Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-01-02 @ 7:31 AM
Study NCT ID:
NCT00845169
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2009-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Nitric Oxide Synthase Isoforms in the Cardiovascular Effects of Air Pollution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019323', 'term': 'omega-N-Methylarginine'}], 'ancestors': [{'id': 'D001120', 'term': 'Arginine'}, {'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-01', 'studyFirstSubmitDate': '2009-02-17', 'studyFirstSubmitQcDate': '2009-02-17', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forearm blood flow measured by venous occlusion plethysmography during intraarterial infusion of nitric oxide synthase inhibitors L-NMMA, SMTC and 1400W and positive control norepinephrine.', 'timeFrame': '2-4 hours after exposure'}], 'secondaryOutcomes': [{'measure': 'Plasma nitrite concentration', 'timeFrame': 'During forearm study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Air Pollution', 'Nitric Oxide', 'Nitric Oxide Synthase', 'Diesel exhaust', 'endothelial dysfunction'], 'conditions': ['Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': 'Exposure to air pollution has been linked to increased cardiorespiratory morbidity and mortality. The exact component of air pollution that mediates this effect is unknown, but the link is strongest for fine combustion derived particulate matter derived from traffic sources. Recently, it has been demonstrated that inhalation of diesel exhaust impairs vascular vasomotor tone and endogenous fibrinolysis. The mechanism underlying these detrimental vascular is unclear, but is thought to be via oxidative stress and altered bioavailability of endogenous nitric oxide. In these studies we plan to elucidate the role of endogenous nitric oxide synthase isoforms (NO) in the adverse vascular responses observed following exposure to diesel exhaust.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n\nExclusion Criteria:\n\n* Regular medication use (except oral contraceptive pill)\n* Current smokers\n* Significant occupational exposure to air pollution\n* Intercurrent illness'}, 'identificationModule': {'nctId': 'NCT00845169', 'briefTitle': 'The Role of Nitric Oxide Synthase Isoforms in the Cardiovascular Effects of Air Pollution', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'The Role of Nitric Oxide Synthase Isoforms in the Cardiovascular Effects of Air Pollution', 'orgStudyIdInfo': {'id': 'DNR 08-185M/2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diesel Exposure', 'description': '1 hour exposure to diesel exhaust at 300 µg/m3 during intermittent exercise', 'interventionNames': ['Procedure: Forearm vascular study']}, {'type': 'EXPERIMENTAL', 'label': 'Air Exposure', 'description': '1 hour exposure to filtered air during intermittent exercise', 'interventionNames': ['Procedure: Forearm vascular study']}], 'interventions': [{'name': 'Forearm vascular study', 'type': 'PROCEDURE', 'otherNames': ['1400W', 'SMTC', 'L-NMMA', 'Noreadrenaline', 'NorAd'], 'description': 'Forearm venous occlusion plethysmography to measure forearm blood flow during intrabrachial infusion of nitric oxide synthase inhibitors L-NMMA (2-8 µg/min), S-methionyl-L-citrulline (25-200 nmol/min) and 1400W (100-1000 nmol/min) and positive control norepinephrine (60-540 pmol/min)', 'armGroupLabels': ['Air Exposure', 'Diesel Exposure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Umeå', 'country': 'Sweden', 'facility': 'Umeå University', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Anders Blomberg, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University'}, {'name': 'David E Newby, PhD FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Edinburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Lothian', 'class': 'OTHER_GOV'}, {'name': 'Umeå University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Lecturer and Specialty Registrar in Cardiology', 'investigatorFullName': 'Jeremy Langrish', 'investigatorAffiliation': 'University of Edinburgh'}}}}