Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-27 @ 9:29 PM
Study NCT ID:
NCT01123161
Status:
TERMINATED
Last Update Posted:
2017-04-05
First Post:
2010-04-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Intravascular Cooling in the Treatment of Stroke 2/3 Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D007035', 'term': 'Hypothermia'}, {'id': 'D002544', 'term': 'Cerebral Infarction'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020520', 'term': 'Brain Infarction'}], 'ancestors': [{'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064590', 'term': 'Cool-Down Exercise'}], 'ancestors': [{'id': 'D000096063', 'term': 'Post-Exercise Recovery Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lydenp@cshs.org', 'phone': '310-423-5166', 'title': 'Dr. Patrick Lyden', 'organization': 'Cedars-Sinai Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days.', 'description': 'Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Group1: IV t-PA and Normothermia', 'description': 'IV tpa and normothermia\n\nGroup1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia', 'otherNumAtRisk': 57, 'otherNumAffected': 53, 'seriousNumAtRisk': 57, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment', 'description': 'IV tpa and hypothermia and anti-shivering treatment\n\nhypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine and surface warming.', 'otherNumAtRisk': 63, 'otherNumAffected': 63, 'seriousNumAtRisk': 63, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Blood and lymphatic', 'notes': 'Total AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 33, 'numAffected': 19}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Endocrine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'GI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 30, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 50, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'General', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 38, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'immune', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 83, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 139, 'numAffected': 52}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Metabolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Muskuloskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Neoplasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nervous Systen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 54, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 46, 'numAffected': 37}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Psychiatric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Reproductive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 44, 'numAffected': 31}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 33, 'numAffected': 28}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Cardiac Disorders', 'notes': 'arrest, CHF, CAD, cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Infections', 'notes': 'bacteremia, sepsis, shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'injury', 'notes': 'contusion, muscle injury, pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Metabolism', 'notes': 'dehydration, metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'muskuloskeletal', 'notes': 'ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Neoplasm', 'notes': 'metastases to meninges', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nervous System Disorders', 'notes': 'agitation, herniation, oedema, carotid artery stenosis, cerebral hemorrhage, confusional state, ICH, sedation, stroke in evolution', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'psychiatric disorders', 'notes': 'delerium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'renal', 'notes': 'renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Respiratory', 'notes': 'ARDs, respiratory failure, pneumonia, PE, resp distress, resp depression, resp failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'vascular', 'notes': 'Arterial rupture, deep vein thrombosis, Hemorrhage, or hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Outcome is the Proportion of Patients Achieving a Favorable Outcome Defined as Modified Rankin Scale Score of 0 or 1, Assessed 90 Days After Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group1: IV t-PA and Normothermia', 'description': 'IV tpa and normothermia\n\nGroup1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia'}, {'id': 'OG001', 'title': 'Group 2 : IV t-PA and Hypothermia', 'description': 'IV tpa and hypothermia\n\nhypothermia: Hypothermia is induced using the Celsius Control™ System'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days', 'description': 'Modified Rankin describes disability: 0 is free of any disability or symptoms, 6 is death, and higher grades between 0 and 6 reflect progressively greater disability', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Population'}, {'type': 'PRIMARY', 'title': 'Incidence of Any Intracranial Hemorrhage (ICH) Within 48 Hours of Stroke Onset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group1: IV t-PA and Normothermia', 'description': 'IV tpa and normothermia\n\nGroup1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia'}, {'id': 'OG001', 'title': 'Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment', 'description': 'IV tpa and hypothermia and anti-shivering treatment\n\nhypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 hours', 'description': 'Incidence (number) of any intracranial hemorrhage (ICH) (whether or not symptomatic) within 48 hours of stroke onset will be presented by treatment group and overall.