Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT00373269
Status:
COMPLETED
Last Update Posted:
2017-02-27
First Post:
2006-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D013927', 'term': 'Thrombosis'}], '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'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ngentile@temple.edu', 'phone': '215-707-8402', 'title': 'Dr. Nina T. Gentile', 'organization': 'Temple University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Serious and Other (Not Including Serious) Adverse Events were not collected/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Diabetic Subject', 'description': 'Subjects with acute stroke, hyperglycemia and history of diabetes.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normoglycemic Control', 'description': 'Subjects with acute stroke and normal blood glucose.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'FVIIa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normoglycemic Control', 'description': 'Subjects with acute ischemic stroke and normal blood glucose.'}, {'id': 'OG001', 'title': 'Hyperglycemic Subjects', 'description': 'Subjects with acute ischemic stroke and hyperglycemia.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.7', 'spread': '33.3', 'groupId': 'OG000'}, {'value': '124.4', 'spread': '35.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'FVIIa levels were compared between the normoglycemic and hyperglycemic subjects.', 'unitOfMeasure': 'mU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'TF-PCA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normoglycemic Control', 'description': 'Subjects with acute ischemic stroke and normal blood glucose.'}, {'id': 'OG001', 'title': 'Hyperglycemic Subjects', 'description': 'Subjects with acute ischemic stroke and hyperglycemia.'}], 'classes': [{'categories': [{'measurements': [{'value': '183.5', 'spread': '63.1', 'groupId': 'OG000'}, {'value': '118.1', 'spread': '56.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'TF-PCA levels compared between normoglycemic and hyperglycemic subjects.', 'unitOfMeasure': 'U/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normoglycemic Control', 'description': 'Subjects with acute ischemic stroke and normal blood glucose.'}, {'id': 'FG001', 'title': 'Hyperglycemic Subjects', 'description': 'Subjects with acute ischemic stroke and hyperglycemia.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Normoglycemic', 'description': 'Subjects with acute ischemic stroke and normal blood glucose.'}, {'id': 'BG001', 'title': 'Hyperglycemic', 'description': 'Subjects with acute ischemic stroke and hyperglycemia.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.9', 'spread': '17.7', 'groupId': 'BG000'}, {'value': '63.5', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '64.2', 'spread': '18.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '2006-09-05', 'resultsFirstSubmitDate': '2016-11-04', 'studyFirstSubmitQcDate': '2006-09-07', 'lastUpdatePostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-04', 'studyFirstPostDateStruct': {'date': '2006-09-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FVIIa', 'timeFrame': 'Baseline', 'description': 'FVIIa levels were compared between the normoglycemic and hyperglycemic subjects.'}], 'secondaryOutcomes': [{'measure': 'TF-PCA', 'timeFrame': 'Baseline', 'description': 'TF-PCA levels compared between normoglycemic and hyperglycemic subjects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute ischemic stroke', 'Stroke', 'Hyperglycemia', 'Procoagulation', 'Diabetes', 'Blood coagulation'], 'conditions': ['Ischemic Stroke', 'Hyperglycemia']}, 'descriptionModule': {'briefSummary': 'Between twenty and fifty percent of people who have acute stroke have hyperglycemia (high blood sugar) with it. The purpose of this study is to examine the relationships between diabetes mellitus, hyperglycemia,whole blood tissue factor procoagulant activity (TF-PCA) and plasma factorVIIa (FVIIa) in ten patients with type 2 diabetes mellitus and 11 non-diabetic patients at baseline and 6, 12, 24, and 48 hours (h) after presentation for acute stroke.', 'detailedDescription': 'The purpose of this study is to examine the relationships between diabetes mellitus, hyperglycemia,whole blood tissue factor procoagulant activity (TF-PCA) and plasma factorVIIa (FVIIa) in ten patients with type 2 diabetes mellitus and 11 non-diabetic patients at baseline and 6, 12, 24, and 48 hours (h) after presentation for acute stroke.\n\nPatients presenting to the Emergency Department with ongoing stroke symptoms and neurologic deficit less than 24 hours (h) duration were screened for inclusion into the study. Stroke patients were grouped in terms of diabetes status as determined by past medical history. Stroke diagnosis was confirmed with brain magnetic resonance imaging (MRI). Clinical care, including the acute management ofstroke and hyperglycemia, was done at the discretion of the Neurology service not involved in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to the Emergency Department with acute ischemic stroke within 12 hours of onset of symptoms.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged \\> 18 years presenting to the Emergency Department with symptoms of acute ischemic stroke will be included for study.\n* Acute stroke patients with normal blood glucose levels and patients with fingerstick blood glucose level of greater than or equal to 150 mg/dl will be eligible for study.\n* Acute Stroke will be defined as an acute disturbance of cerebral function of presumed vascular origin causing a neurological deficit of less than 24 hours duration.\n* Patients must have an NIH Stroke Scale Score of 4 to 23. Patients awakening with symptoms of stroke will be considered to have had their stroke at the time when last awake without symptoms.\n\nExclusion Criteria:\n\n* Patients presenting after 24 hours of symptom onset. When the actual time of onset is unknown, the time when last observed to be symptom-free will be used.\n* Patients with NIH scale of less than 4 or greater than 23.\n* Complete or substantial resolution of symptoms before randomization.\n* Patients with a previously disabling stroke (modified Rankin score \\> 3)\n* Patients with other systemic disease such as infection (eg pneumonia, etc)\n* Patients with hemorrhage visualized on CT.\n* Patients who are unwilling or unable to give informed consent, or for whom a legally authorized representative is not able to consent.\n* Pregnant patients.'}, 'identificationModule': {'nctId': 'NCT00373269', 'briefTitle': 'Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Temple University'}, 'officialTitle': 'Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study', 'orgStudyIdInfo': {'id': '3866 4187'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic subject', 'description': 'Subjects with acute stroke, hyperglycemia and history of diabetes.'}, {'label': 'Normoglycemic Control', 'description': 'Subjects with acute stroke and normal blood glucose.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nina T Gentile, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Temple University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Temple University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}