 'SECONDARY', 'title': 'Interleukin 10 (IL-10) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Hookah', 'description': 'Participants who completed a 30-minute e-hookah vaping session'}, {'id': 'OG001', 'title': 'Traditional Hookah', 'description': 'Participants who completed a 30-minute combustible hookah smoking session'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'A change between two points is reported below (e.g., value at post-exposure session minus value at pre-exposure session).', 'description': 'Serum IL-10 (anti-inflammatory biomarker)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants who completed study visits (unable to obtain data on 5 participants in the e-hookah group)'}, {'type': 'SECONDARY', 'title': 'Nicotine Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Hookah', 'description': 'Participants who completed a 30-minute e-hookah vaping session'}, {'id': 'OG001', 'title': 'Traditional Hookah', 'description': 'Participants who completed a 30-minute combustible hookah smoking session'}], 'classes': [{'title': 'Plasma nicotine before exposure session', 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Plasma nicotine after exposure session', 'categories': [{'measurements': [{'value': '5.83', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '6.96', 'spread': '1.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'Plasma nicotine levels (smoking or vaping exposure biomarker)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants who completed study visits (unable to obtain data on 1 participant in the e-hookah group and 1 participant in the traditional hookah group)'}, {'type': 'SECONDARY', 'title': 'Carbon Monoxide (CO) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Hookah', 'description': 'Participants who completed a 30-minute e-hookah vaping session'}, {'id': 'OG001', 'title': 'Traditional Hookah', 'description': 'Participants who completed a 30-minute combustible hookah smoking session'}], 'classes': [{'title': 'CO before exposure session', 'categories': [{'measurements': [{'value': '2.58', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '3.38', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'CO after exposure session', 'categories': [{'measurements': [{'value': '2.31', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '40.19', 'spread': '6.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'Exhaled CO levels (smoking or vaping exposure biomarker)', 'unitOfMeasure': 'ppm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants who completed study visits (unable to obtain data on 1 participant in the e-hookah group; and 1 participant in the traditional hookah group)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Traditional Followed by Electronic Hookah', 'description': 'Participants were invited to smoke a 30-minute traditional charcoal-heated hookah-smoking session, followed by a 30-minute electronic hookah vaping session.\n\nTo mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days.'}, {'id': 'FG001', 'title': 'Electronic Followed by Traditional Hookah', 'description': 'Participants were invited to vape a 30-minute electronic hookah session, followed by a 30-minute traditional charcoal-heated hookah smoking session.\n\nTo mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Requested by subject not to complete traditional hookah', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited through advertisements posted at Southern California colleges and universities, as well as social media websites, from December 2018 to August 2020.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Participants who were randomized to either smoke hookah first followed by vape hookah or vape hookah first followed by smoke hookah.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', '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': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', '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': '17', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-06', 'size': 161873, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-24T12:24', 'hasProtocol': True}, {'date': '2018-11-06', 'size': 140303, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-24T12:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Charcoal-heated hookah smoking vs. electronic hookah vaping'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-24', 'studyFirstSubmitDate': '2018-09-26', 'resultsFirstSubmitDate': '2023-05-27', 'studyFirstSubmitQcDate': '2018-09-27', 'lastUpdatePostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-24', 'studyFirstPostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow-Mediated Dilation (FMD)', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'Using ultrasound, FMD of the brachial artery induced by reactive hyperemia, was used to measure endothelium-dependent vasodilator function. Baseline diameter and velocity were recorded for 45 seconds and resumed 30 seconds before cuff deflation and continuously for 2 minutes after deflation to obtain true peak vasodilatory response.'}, {'measure': 'Carotid-Femoral Pulse Wave Velocity (Cf-PWV)', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'Using applanation tonometry, cf-PWV was used to measure central arterial stiffness.'