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat patients with imaging obtained 36 to 48 hours after treatment'}, {'type': 'PRIMARY', 'title': 'Incidence of Any Symptomatic Intracranial Hemorrhage (sICH) Within 48 Hours of Stroke Onset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group1: IV t-PA and Normothermia', 'description': 'IV tpa and normothermia\n\nGroup1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia'}, {'id': 'OG001', 'title': 'Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment', 'description': 'IV tpa and hypothermia and anti-shivering treatment\n\nhypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 hours', 'description': 'Incidence (number) of Symptomatic ICH (sICH) within 48 hours of stroke onset will be presented by treatment group and overall. Patients with neuroworsening (4 or more point increase in NIHSS , or a decline in the NIHSS consciousness item 1A score of more than 1 point, or a motor deterioration lasting more than 8 hours, all not due to iatrogenic cause) and hemorrhage seen on brain images in whom the investigator attributes the clinical change to the hemorrhage.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT patients in whom a brain image was obtained 36 yo 48 hours after treatment'}, {'type': 'PRIMARY', 'title': 'Incidence of Pneumonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group1: IV t-PA and Normothermia', 'description': 'IV tpa and normothermia\n\nGroup1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia'}, {'id': 'OG001', 'title': 'Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment', 'description': 'IV tpa and hypothermia and anti-shivering treatment\n\nhypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days or discharge whichever comes first', 'description': 'Number subjects diagnosed with pneumonia according to CDC criteria will be presented by treatment group and overall, regardless of seriousness', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': '90 Day Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group1: IV t-PA and Normothermia', 'description': 'IV tpa and normothermia\n\nGroup1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia'}, {'id': 'OG001', 'title': 'Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment', 'description': 'IV tpa and hypothermia and anti-shivering treatment\n\nhypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days', 'description': 'Mortality prior to the 90-day evaluation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'The Barthel Index Measure of Activities of Daily Living;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group1: IV t-PA and Normothermia', 'description': 'IV tpa and normothermia\n\nGroup1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia'}, {'id': 'OG001', 'title': 'Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment', 'description': 'IV tpa and hypothermia\n\nhypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering treatment includes buspirone, meperidine, and surface warming.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days', 'description': 'The Barthel index measures independence in activities of daily living from 0 (worst) to 100 (best) in 5 point increments. Higher scores between 0 and 100 reflect progressively greater levels of independence. Scores were dichotomized at 90 so that a score of 95 or 100 was considered a successful treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population with a 90-day Barthel index available was used, therefore the numbers are fewer than in the total population.'}, {'type': 'SECONDARY', 'title': 'NIHSS Scores at 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group1: IV t-PA and Normothermia', 'description': 'IV tpa and normothermia\n\nGroup1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia'}, {'id': 'OG001', 'title': 'Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment', 'description': 'IV tpa and hypothermia and anti-shivering treatment\n\nhypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '5.