Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-30 @ 7:06 PM
Study NCT ID:
NCT01365104
Status:
COMPLETED
Last Update Posted:
2015-01-28
First Post:
2011-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modulation of Cerebral Blood Flow Using Iron Chelators
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003676', 'term': 'Deferoxamine'}], 'ancestors': [{'id': 'D006877', 'term': 'Hydroxamic Acids'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-26', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-06-01', 'lastUpdatePostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Define change from baseline cerebral blood flow after receiving DFO infusion.', 'timeFrame': 'baseline, 3hr, 6hr, 9hr', 'description': 'Cerebral blood flow is measured with transcranial Doppler ultrasound at baseline and then study drug is initiated. Blood flow is measured again after 3 hours of infusion, 6 hours of infusion, then once more 3 hours after the infusion is complete.'}, {'measure': 'Determine if DFO changes blood HIF-1 levels from baseline and whether this correlates with changes in cerebrovascular hemodynamics.', 'timeFrame': 'baseline, 3hr, 6hr, 9hr', 'description': 'Blood samples are taken at each time point and will be correlated with ultrasound blood flow measures taken at baseline, 3hrs of infusion, 6hrs of infusion, and 3 hours after infusion is complete.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['brain blood flow', 'stroke', 'cerebrovascular', 'aging', 'cerebrovascular hemodynamics'], 'conditions': ['Stroke', 'Problem of Aging']}, 'referencesModule': {'references': [{'pmid': '26304864', 'type': 'DERIVED', 'citation': 'Sorond FA, Tan CO, LaRose S, Monk AD, Fichorova R, Ryan S, Lipsitz LA. Deferoxamine, Cerebrovascular Hemodynamics, and Vascular Aging: Potential Role for Hypoxia-Inducible Transcription Factor-1-Regulated Pathways. Stroke. 2015 Sep;46(9):2576-83. doi: 10.1161/STROKEAHA.115.009906. Epub 2015 Jul 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is determine if the iron chelator, desferrioxamine can increase blood levels of hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there is a corresponding increase in blood flow to the brain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy adults between the ages of 18-80 years.\n\nExclusion Criteria:\n\n* subjects taking vasoactive medications,\n* hypertension,\n* pregnant women, smokers,\n* COPD,\n* asthma,\n* diabetes mellitus,\n* intracranial or carotid stenosis,\n* hepatic disease,\n* renal disease,\n* bone marrow suppression,\n* cardiac disease,\n* heart failure,\n* iron deficiency,\n* history of cancer,\n* history of head trauma,\n* subarachnoid hemorrhage,\n* central nervous system vasculitis,\n* multiple sclerosis,\n* migraines,\n* seizures,\n* sickle cell disease or trait,\n* cardiac arrhythmia,\n* unable to give informed consent, or\n* poor transcranial Doppler insonation windows.'}, 'identificationModule': {'nctId': 'NCT01365104', 'acronym': 'DFO', 'briefTitle': 'Modulation of Cerebral Blood Flow Using Iron Chelators', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Hypoxia-Inducible Transcription Factor 1 (HIF-1)in Vascular Aging', 'orgStudyIdInfo': {'id': '1K23AG030967-01', 'link': 'https://reporter.nih.gov/quickSearch/1K23AG030967-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1K23AG030967-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K23AG030967-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy young', 'description': 'Each subject comes for 2 visits. There is a randomized, double-blind, crossover design so each subject will receive active drug during one visit and placebo during the other.', 'interventionNames': ['Drug: desferrioxamine']}, {'type': 'EXPERIMENTAL', 'label': 'healthy old', 'description': 'Each subject comes for 2 visits. There is a randomized, double-blind, crossover design so each subject will receive active drug during one visit and placebo during the other.', 'interventionNames': ['Drug: desferrioxamine']}], 'interventions': [{'name': 'desferrioxamine', 'type': 'DRUG', 'otherNames': ['Desferal, desferoxamine'], 'description': 'intravenous infusion at 10mg/kg/hr for a total of 6 hours at final infused doses of 60mg/kg.', 'armGroupLabels': ['Healthy young', 'healthy old']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Farzaneh Sorond, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Farzaneh Sorond', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}