}, {'measure': 'HDL Oxidant Index (HOI)', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'Capacity was determined as the ability of HDL to inhibit LDL-induced oxidation of dihydrodichlorofluorescein into the fluorescent dichlorofluorescein. Capacity was expressed as an HDL oxidative index, determined by the ratio of dichlorofluorescein fluorescence in the presence and absence of HDL. An index of \\< 1.0 denotes protective antioxidant HDL, whereas an index of \\> 1.0 indicates pro-oxidant HDL.'}, {'measure': 'Paraoxonase-1 (PON-1) Activity', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'PON-1 activity was determined by the ability of PON-1, associated with HDL, to hydrolyze paraoxon substrate. The hydrolysis of paraoxon (diethyl-p-nitrophenyl phosphate) to p-nitrophenol by PON-1 was determined by incubating 5 mL of plasma with 1.0 mM paraoxon in 100 mM tris-HCl buffer (pH, 8.5).\n\nUnit of Measure: expressed as micromoles of p-nitrophenol formed per minute for every 1 mL plasma.'}, {'measure': 'Arylesterase Activity', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions.', 'description': 'Arylesterase activity (lipid peroxidation biomarker) was determined by the rate of hydrolysis of phenyl acetate to phenol. Briefly, 4 mL plasma was incubated with 3.5 mM phenyl acetate in 9 mM Tris-HCl buffer (pH, 8.0) containing 0.9 mM CaCl2 at RT. The kinetics of phenol formation were determined by recording the absorbance at 270 nm every 15 s for 2 min.\n\nUnit of Measure: nanomoles of product formed per minute per milliliter of plasma.'}, {'measure': 'High-sensitivity C-reactive Protein (Hs-CRP) Levels', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'Plasma hs-CRP (inflammatory biomarker)'}, {'measure': 'Tumor Necrosis Factor-α (TNFα) Concentrations', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'Plasma TNFα (inflammatory biomarker)'}], 'secondaryOutcomes': [{'measure': 'Flow-Mediated Dilation (FMD)', 'timeFrame': 'Effect of FMD with e-hookah vaping examined after pretreatment of intravenous infusion of antioxidant ascorbic acid (administered over 60 minutes at 0.5 mL min-1)', 'description': 'Using ultrasound, FMD of the brachial artery, induced by reactive hyperemia, was used to measure endothelium-dependent vasodilator function after intravenous infusion of antioxidant ascorbic acid. Infusion of antioxidant ascorbic acid was done before the e-hookah vaping session.'}, {'measure': 'Endothelium-independent Vasodilator Function (Control Test for Endothelium-dependent Vasodilator Function)', 'timeFrame': 'Pre- and post- sublingual administration of nitroglycerin (0.15 mg), which was administrated before and after e-hookah vaping.', 'description': 'As a control test for the assessment of endothelium-dependent vasodilator function, using ultrasound the brachial artery, endothelium-independent dilatation was assessed by administering sublingual nitroglycerin. This measure was assessed 10 minutes after FMD testing. Ultrasound images were recorded continuously for a total of 10 minutes'}, {'measure': 'Augmentation Index (AI)', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'AI was used to measure central stiffness. It was calculated as the ratio of augmentation pressure (difference between the second and first systolic peaks of the aortic pressure waveform) and pulse pressure expressed as a percentage.'}, {'measure': 'Interleukin 6 (IL-6) Levels', 'timeFrame': 'A change between two points is reported below (e.g., value at post-exposure session minus value at pre-exposure session).', 'description': 'Plasma IL-6 (inflammatory biomarker).'}, {'measure': 'Interleukin 10 (IL-10) Levels', 'timeFrame': 'A change between two points is reported below (e.g., value at post-exposure session minus value at pre-exposure session).', 'description': 'Serum IL-10 (anti-inflammatory biomarker)'}, {'measure': 'Nicotine Levels', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'Plasma nicotine levels (smoking or vaping exposure biomarker)'}, {'measure': 'Carbon Monoxide (CO) Levels', 'timeFrame': 'Pre- and post- the 30-minute smoking or vaping exposure sessions', 'description': 'Exhaled CO levels (smoking or vaping exposure biomarker)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endothelial Dysfunction', 'Inflammation', 'Oxidative Stress']}, 'referencesModule': {'references': [{'pmid': '34298007', 'type': 'DERIVED', 'citation': 'Rezk-Hanna M, Gupta R, Nettle CO, Dobrin D, Cheng CW, Means A, Brecht ML, Tashkin DP, Araujo JA. Differential Effects of Electronic Hookah Vaping and Traditional Combustible Hookah Smoking on Oxidation, Inflammation, and Arterial Stiffness. Chest. 2022 Jan;161(1):208-218. doi: 10.1016/j.chest.2021.07.027. Epub 2021 Jul 21.'}, {'pmid': '33615833', 'type': 'DERIVED', 'citation': 'Rezk-Hanna M, Seals DR, Rossman MJ, Gupta R, Nettle CO, Means A, Dobrin D, Cheng CW, Brecht ML, Mosenifar Z, Araujo JA, Benowitz NL. Ascorbic Acid Prevents Vascular Endothelial Dysfunction Induced by Electronic Hookah (Waterpipe) Vaping. J Am Heart Assoc. 