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'The National Institutes of Health Stroke Scale (NIHSS) is used to quantify neurological deficit. The scale ranges from 0 (best) to 42 points (worst). Between scores of 0 to 42, higher values reflect progressively greater deficit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat patients with an available 90-day NIHSS values therefore the total numbers available are fewer than the total ITT population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group1: IV t-PA and Normothermia', 'description': 'IV tpa and normothermia\n\nGroup1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia'}, {'id': 'FG001', 'title': 'Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment', 'description': 'IV tpa and hypothermia and anti-shivering treatment\n\nhypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group1: IV t-PA and Normothermia', 'description': 'IV tpa and normothermia\n\nGroup1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia'}, {'id': 'BG001', 'title': 'Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment', 'description': 'IV tpa and hypothermia and anti-shivering treatment\n\nhypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '65.5', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '66.4', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline NIHSS', 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '14.1', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '14.3', 'spread': '4.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The NIHSS measures neurological deficit. Scores range from 0 (best) to 42 (worst). Between 0 and 42 higher scores reflect progressively worse neurological deficit.', 'unitOfMeasure': 'points', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline temperature', 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'spread': '0.50', 'groupId': 'BG000'}, {'value': '36.6', 'spread': '0.46', 'groupId': 'BG001'}, {'value': '36.5', 'spread': '0.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'degrees (C)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Patients enrolled and randomized'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Randomized to normothermia or hypothermia'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'whyStopped': 'The ICTuS 2 portion of the trial has been halted and data will be analyzed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-18', 'studyFirstSubmitDate': '2010-04-27', 'resultsFirstSubmitDate': '2016-09-29', 'studyFirstSubmitQcDate': '2010-05-11', 'lastUpdatePostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-18', 'studyFirstPostDateStruct': {'date': '2010-05-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Outcome is the Proportion of Patients Achieving a Favorable Outcome Defined as Modified Rankin Scale Score of 0 or 1, Assessed 90 Days After Treatment.', 'timeFrame': '90 days', 'description': 'Modified Rankin describes disability: 0 is free of any disability or symptoms, 6 is death, and higher grades between 0 and 6 reflect progressively greater disability'}, {'measure': 'Incidence of Any Intracranial Hemorrhage (ICH) Within 48 Hours of Stroke Onset', 'timeFrame': '48 hours', 'description': 'Incidence (number) of any intracranial hemorrhage (ICH) (whether or not symptomatic) within 48 hours of stroke onset will be presented by treatment group and overall.'}, {'measure': 'Incidence of Any Symptomatic Intracranial Hemorrhage (sICH) Within 48 Hours of Stroke Onset', 'timeFrame': '48 hours', 'description': 'Incidence (number) of Symptomatic ICH (sICH) within 48 hours of stroke onset will be presented by treatment group and overall. Patients with neuroworsening (4 or more point increase in NIHSS , or a decline in the NIHSS consciousness item 1A score of more than 1 point, or a motor deterioration lasting more than 8 hours, all not due to iatrogenic cause) and hemorrhage seen on brain images in whom the investigator attributes the clinical change to the hemorrhage.'}, {'measure': 'Incidence of Pneumonia', 'timeFrame': '7 days or discharge whichever comes first', 'description': 'Number subjects diagnosed with pneumonia according to CDC criteria will be presented by treatment group and overall, regardless of seriousness'}, {'measure': '90 Day Mortality', 'timeFrame': '90 days', 'description': 'Mortality prior to the 90-day evaluation.'}], 'secondaryOutcomes': [{'measure': 'The Barthel Index Measure of Activities of Daily Living;', 'timeFrame': '90 days', 'description': 'The Barthel index measures independence in activities of daily living from 0 (worst) to 100 (best) in 5 point increments. Higher scores between 0 and 100 reflect progressively greater levels of independence. Scores were dichotomized at 90 so that a score of 95 or 100 was considered a successful treatment.'}, {'measure': 'NIHSS Scores at 90 Days', 'timeFrame': '90 days', 'description': 'The National Institutes of Health Stroke Scale (NIHSS) is used to quantify neurological deficit. The scale ranges from 0 (best) to 42 points (worst). Between scores of 0 to 42, higher values reflect progressively greater deficit.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypothermia', 'Molecular Mechanisms of Pharmacological Action', 'Cerebral Infarction', 'Hematologic Agents', 'Stroke', 'Nervous System Diseases', 'Vascular Diseases', 'Tissue Plasminogen Activator', 'Central Nervous System Diseases', 'Fibrinolytic Agents', 'Cardiovascular Agents', 'Body Temperature Changes', 'Brain Diseases', 'Cerebrovascular Disorders', 'Pharmacologic Actions', 'Signs and Symptoms', 'Fibrin Modulating Agents', 'Therapeutic Uses', 'Brain Ischemia', 'Cardiovascular Diseases', 'Brain Infarction', 'Plasminogen', 'cooling', 'tPA', 'thrombolysis'], 'conditions': ['Stroke, Acute']}, 'referencesModule': {'references': [{'pmid': '17904009', 'type': 'BACKGROUND', 'citation': 'Lyden PD, Allgren RL, Ng K, Akins P, Meyer B, Al-Sanani F, Lutsep H, Dobak J, Matsubara BS, Zivin J. Intravascular Cooling in the Treatment of Stroke (ICTuS): early clinical experience. J Stroke Cerebrovasc Dis. 2005 May-Jun;14(3):107-14. doi: 10.1016/j.jstrokecerebrovasdis.2005.01.001.'