Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-24 @ 5:50 AM
Study NCT ID:
NCT02860260
Status:
COMPLETED
Last Update Posted:
2016-08-09
First Post:
2016-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kinetics of Plasma and Serum Levels of Brain-Derived Neurotrophic Factor (BDNF) in Patients With Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'lastUpdateSubmitDate': '2016-08-08', 'studyFirstSubmitDate': '2016-08-01', 'studyFirstSubmitQcDate': '2016-08-08', 'lastUpdatePostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of plasma levels of BDNF', 'timeFrame': 'Change from baseline at Day1, Day 7 and Month 3'}, {'measure': 'Measurement of serum levels of BDNF', 'timeFrame': 'Change from baseline at Day1, Day 7 and Month 3'}]}, 'conditionsModule': {'keywords': ['BDNF'], 'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to show for the first time that treatment with intravenous fibrinolysis using rt-PA in patients with recent ischemic stroke is accompanied by increases in circulating levels of BDNF, which may reflect an increase in BDNF synthesis in the brain.\n\nThe analysis of the recovery of functional and cognitive abilities as well as mood at 3 months will allow us to study the impact of BDNF on these parameters. Thus, depending on the results obtained, circulating BDNF could serve as an early marker of these.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients (or their person of trust in cases of inability) who have been informed about the research and given their consent to take part\n* Patients aged 18 years or older\n* Patients who have suffered a de novo recent ischemic stroke \\< 12 hours\n* Patients who had cerebral imaging (CT-Scan or MRI)\n* Ischemic stroke severity, measured by the National Institute of Health Stroke Score (NIHSS), between 4 and 20\n\nExclusion Criteria:\n\nPatients without national health insurance cover\n\n* Patients with a clinical history of stroke\n* Patients with cerebral or sub-arachnoid haemorrhage\n* Patients with a transient ischemic attack\n* Time of symptom onset unknown\n* Patients with severe aphasia at the time of the ischemic stroke defined by a sub-score for item 9 (best language) of the NIHSS ≥ 2\n* Patients with dementia prior to the ischemic stroke\n* Patients with a significant loss of autonomy prior to the ischemic stroke, defined by a Rankin score ≥ 4\n* Patients with aphasia before the ischemic stroke\n* Patients with a contra-indication for cerebral MRI\n* Pregnant or breast-feeding women\n* Adults under guardianship\n* Subjects in custody\n* Patients who do not speak French'}, 'identificationModule': {'nctId': 'NCT02860260', 'acronym': 'BDNF', 'briefTitle': 'Kinetics of Plasma and Serum Levels of Brain-Derived Neurotrophic Factor (BDNF) in Patients With Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Kinetics of Plasma and Serum Levels of Brain-Derived Neurotrophic Factor (BDNF) in Patients With Ischemic Stroke: Effect of Intravenous Fibrinolysis With Rt-PA', 'orgStudyIdInfo': {'id': 'BEJOT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with fibrinolysis', 'interventionNames': ['Biological: Blood samples', 'Other: Cerebral MRI']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Patients without fibrinolysis', 'interventionNames': ['Biological: Blood samples', 'Other: Cerebral MRI']}], 'interventions': [{'name': 'Blood samples', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Patients with fibrinolysis', 'Patients without fibrinolysis']}, {'name': 'Cerebral MRI', 'type': 'OTHER', 'armGroupLabels': ['Patients with fibrinolysis', 'Patients without fibrinolysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}