Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT06273020
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'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'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C006952', 'term': 'cerebrolysin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are 3 groups in this clinical trial\n\nGroup 1: 20 patients with previous intravenous thrombolysis (IVT) in the qualifying stroke and who agreed to receive and got selected (through randomization) cerebrolysin.\n\nGroup 2 : 20 patients with previous IVT in the qualifying stroke and who agreed to receive cerebrolysin but they were not choose through randomization.\n\nGroup 3: 20 patients that they were not candidates to receive IVT (out of therapeutic window) but agreed to receive cerebrolysin (randomization not used)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2024-02-15', 'lastUpdatePostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood-Brain-Barrier Permeability after 10-14days of cerebrolysin in patients with AIS of the middle cerebral artery', 'timeFrame': 'After 10-14 days of cerebrolysin', 'description': 'Blood-brain barrier (BBB) disruption will be measured using dynamic susceptibility contrast (DSC) magnetic resonance imaging (MRI).DSC MRI is collected during the injection of a gadolinium bolus and the majority of the change in recorded signal in this T2\\*-weighted sequence is due to intravascular contrast. However, in the setting of gadolinium leakage through the BBB into the brain parenchyma, the recorded signal is altered by a T1 effect. An arrival time correction is performed to account for regional difference in blood flow after which the signal is separated into an intravascular and an extravascular component using a comparison with unaffected tissue. The extravascular component is captured with the metric K2 which reflects the fraction of the recorded signal that is due to gadolinium leakage and is a measure of BBB disruption.'}], 'secondaryOutcomes': [{'measure': 'Comparison of clinical severity, using NIH Stroke Scale in patients with and withouth cerebrolysin', 'timeFrame': 'After 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge', 'description': 'The NIH Stroke Scale would be measured in all patients in the indicated time frames, and the results would be compared based among the 3 groups'}, {'measure': 'Comparison of functional prognosis, using modified Rankin scale in patients with and withouth cerebrolysin', 'timeFrame': 'After 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge', 'description': 'The modified Rankin scale would be measured in all patients in the indicated time frames, and the results would be compared based among the 3 groups'}, {'measure': 'Comparison of cognitive impairment, using Montreal Cognitive Assessment in patients with and withouth cerebrolysin', 'timeFrame': 'fter 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge', 'description': 'The Montreal Cognitive Assessment would be measured in all patients in the indicated time frames, and the results would be compared based among the 3 groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'diabetes mellitus type 2'], 'conditions': ['Ischemic Stroke, Acute', 'Diabetes Mellitus, Type 2', 'Blood Brain Barrier']}, 'descriptionModule': {'briefSummary': 'A prospective, single-center study would be carried out in the Neurology Department of the University Hospital "Dr. José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier in patients with ischemic stroke with personal history of type-2 diabetes', 'detailedDescription': 'A prospective, single-center study would be carried out in the Neurology Department of the University Hospital "Dr. José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier (BBB) in patients with ischemic stroke (IS) of the middle cerebral artery with personal history of type-2 diabetes (T2D).\n\nThe main objective is to compare the effect of cerebrolysin on the BBB in the above mentioned patients with intravenous thrombolysis (IVT) and without IVT.\n\nThe hypothesis of this study is that cerebrolysin can affect the BBB permeability after 10 days of the administration of this drug'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18 - 80 years.\n2. Clinical and imaging criteria for ischemic stroke of the middle cerebral artery.\n3. Acute non-lacunar cerebral infarction.\n4. Cerebral infarction with a score on the NIH scale between 5 and 20 points.\n5. Patient with a previous diagnosis of type 2 diabetes mellitus, regardless of the form of diagnosis, time of evolution, previous or current treatment, adherence or not to treatment, presence or absence of microvascular and/or macrovascular complications.\n6. mRs ≤ 1 before the qualifying stroke (functionally independent for all activities of daily living).\n7. The patient and/or legal representative or direct family member has signed the informed consent form.\n\nExclusion Criteria:\n\n1. Advanced disease or terminal with life expectancy \\< 6 months.\n2. \\- Over 80 years old\n3. Lacunar infarction or small vessel disease.\n4. Pre-existing medical, neurological, or psychiatric disease that would confound neurological or functional evaluations (eg, Alzheimer's disease, vascular dementia, Parkinson's disease, demyelinating disease, encephalopathy of any cause, history of significant alcohol or drug abuse).