Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2026-01-01 @ 2:42 PM
Study NCT ID:
NCT00809432
Status:
COMPLETED
Last Update Posted:
2008-12-17
First Post:
2008-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Cardiovascular Benefits of Reducing Personal Exposure to Air Pollution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008397', 'term': 'Masks'}], 'ancestors': [{'id': 'D058257', 'term': 'Surgical Attire'}, {'id': 'D004865', 'term': 'Equipment and Supplies, Hospital'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-15', 'studyFirstSubmitDate': '2008-12-15', 'studyFirstSubmitQcDate': '2008-12-15', 'lastUpdatePostDateStruct': {'date': '2008-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ambulatory blood pressure', 'timeFrame': 'During 24 hour study period'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'During 24 hour study period'}, {'measure': 'Heart rate variability', 'timeFrame': 'During 24 hour study period'}, {'measure': 'Personal air pollution exposure', 'timeFrame': 'During 2 hour city centre walk'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Air pollution', 'Heart rate', 'Heart rate variability', 'Blood pressure', 'Face mask'], 'conditions': ['Blood Pressure', 'Heart Rate Variability']}, 'referencesModule': {'references': [{'pmid': '24667535', 'type': 'DERIVED', 'citation': 'Langrish JP, Watts SJ, Hunter AJ, Shah AS, Bosson JA, Unosson J, Barath S, Lundback M, Cassee FR, Donaldson K, Sandstrom T, Blomberg A, Newby DE, Mills NL. Controlled exposures to air pollutants and risk of cardiac arrhythmia. Environ Health Perspect. 2014 Jul;122(7):747-53. doi: 10.1289/ehp.1307337. Epub 2014 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'Exposure to air pollution is an important risk factor for cardiovascular morbidity and mortality, and is associated with increased blood pressure, reduced heart rate variability, endothelial dysfunction and myocardial ischaemia. The study objectives were to assess the potential cardiovascular benefits of reducing personal particulate air pollution exposure by wearing a facemask in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n\nExclusion Criteria:\n\n* Current smokers\n* Significant occupational exposure to air pollution\n* Regular medication use (except oral contraceptive pill)\n* Intercurrent illness'}, 'identificationModule': {'nctId': 'NCT00809432', 'briefTitle': 'The Cardiovascular Benefits of Reducing Personal Exposure to Air Pollution', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'Beneficial Cardiovascular Effects of Reducing Exposure to Particulate Air Pollution With a Simple Facemask', 'orgStudyIdInfo': {'id': '167/2008/Pilot'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Visit 1', 'description': '2 hour city centre kerbside walk in Beijing China', 'interventionNames': ['Other: No Face mask']}, {'type': 'EXPERIMENTAL', 'label': 'Visit 2', 'description': '2 hour city centre kerbside walk in Beijing China', 'interventionNames': ['Device: Face mask (Dust Respirator)']}], 'interventions': [{'name': 'Face mask (Dust Respirator)', 'type': 'DEVICE', 'otherNames': ['3M Dust Respirator 8812'], 'description': 'Subjects to wear a simple face mask for 24 hours prior to the study day and the 24 hours of the study day. They will be instructed to wear the mask as much as possible when indoors and at all times when outdoors.', 'armGroupLabels': ['Visit 2']}, {'name': 'No Face mask', 'type': 'OTHER', 'description': 'Subjects will not wear a face mask to reduce their personal exposure to air pollution', 'armGroupLabels': ['Visit 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Medical Union College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jeremy P Langrish, MB BCh MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Edinburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking Union Medical College', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Professor David E Newby', 'oldOrganization': 'University of Edinburgh'}}}}