Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-05 @ 11:53 PM
Study NCT ID:
NCT01007760
Status:
COMPLETED
Last Update Posted:
2011-07-19
First Post:
2009-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-dependent Effects of Second-hand Smoke on Vascular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014028', 'term': 'Tobacco Smoke Pollution'}], 'ancestors': [{'id': 'D012906', 'term': 'Smoke'}, {'id': 'D052638', 'term': 'Particulate Matter'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000397', 'term': 'Air Pollution'}, {'id': 'D004787', 'term': 'Environmental Pollution'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-18', 'studyFirstSubmitDate': '2009-11-03', 'studyFirstSubmitQcDate': '2009-11-03', 'lastUpdatePostDateStruct': {'date': '2011-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brachial Artery Flow-mediated dilation (FMD)', 'timeFrame': 'Same day - before/after exposure'}], 'secondaryOutcomes': [{'measure': 'Plasma measurement of asymmetric dimethylarginine (ADMA) and Nitrotyrosine levels', 'timeFrame': 'Same day - before/after exposure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tobacco smoke', 'Oxidative stress', 'Endothelial Function', 'Atherosclerosis', 'Arterial Stiffness', 'Microvascular Function'], 'conditions': ['Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the vascular effects of brief second-hand smoke exposure on normal healthy individuals.', 'detailedDescription': 'Second-hand smoke remains a significant public health threat. Despite evidence to suggest that secondhand smoke contributes to adverse cardiovascular outcomes, little is known about the dose-dependent vascular effects of brief secondhand smoke exposure at low doses commonly encountered in the community. This study will investigate the acute vascular effects and dose-dependent biological mechanisms of secondhand smoke on endothelial function and oxidative stress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy non-smoking adults\n\nExclusion Criteria:\n\n* Reported Active Smoking\n* History of diabetes, hypertension, chronic respiratory disease, coronary artery disease, prior myocardial infarction or heart failure\n* Pregnancy or breastfeeding\n* Current use of prescription drugs within 14 days of trial\n* Reported significant passive smoke exposure or elevated cotinine levels'}, 'identificationModule': {'nctId': 'NCT01007760', 'briefTitle': 'Dose-dependent Effects of Second-hand Smoke on Vascular Function', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Dose-dependent Biological Mechanisms of Second-hand Smoke on Endothelial Function and Oxidative Stress', 'orgStudyIdInfo': {'id': 'TRDRP-18FT-0049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Room air', 'interventionNames': ['Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose exposure second-hand smoke', 'interventionNames': ['Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High dose exposure second-hand smoke', 'interventionNames': ['Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke']}], 'interventions': [{'name': 'Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke', 'type': 'OTHER', 'description': 'acute one time exposure', 'armGroupLabels': ['High dose exposure second-hand smoke', 'Low dose exposure second-hand smoke', 'Room air']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF San Francisco General Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Peter Ganz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSF San Francisco General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Peter Ganz, M.D.', 'oldOrganization': 'UCSF'}}}}