Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-02 @ 11:59 AM
Study NCT ID:
NCT00512369
Status:
TERMINATED
Last Update Posted:
2011-07-18
First Post:
2007-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of PA-1 Transcriptional Regulation on Monocyte Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'whyStopped': 'Investigator left institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-14', 'studyFirstSubmitDate': '2007-08-03', 'studyFirstSubmitQcDate': '2007-08-06', 'lastUpdatePostDateStruct': {'date': '2011-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-07', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metabolic pathways', 'Atherosclerosis', 'Monocyte Function'], 'conditions': ['Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'Researching genetic differences in people with no prior medical conditions for better understanding of cardiac diseases through genetic research.', 'detailedDescription': 'The discovery and subsequent application of small interfering RNA (siRNA) methods to achieve individual gene silencing in mammalian cells is a robust method that is well-described and validated in mammalian cell culture systems. We will apply this technique to achieve post-transcriptional "silencing" of PAI-1 in monocytes obtained from otherwise healthy volunteers, and study the subsequent loss of this gene\'s function on the migratory capacity of these cells in the proposed in vitro experimental system. This concept has not yet been demonstrated in the literature, and if validated, would be a novel and fundamental description of the role of PAI-1 in human monocyte biology as related to the development of atherosclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Obese men and women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18 -50\n* No current or past medical problems\n\nExclusion Criteria:\n\n* Patients taking prescription drugs (hormonal birth control or herbal supplements may be taken.'}, 'identificationModule': {'nctId': 'NCT00512369', 'briefTitle': 'Effects of PA-1 Transcriptional Regulation on Monocyte Function', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Angiotensin, the Vascular Endothelium, and Fibrinolysis - The Effects of PAI-1 Transcriptional Regulation on Human Monocyte Function', 'orgStudyIdInfo': {'id': '060286'}, 'secondaryIdInfos': [{'id': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Mohan Sathyamoorthy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Douglas Vaughan', 'oldOrganization': 'Vanderbilt University'}}}}