Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke
NCT ID: NCT06273020
Last Updated: 2024-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2022-11-17
2024-12-31
Brief Summary
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Detailed Description
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The main objective is to compare the effect of cerebrolysin on the BBB in the above mentioned patients with intravenous thrombolysis (IVT) and without IVT.
The hypothesis of this study is that cerebrolysin can affect the BBB permeability after 10 days of the administration of this drug
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Group 1: 20 patients with previous intravenous thrombolysis (IVT) in the qualifying stroke and who agreed to receive and got selected (through randomization) cerebrolysin.
Group 2 : 20 patients with previous IVT in the qualifying stroke and who agreed to receive cerebrolysin but they were not choose through randomization.
Group 3: 20 patients that they were not candidates to receive IVT (out of therapeutic window) but agreed to receive cerebrolysin (randomization not used)
SUPPORTIVE_CARE
NONE
Study Groups
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Intravenous thrombolysis and cerebrolysin
Group 1: 20 patients with previous intravenous thrombolysis (IVT) in the qualifying stroke and who agreed to receive and got selected (through randomization) cerebrolysin.
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
Cerebrolysin
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
Brain-MRI with contrast after 10-14 days of cerebrolysin
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.
Intravenous thrombolysis without cerebrolysin
Group 2 : 20 patients with previous IVT in the qualifying stroke and who agreed to receive cerebrolysin but they were not choose through randomization.
Brain-MRI with contrast after 10-14 days of cerebrolysin
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.
Patients with cerebrolysin without IVT
Group 3: 20 patients that they were not candidates to receive IVT (out of therapeutic window) but agreed to receive cerebrolysin (randomization not used)
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
Cerebrolysin
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
Brain-MRI with contrast after 10-14 days of cerebrolysin
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.
Interventions
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Cerebrolysin
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
Brain-MRI with contrast after 10-14 days of cerebrolysin
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.
Eligibility Criteria
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Inclusion Criteria
2. Clinical and imaging criteria for ischemic stroke of the middle cerebral artery.
3. Acute non-lacunar cerebral infarction.
4. Cerebral infarction with a score on the NIH scale between 5 and 20 points.
5. 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.
6. mRs ≤ 1 before the qualifying stroke (functionally independent for all activities of daily living).
7. The patient and/or legal representative or direct family member has signed the informed consent form.
Exclusion Criteria
2. \- Over 80 years old
3. Lacunar infarction or small vessel disease.
4. 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).
5. Pregnancy or lactation.
6. Acute or chronic renal failure with creatinine clearance \<30 mL/min.
7. Allergy or any condition that represents a contraindication for the administration of Cerebrolysin.
8. Treatment with another investigational drug within the past 30 days that may interfere with the study drug.
18 Years
80 Years
ALL
No
Sponsors
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Ever Neuro Pharma GmbH
INDUSTRY
Hospital Universitario Dr. Jose E. Gonzalez
OTHER
Responsible Party
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Juan Fernando Góngora Rivera, MD, PhD
Dr.med. Juan Fernando Góngora Rivera
Principal Investigators
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Juan F Góngora-Rivera, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Dr. Jose E. Gonzalez
Locations
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Servicio de Neurología del Hospital Universitario "Dr.José E. González"
Nuevo León, Monterrey, Mexico
Countries
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Central Contacts
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Servicio de Neurología del Hospital Universitario "Dr.José E. González"
Role: CONTACT
Facility Contacts
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Servicio F de Neurología del Hospital Universitario "Dr.José E. González"
Role: primary
Other Identifiers
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MI22-00013
Identifier Type: -
Identifier Source: org_study_id
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