\n5. Pregnancy or lactation.\n6. Acute or chronic renal failure with creatinine clearance \\<30 mL/min.\n7. Allergy or any condition that represents a contraindication for the administration of Cerebrolysin.\n8. Treatment with another investigational drug within the past 30 days that may interfere with the study drug."}, 'identificationModule': {'nctId': 'NCT06273020', 'briefTitle': 'Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Dr. Jose E. Gonzalez'}, 'officialTitle': 'The Effect of Cerebrolysin on the Blood-brain-barrier in Patients With Diabetes and Ischemic Stroke', 'orgStudyIdInfo': {'id': 'MI22-00013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous thrombolysis and cerebrolysin', 'description': "Group 1: 20 patients with previous intravenous thrombolysis (IVT) in the qualifying stroke and who agreed to receive and got selected (through randomization) cerebrolysin.\n\nCerebrolysin would be prepared according to manufacturer's instructions: 30 mL of cerebrolysin in 100 ml of saline solution every 24 hours to a minimum of 10 days and a maximum of 14 days", 'interventionNames': ['Drug: Cerebrolysin', 'Procedure: Brain-MRI with contrast after 10-14 days of cerebrolysin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous thrombolysis without cerebrolysin', 'description': 'Group 2 : 20 patients with previous IVT in the qualifying stroke and who agreed to receive cerebrolysin but they were not choose through randomization.', 'interventionNames': ['Procedure: Brain-MRI with contrast after 10-14 days of cerebrolysin']}, {'type': 'OTHER', 'label': 'Patients with cerebrolysin without IVT', 'description': "Group 3: 20 patients that they were not candidates to receive IVT (out of therapeutic window) but agreed to receive cerebrolysin (randomization not used)\n\nCerebrolysin would be prepared according to manufacturer's instructions: 30 mL of cerebrolysin in 100 ml of saline solution every 24 hours to a minimum of 10 days and a maximum of 14 days", 'interventionNames': ['Drug: Cerebrolysin', 'Procedure: Brain-MRI with contrast after 10-14 days of cerebrolysin']}], 'interventions': [{'name': 'Cerebrolysin', 'type': 'DRUG', 'description': "Cerebrolysin would be prepared according to manufacturer's instructions: 30 mL of cerebrolysin in 100 ml of saline solution every 24 hours to a minimum of 10 days and a maximum of 14 days", 'armGroupLabels': ['Intravenous thrombolysis and cerebrolysin', 'Patients with cerebrolysin without IVT']}, {'name': 'Brain-MRI with contrast after 10-14 days of cerebrolysin', 'type': 'PROCEDURE', 'description': 'Blood-brain barrier (BBB) disruption will be measured using dynamic susceptibility contrast (DSC) magnetic resonance imaging. DSC MRI is collected during the injection of a gadolinium bolus and the majority of the change in recorded signal in this T2-weighted sequence is due to intravascular contrast. However, in the setting of gadolinium leakage through the BBB into the brain parenchyma, the recorded signal is altered by a T1 effect. An arrival time correction is performed to account for regional difference in blood flow after which the signal is separated into an intravascular and an extravascular component using a comparison with unaffected tissue.The extravascular component is captured with the metric K2 which reflects the fraction of the recorded signal that is due to gadolinium leakage and is a measure of BBB disruption.', 'armGroupLabels': ['Intravenous thrombolysis and cerebrolysin', 'Intravenous thrombolysis without cerebrolysin', 'Patients with cerebrolysin without IVT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64020', 'city': 'Nuevo León', 'state': 'Monterrey', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Servicio F de Neurología del Hospital Universitario "Dr.José E. González"', 'role': 'CONTACT', 'email': 'neurologiahu.posgrado@gmail.com', 'phone': '+528183591111'}, {'name': 'José C Becerra-Cruz, M.D.', 'role': 'CONTACT', 'email': 'becerracruz@hotmail.com', 'phone': '+522324393970'}], 'facility': 'Servicio de Neurología del Hospital Universitario "Dr.José E. González"', 'geoPoint': {'lat': 32.4095, 'lon': -115.18896}}], 'centralContacts': [{'name': 'Juan F Góngora-Rivera, Ph.D.', 'role': 'CONTACT', 'email': 'fernando.gongora@hotmail.com', 'phone': '+528115163257'}, {'name': 'Servicio de Neurología del Hospital Universitario "Dr.José E. González"', 'role': 'CONTACT', 'email': 'neurologiahu.posgrado@gmail.com', 'phone': '+528183591111'}], 'overallOfficials': [{'name': 'Juan F Góngora-Rivera, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Dr. Jose E. Gonzalez'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Anytime after the publication of this trial in an indexed journal', 'ipdSharing': 'YES', 'description': 'The individual participant data would be shared upon reasonable request after the publication of this trial in an indexed journal', 'accessCriteria': 'Design of meta-analysis When in doubt of the veracity of the data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Dr. Jose E. Gonzalez', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ever Neuro Pharma GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.med. Juan Fernando Góngora Rivera', 'investigatorFullName': 'Juan Fernando Góngora Rivera, MD, PhD', 'investigatorAffiliation': 'Hospital Universitario Dr. Jose E. Gonzalez'}}}}