Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-03-01 @ 10:08 AM
Study NCT ID:
NCT00627068
Status:
COMPLETED
Last Update Posted:
2011-09-20
First Post:
2008-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-16', 'studyFirstSubmitDate': '2008-02-21', 'studyFirstSubmitQcDate': '2008-02-28', 'lastUpdatePostDateStruct': {'date': '2011-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cardiovascular', 'vasodilation', 'endothelium', 'Subjects with high cardiovascular risk'], 'conditions': ['Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'Our main hypothesis is that EPC function is impaired in some populations with high cardiovascular risk as a result of reduced eNOS-dependent NO production.', 'detailedDescription': 'To determine if a correlation exists between EPC function and eNOS-dependent NO production in EPCs from populations with high versus low cardiovascular risk:\n\n1. High and low cardiovascular risk subjects will be identified based on age or history of cardiovascular disease. Endothelial function will be measured by ultrasound.\n2. EPCs will be isolated from peripheral blood of these subjects. EPC function will be assessed by measuring adhesion to endothelium, migration, proliferation, and differentiation, and compared to their expression and activity of eNOS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Population in both low and high risk groups should represent the general population.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to give written informed consent and comply with study requirements\n* Adult of 18 years or older\n* Subjects willing to provide blood and tissue samples\n\nExclusion Criteria:\n\n* Failure to give informed consent.\n* Those unable to consent for themselves.\n* Those who cannot read English.\n* Patients on Viagra, Levitra, or Cialis\n* Patients with malignant disease\n* Patients with hematological abnormalities\n* Patients with fevers of unknown origin\n* Severe comorbidity or alcohol/drug dependence\n* Women who are post-menopausal and on hormone replacement therapy, or premenopausal and on birth control pills (premenopausal women will be screened verbally and then by assay of LH and FSH levels in blood samples to identify women in the follicular phase of their menstrual cycle, to reduce variability)'}, 'identificationModule': {'nctId': 'NCT00627068', 'briefTitle': 'The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function', 'orgStudyIdInfo': {'id': 'HL086917'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'High cardiovascular risk age over 61 years.'}, {'label': '2', 'description': 'Low Cardiovascular risk age over 61.'}, {'label': '3', 'description': 'High cardiovascular risk age over 25 but under 61.'}, {'label': '4', 'description': 'Low cardiovascular risk age over 25 under 61.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF, Department of Cardiology', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Yerem Yeghiazarians, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Clinical Professor', 'investigatorFullName': 'Yerem Yeghiazarians', 'investigatorAffiliation': 'University of California, San Francisco'}}}}