}, {'pmid': '20724711', 'type': 'BACKGROUND', 'citation': 'Hemmen TM, Raman R, Guluma KZ, Meyer BC, Gomes JA, Cruz-Flores S, Wijman CA, Rapp KS, Grotta JC, Lyden PD; ICTuS-L Investigators. Intravenous thrombolysis plus hypothermia for acute treatment of ischemic stroke (ICTuS-L): final results. Stroke. 2010 Oct;41(10):2265-70. doi: 10.1161/STROKEAHA.110.592295. Epub 2010 Aug 19.'}, {'pmid': '23667781', 'type': 'BACKGROUND', 'citation': 'Lyden P, Ernstrom K, Raman R. Determinants of Pneumonia Risk During Endovascular Hypothermia. Ther Hypothermia Temp Manag. 2013 Mar;3(1):24-27. doi: 10.1089/ther.2012.0021.'}, {'pmid': '22466971', 'type': 'BACKGROUND', 'citation': 'Lyden P, Ernstrom K, Cruz-Flores S, Gomes J, Grotta J, Mullin A, Rapp K, Raman R, Wijman C, Hemmen T. Determinants of effective cooling during endovascular hypothermia. Neurocrit Care. 2012 Jun;16(3):413-20. doi: 10.1007/s12028-012-9688-y.'}, {'pmid': '20817376', 'type': 'BACKGROUND', 'citation': 'Guluma KZ, Liu L, Hemmen TM, Acharya AB, Rapp KS, Raman R, Lyden PD. Therapeutic hypothermia is associated with a decrease in urine output in acute stroke patients. Resuscitation. 2010 Dec;81(12):1642-7. doi: 10.1016/j.resuscitation.2010.08.003.'}, {'pmid': '16766740', 'type': 'BACKGROUND', 'citation': 'Guluma KZ, Hemmen TM, Olsen SE, Rapp KS, Lyden PD. A trial of therapeutic hypothermia via endovascular approach in awake patients with acute ischemic stroke: methodology. Acad Emerg Med. 2006 Aug;13(8):820-7. doi: 10.1197/j.aem.2006.03.559. Epub 2006 Jun 9.'}, {'pmid': '27834742', 'type': 'DERIVED', 'citation': 'Lyden P, Hemmen T, Grotta J, Rapp K, Ernstrom K, Rzesiewicz T, Parker S, Concha M, Hussain S, Agarwal S, Meyer B, Jurf J, Altafullah I, Raman R; Collaborators. Results of the ICTuS 2 Trial (Intravascular Cooling in the Treatment of Stroke 2). Stroke. 2016 Dec;47(12):2888-2895. doi: 10.1161/STROKEAHA.116.014200. Epub 2016 Nov 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine whether the combination of thrombolysis and hypothermia is superior to thrombolysis alone for the treatment of acute ischemic stroke.', 'detailedDescription': "A stroke is usually caused by a blockage in one of the arteries that carries blood to the brain. Research has shown that tissue plasminogen activator (tPA)-a naturally occurring protein that opens blocked arteries by dissolving blood clots - activates the body's ability to dissolve recently formed blood clots and reduces or prevents the brain damage caused by a stroke.\n\nThe Food and Drug Administration (FDA) has approved the use of tPA for people having a stroke when taken within 3 hours of stroke onset.\n\nResearchers believe that a lower body temperature (hypothermia) may be beneficial while a stroke is happening because hypothermia may prevent further brain injury, or may make the stroke less damaging.\n\nPatients will receive a standard stroke evaluation, which includes blood tests, a computed tomography (CT) scan, complete physical and neurological examinations, and an electrocardiogram (EKG) to determine eligibility for the study.\n\nThere are two study groups - tPA alone or tPA with cooling (hypothermia). Participants will be randomly assigned to one of the two study groups. Length of participation (including observation after the patient leaves the hospital) is 90 days.\n\nThis study is part of the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which allows researchers to enhance and initiate translational research that ultimately will benefit stroke patients by treating more patients in less than 2 hours, and finding ways to treat additional patients later."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 22 to 82 years old inclusive\n2. Patient receiving IV rt-PA using standard guidelines\n3. NIHSS score ≥ 7 and ≤ 20 (right hemisphere) or ≥ 7 and ≤ 24 (left hemisphere) at the time of randomization\n4. Pre-stroke mRS 0-1\n5. Able to begin endovascular phase of hypothermia within 2 hours of tPA completion\n6. Written Informed Consent, signed and dated by the patient (or patient's authorized representative)\n\nExclusion Criteria:\n\n1. Etiology other than ischemic stroke\n2. Item 1a on NIHSS \\> 1 at the time of randomization\n3. Clinical symptoms consistent with brainstem or cerebellar stroke\n4. Classic lacunar syndrome with imaging confirmation of small deep ischemia, but randomization will not be delayed for neuroimaging other than initial scan to exclude hemorrhage\n5. Known contraindications to hypothermia, such as known hematologic dyscrasias that affect thrombosis (cryoglobulinemia, Sickle cell disease, serum cold agglutinins), or vasospastic disorders such as Raynaud's or thromboangiitis obliterans\n6. Known co-morbid conditions that are likely to complicate therapy in the opinion of the investigator, e.g., i. Heart failure (NYHA class III and IV)\\* ii. Uncompensated arrhythmia iii. Severe Liver disease iv. History of pelvic or abdominal mass likely to compress inferior vena cava v. IVC filters vi. HIV positive vii. Clinically active hypo or hyperthyroidism viii. Renal insufficiency likely to impair meperidine clearance ix. Chronic ethanol abuse x. History of HIT (heparin induced thrombocytopenia)\n7. Pregnancy (All women of child-bearing potential must have a negative pregnancy test, urine or blood, prior to therapy.)