2021 Feb;10(5):e019271. doi: 10.1161/JAHA.120.019271. Epub 2021 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'Hookah (water-pipe) tobacco smoking has quickly grown to become a major global tobacco epidemic among youth; with electronic (e-) hookahs more recently increasing in popularity especially among young female adults, who endorse marketing claims that these products are a safer alternative to traditional hookah, but scientific evidence is lacking. The study aims to elucidate the comparative effects of traditional hookah smoking vs. e-hookah vaping on human vascular and endothelial function; and examine the role of inflammation and oxidative stress, as likely mechanisms in hookah-related cardiovascular disease pathogenesis.', 'detailedDescription': 'Hookah (water-pipe) tobacco smoking is rapidly increasing in popularity worldwide. Contributing to this popularity is the unsubstantiated belief that traditional charcoal-heated hookah smoke is detoxified as it passes through the water-filled basin. More recently, electronic (e-) hookahs-containing flavored e-liquid that is heated electrically but inhaled through traditional water-pipes-are increasing in popularity in the United States among young female adults, who endorse marketing claims that these products are even safer than traditional charcoal-heated hookah products. The objective of this project is to investigate the comparative effects of traditional charcoal-heated hookah smoking versus e-hookah vaping on endothelial and vascular function and their mechanistic role in the development of cardiovascular disease. The investigators will test the hypothesis that: 1) in the absence of burning charcoal briquettes and virtually any carbon monoxide (CO) exposure, e-hookah vaping acutely impairs endothelial function and evokes acute central arterial stiffness, opposite from the endothelial function augmentation observed after traditional charcoal-heated hookah smoking, which is likely mediated by the large CO boost emitted from burning charcoal briquettes used to heat the flavored hookah tobacco; and 2) the processes of oxidative stress and inflammation play a pivotal mechanistic role underlying these vascular changes. Accordingly, in a cross-over study comparing traditional hookah smoking to e-hookah vaping, the investigators will assess endothelial function measured by brachial artery flow-mediated dilation and aortic stiffness by pulse wave velocity and augmentation index in 18 young healthy hookah smokers 21-39 years old, before and after ad lib 30-minute smoking/ vaping exposure sessions. To test for oxidative stress mediation, the investigators will determine if any acute impairment in endothelial function after e-hookah can be prevented by intravenous Vitamin C infusion, a potent anti-oxidant. Inflammatory and oxidant biomarkers, as well as smoking exposure biomarkers will be collected before and after the exposure sessions. The results of this proposal: (a) stand to fill in gaps in our mechanistic understanding of the comparative effect of traditional vs. e-hookah bowl on vascular and endothelial function; and (b) help inform policy decisions by the FDA about regulation of hookah products.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 21-39 years old hookah smokers: smoked hookah \\>12x in last 12 months\n* no history of illicit drugs or marijuana\n* no evidence of cardiopulmonary disease by history/ physical\n* no diabetes: fasting blood glucose \\<100 mg/dl\n* BP\\<140/90mmHg\n* resting HR\\<100 bpm\n* BMI\\<30kg•m2\n* no prescription medication\n\nExclusion Criteria:\n\n* exhaled CO\\>10 ppm (smoking non-abstinence)\n* positive pregnancy test\n* psychiatric illness'}, 'identificationModule': {'nctId': 'NCT03690427', 'briefTitle': 'The Cardiovascular Effects of Electronic Hookah Vaping', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Investigating the Cardiovascular Toxicity of Exposure to Electronic Hookah Smoking', 'orgStudyIdInfo': {'id': '1R21HL145002-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21HL145002-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R21HL145002-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21HL145002-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Traditional Charcoal-Heated Hookah followed by Electronic Hookah', 'description': 'Participants were invited to smoke a 30-minute traditional charcoal-heated hookah-smoking session, followed by a 30-minute electronic hookah vaping session.\n\nTo mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days.', 'interventionNames': ['Other: Traditional hookah smoking', 'Other: Electronic hookah vaping']}, {'type': 'EXPERIMENTAL', 'label': 'Electronic followed by Traditional Charcoal-Heated Hookah', 'description': 'Participants were invited to vape a 30-minute electronic hookah session, followed by a 30-minute traditional charcoal-heated hookah smoking session.\n\nTo mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days.', 'interventionNames': ['Other: Traditional hookah smoking', 'Other: Electronic hookah vaping']}], 'interventions': [{'name': 'Traditional hookah smoking', 'type': 'OTHER', 'otherNames': ['Combustible hookah smoking'], 'description': 'Charcoal-heated hookah smoking', 'armGroupLabels': ['Electronic followed by Traditional Charcoal-Heated Hookah', 'Traditional Charcoal-Heated Hookah followed by Electronic Hookah']}, {'name': 'Electronic hookah vaping', 'type': 'OTHER', 'description': 'Electronic hookah bowl inhalation', 'armGroupLabels': ['Electronic followed by Traditional Charcoal-Heated Hookah', 'Traditional Charcoal-Heated Hookah followed by Electronic Hookah']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-8361', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', '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': 'Principal Investigator', 'investigatorFullName': 'Mary Rezk-Hanna, PhD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}