Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-27 @ 10:28 PM
Study NCT ID:
NCT01502761
Status:
TERMINATED
Last Update Posted:
2017-08-28
First Post:
2011-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intra-arterial Magnesium Administration for Acute Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D008278', 'term': 'Magnesium Sulfate'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'william.mack@med.usc.edu', 'phone': '323 442 7512', 'title': 'Dr. William J Mack', 'organization': 'University of Southern California'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The trial was terminated early (with enrollment only in the first arm) by the investigators due to low enrollment (given results of relevant studies at the time) . There were no safety concerns with the trial or the agent.'}}, 'adverseEventsModule': {'timeFrame': '90 days', 'eventGroups': [{'id': 'EG000', 'title': 'Regional Intra-arterial Magnesium 0.75g', 'description': 'Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients\n\nMagnesium Sulfate: Intra-arterial', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Regional Intra-arterial Magnesium 1.5g', 'description': 'Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients\n\nMagnesium Sulfate: Intra-arterial', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Regional/ Distal (75/25%) Magnesium 1.5g', 'description': 'Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients\n\nMagnesium Sulfate: Intra-arterial', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Regional/ Distal (50/50%) Magnesium 1.5g', 'description': 'Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients\n\nMagnesium Sulfate: Intra-arterial', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cerebral Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemic change on brain imaging', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhagic Transformation of stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sick Sinus Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspiration Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'increased blood glucose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Aspiration Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Parotiditis with sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Magnesium Concentration in Region of Cerebral Ischemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Regional Intra-arterial Magnesium 0.75g', 'description': 'Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients\n\nMagnesium Sulfate: Intra-arterial'}, {'id': 'OG001', 'title': 'Regional Intra-arterial Magnesium 1.5g', 'description': 'Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients\n\nMagnesium Sulfate: Intra-arterial'}, {'id': 'OG002', 'title': 'Regional/ Distal (75/25%) Magnesium 1.5g', 'description': 'Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients\n\nMagnesium Sulfate: Intra-arterial'}, {'id': 'OG003', 'title': 'Regional/ Distal (50/50%) Magnesium 1.5g', 'description': 'Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients\n\nMagnesium Sulfate: Intra-arterial'}], 'classes': [{'title': 'Distal Mg level', 'categories': [{'measurements': [{'value': '1.475', 'spread': '.3403', 'groupId': 'OG000'}]}]}, {'title': 'Peripheral Mg level', 'categories': [{'measurements': [{'value': '1.513', 'spread': '.2462', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever', 'description': 'Peripheral Magnesium Levels, meq/L will be obtained through the femoral sheath at the beginning (baseline) and end (post-treatment) of each case. These will be averaged to obtain a femoral Magnesium level. Magnesium levels distal to the occlusion will be measured at the first pass of the clot retrieving device.', 'unitOfMeasure': 'meq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrollment only occurred in the first arm (lowest dose) of the study as the arms were planned to enroll sequentially. The study was not stopped due to safety concerns'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Procedure Related Serious Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Regional Intra-arterial Magnesium 0.75g', 'description': 'Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients\n\nMagnesium Sulfate: Intra-arterial'}, {'id': 'OG001', 'title': 'Regional Intra-arterial Magnesium 1.5g', 'description': 'Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients\n\nMagnesium Sulfate: Intra-arterial'}, {'id': 'OG002', 'title': 'Regional/ Distal (75/25%) Magnesium 1.5g', 'description': 'Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients\n\nMagnesium Sulfate: Intra-arterial'}, {'id': 'OG003', 'title': 'Regional/ Distal (50/50%) Magnesium 1.5g', 'description': 'Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients\n\nMagnesium Sulfate: Intra-arterial'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'intraprocedure, postoperative day 1, 1 month, 3 month', 'description': 'Periprocedural clinical, radiographic and laboratory data will be collected and analyzed to detect Mg related adverse events. Outcome will be assessed perioperatively and at 24 hours, 30 days (+/- 10 days) and 90 days (+/- 15 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Regional Intra-arterial Magnesium 0.75g', 'description': 'Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients\n\nMagnesium Sulfate: Intra-arterial'}, {'id': 'FG001', 'title': 'Regional Intra-arterial Magnesium 1.5g', 'description': 'Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients\n\nMagnesium Sulfate: Intra-arterial'}, {'id': 'FG002', 'title': 'Regional/ Distal (75/25%) Magnesium 1.5g', 'description': 'Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients\n\nMagnesium Sulfate: Intra-arterial'}, {'id': 'FG003', 'title': 'Regional/ Distal (50/50%) Magnesium 1.5g', 'description': 'Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients\n\nMagnesium Sulfate: Intra-arterial'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Regional Intra-arterial Magnesium 0.75g', 'description': 'Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients\n\nMagnesium Sulfate: Intra-arterial'}, {'id': 'BG001', 'title': 'Regional Intra-arterial Magnesium 1.5g', 'description': 'Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients\n\nMagnesium Sulfate: Intra-arterial'}, {'id': 'BG002', 'title': 'Regional/ Distal (75/25%) Magnesium 1.5g', 'description': 'Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients\n\nMagnesium Sulfate: Intra-arterial'}, {'id': 'BG003', 'title': 'Regional/ Distal (50/50%) Magnesium 1.5g', 'description': 'Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients\n\nMagnesium Sulfate: Intra-arterial'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.25', 'spread': '13.25', 'groupId': 'BG000'}, {'value': '68.25', 'spread': '13.25', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '4 patients were enrolled (regional intra-arterial Magnesium 0.75g) before the study was stopped (not due to safety concerns). They were all enrolled in the first group'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'No safety issues. Low enrollment secondary to negative stroke studies 2013', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-26', 'studyFirstSubmitDate': '2011-12-22', 'resultsFirstSubmitDate': '2017-06-30', 'studyFirstSubmitQcDate': '2011-12-29', 'lastUpdatePostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-26', 'studyFirstPostDateStruct': {'date': '2012-01-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnesium Concentration in Region of Cerebral Ischemia', 'timeFrame': 'Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever', 'description': 'Peripheral Magnesium Levels, meq/L will be obtained through the femoral sheath at the beginning (baseline) and end (post-treatment) of each case. These will be averaged to obtain a femoral Magnesium level. Magnesium levels distal to the occlusion will be measured at the first pass of the clot retrieving device.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Procedure Related Serious Adverse Event', 'timeFrame': 'intraprocedure, postoperative day 1, 1 month, 3 month', 'description': 'Periprocedural clinical, radiographic and laboratory data will be collected and analyzed to detect Mg related adverse events. Outcome will be assessed perioperatively and at 24 hours, 30 days (+/- 10 days) and 90 days (+/- 15 days)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stroke', 'Magnesium', 'endovascular'], 'conditions': ['Acute Stroke']}, 'descriptionModule': {'briefSummary': 'Stroke is the second leading cause of death and the leading cause of adult disability worldwide. This investigation will address the safety and feasibility of directed, intra-arterial Magnesium measurement and therapy, through endovascular access, in acute stroke patients. The proposal represents the first study to directly quantify levels of a systemically administered neuroprotectant in the region of cerebral ischemia. It also establishes a novel endovascular platform for direct delivery of neuroprotective agents to ischemic cerebral tissue distal to an occlusive thrombus. This research seeks to improve patient care by establishing a novel delivery mechanism for the rescue of threatened brain parenchyma that can be administered rapidly following acute stroke. If successful, this selective distribution will allow delivery to "at risk" tissue in a rapid manner. Salvage of viable, but threatened, penumbral tissue could afford stroke patients an increased probability of favorable long term outcome. The investigators hypothesize that endovascular, intra-arterial, Magnesium administration will deliver high concentration of this neuroprotective agent to otherwise inaccessible cerebral territories, while limiting systemic concentrations. The proposed investigation will evaluate the safety and feasibility of this novel treatment technique'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient with acute cerebral ischemia due to ICA or MCA occlusion,\n2. Patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care.\n3. Age 21-95.\n\nExclusion Criteria:\n\n1. Severe renal impairment with creatinine 3.0 or higher,\n2. Myasthenia gravis,\n3. Second or third degree heart block without a pacemaker in place,\n4. Technical inability to navigate microcatheter to target clot,\n5. Patient already enrolled in another experimental treatment trial. Exclusion criteria 1-3 are all contraindications to magnesium therapy."}, 'identificationModule': {'nctId': 'NCT01502761', 'briefTitle': 'Intra-arterial Magnesium Administration for Acute Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Intra-arterial Magnesium Therapy: A Novel Platorm for Neuroprotectant Delivery in Acute Stroke', 'orgStudyIdInfo': {'id': 'HS-11-00339'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regional Intra-arterial Magnesium 0.75g', 'description': 'Regional Intra-arterial magnesium only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients', 'interventionNames': ['Drug: Magnesium Sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Regional Intra-arterial magnesium 1.5g', 'description': 'Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients', 'interventionNames': ['Drug: Magnesium Sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Regional/ Distal (75/25%) Magnesium 1.5g', 'description': 'Regional/ Distal intra-arterial magnesium (75% TD regional- 1.125g / 25% distal-0.375g): 5 patients', 'interventionNames': ['Drug: Magnesium Sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Regional/ Distal (50/50%) Magnesium 1.5g', 'description': 'Regional/ Distal intra-arterial magnesium (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients', 'interventionNames': ['Drug: Magnesium Sulfate']}], 'interventions': [{'name': 'Magnesium Sulfate', 'type': 'DRUG', 'description': 'Intra-arterial', 'armGroupLabels': ['Regional Intra-arterial Magnesium 0.75g', 'Regional Intra-arterial magnesium 1.5g', 'Regional/ Distal (50/50%) Magnesium 1.5g', 'Regional/ Distal (75/25%) Magnesium 1.5g']}]}, 'contactsLocationsModule': {'locations': [{'zip': '900094', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University California Los Angeles: Ronald Reagan and Santa Monica Hospitals', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California University and LA County Hospitals', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'William J Mack, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}, {'name': 'Jeffrey Saver, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Los Angeles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Neurosurgery', 'investigatorFullName': 'William Mack', 'investigatorAffiliation': 'University of Southern California'}}}}