Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-02-26 @ 12:36 AM
Study NCT ID:
NCT03616002
Status:
TERMINATED
Last Update Posted:
2021-02-04
First Post:
2015-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Hookah (Waterpipe) Smoking on Blood Vessel Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073867', 'term': 'Water Pipe Smoking'}], 'ancestors': [{'id': 'D000073868', 'term': 'Pipe Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000075387', 'term': 'Smoking Water Pipes'}], 'ancestors': [{'id': 'D000074604', 'term': 'Smoking Pipes'}, {'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'whyStopped': 'Due tot he Pandemic we decided to terminate this project.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2015-01-13', 'studyFirstSubmitQcDate': '2018-08-02', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pulse wave velocity', 'timeFrame': 'change from baseline to immediately after smoking'}, {'measure': 'aortic pressure waveform', 'timeFrame': 'change from baseline to immediately after smoking'}], 'primaryOutcomes': [{'measure': 'Brachial artery flow-mediated dilation', 'timeFrame': 'change from baseline to immediately after smoking'}], 'secondaryOutcomes': [{'measure': 'Reactive hyperemia peripheral arterial tonometry', 'timeFrame': 'change from baseline to immediately after smoking'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hookah Smoking']}, 'referencesModule': {'references': [{'pmid': '30764644', 'type': 'DERIVED', 'citation': 'Rezk-Hanna M, Mosenifar Z, Benowitz NL, Rader F, Rashid M, Davoren K, Moy NB, Doering L, Robbins W, Sarna L, Li N, Chang LC, Elashoff RM, Victor RG. High Carbon Monoxide Levels from Charcoal Combustion Mask Acute Endothelial Dysfunction Induced by Hookah (Waterpipe) Smoking in Young Adults. Circulation. 2019 May 7;139(19):2215-2224. doi: 10.1161/CIRCULATIONAHA.118.037375.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the acute effects of Hookah (waterpipe) smoking on blood vessel function. Hookah smoking has been shown to immediately increase blood pressure and heart rate which could result in damage in the inner lining of the body's blood vessels.", 'detailedDescription': 'The investigators will measure acute endothelial and vascular changes before and after a 30-minute Hookah smoking session in a controlled laboratory environment to: (1) Determine the acute effects of Hookah smoking on large-vessel endothelial vasodilator function measured by brachial artery flow mediated dilation; (2) Determine the acute effects of Hookah smoking on micro-vessel endothelial function as measured by reactive hyperemia peripheral arterial tonometry; (3) Determine the acute effects of Hookah smoking on pulse wave velocity and aortic pressure waveform measured by pulse tonometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 29 years of age\n* Habitual Hookah smoker defined as having smoked Hookah \\>=12 times in the past 12 months\n* Have not smoked cigarettes within the past 12 months\n\nExclusion Criteria:\n\n* History of cardiopulmonary, diabetes, dyslipidemia or psychiatric disease\n* Exhaled carbon monoxide level \\>10 ppm\n* BP \\< 140/90 mmHg\n* BMI \\<18.5 or \\> 30 kg•m2\n* Resting heart rate \\> 100 beats/min\n* Taking prescription medication\n* History of illicit drug use\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT03616002', 'briefTitle': 'Effects of Hookah (Waterpipe) Smoking on Blood Vessel Function', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Effects of Hookah Smoking on Vascular Regulation: Novel Insight Into Endothelial Function', 'orgStudyIdInfo': {'id': 'Pro00036547'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hookah smoking', 'description': 'Healthy habitual Hookah smokers will undergo brachial artery flow mediated dilation, reactive hyperemia peripheral arterial tonometry or pulse tonometry before and after Hookah smoking.', 'interventionNames': ['Other: Hookah smoking']}], 'interventions': [{'name': 'Hookah smoking', 'type': 'OTHER', 'description': 'ad lib hookah smoking for 30 minutes in a controlled laboratory environment.', 'armGroupLabels': ['Hookah smoking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Florian Rader, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Los Angeles', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D, M.Sc.', 'investigatorFullName': 'Florian Rader', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}