\n8. Medical conditions likely to interfere with patient assessment.\n9. Known allergy to meperidine or buspirone\n10. Currently taking or used within previous 14 days MAO-I class of medication.\n11. Life expectancy \\< 6 months\n12. Not likely to be available for long-term follow-up\n13. Use, or planned use, of intra-arterial thrombolysis, mechanical clot removal, or other experimental or approved acute therapy for this stroke event\n14. Chest radiograph or clinical presentation suggestive of pneumonia or clinically significant pulmonary edema at baseline.\n15. Temperature upon admission greater than or equal to 38°C"}, 'identificationModule': {'nctId': 'NCT01123161', 'acronym': 'ICTuS2/3', 'briefTitle': 'The Intravascular Cooling in the Treatment of Stroke 2/3 Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Phase 2/3 Study of Intravenous Thrombolysis and Hypothermia for Acute Treatment of Ischemic Stroke', 'orgStudyIdInfo': {'id': 'ICTuS2/3'}, 'secondaryIdInfos': [{'id': 'P50NS044148', 'link': 'https://reporter.nih.gov/quickSearch/P50NS044148', 'type': 'NIH'}, {'id': 'P50NS044227', 'link': 'https://reporter.nih.gov/quickSearch/P50NS044227', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group1: IV t-PA and normothermia', 'description': 'IV tpa and normothermia', 'interventionNames': ['Drug: Group1: IV t-PA and normothermia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2 : IV t-PA and hypothermia and anti-shivering treatment', 'description': 'IV tpa and hypothermia and anti-shivering treatment', 'interventionNames': ['Device: hypothermia and anti-shivering treatment']}], 'interventions': [{'name': 'hypothermia and anti-shivering treatment', 'type': 'DEVICE', 'otherNames': ['cooling'], 'description': 'Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine and surface warming', 'armGroupLabels': ['Group 2 : IV t-PA and hypothermia and anti-shivering treatment']}, {'name': 'Group1: IV t-PA and normothermia', 'type': 'DRUG', 'description': 'Group 1 will t-PA as standard of care and normothermia', 'armGroupLabels': ['Group1: IV t-PA and normothermia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama Hospital', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92658', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Memorial Hospital Presbyterian', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Health System', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Mercy Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Gulf Coast Medical Center', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami, Jackson Memorial Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Intercoastal Medical Group', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "St. Joseph's Hospital", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60007', 'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alexian Brothers Medical Center', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'zip': '46805', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Parkview Hospital', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Ruan Neurology Clinic and Research Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48824', 'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan State University', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}, {'zip': '55422', 'city': 'Robbinsdale', 'state': 'Minnesota', 'country': 'United States', 'facility': 'North Memorial Medical Center', 'geoPoint': {'lat': 45.03219, 'lon': -93.33856}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University Medical Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43614', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Toledo Medical Center', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '19001', 'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Memorial Hospital', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Valley Health Network', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Seton Medical Center Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Medical University Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Patrick D. Lyden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}, {'name': 'Thomas M. Hemmen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California, San Diego'}, {'name': 'James C. Grotta, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}, {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Patrick Lyden', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}