Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke
The Effect of Cerebrolysin on the Blood-brain-barrier in Patients With Diabetes and Ischemic Stroke
1 other identifier
interventional
60
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2022
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 17, 2022
CompletedFirst Submitted
Initial submission to the registry
February 15, 2024
CompletedFirst Posted
Study publicly available on registry
February 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedFebruary 22, 2024
February 1, 2024
2 years
February 15, 2024
February 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood-Brain-Barrier Permeability after 10-14days of cerebrolysin in patients with AIS of the middle cerebral artery
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.
After 10-14 days of cerebrolysin
Secondary Outcomes (3)
Comparison of clinical severity, using NIH Stroke Scale in patients with and withouth cerebrolysin
After 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge
Comparison of functional prognosis, using modified Rankin scale in patients with and withouth cerebrolysin
After 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge
Comparison of cognitive impairment, using Montreal Cognitive Assessment in patients with and withouth cerebrolysin
fter 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge
Study Arms (3)
Intravenous thrombolysis and cerebrolysin
EXPERIMENTALGroup 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
Intravenous thrombolysis without cerebrolysin
ACTIVE COMPARATORGroup 2 : 20 patients with previous IVT in the qualifying stroke and who agreed to receive cerebrolysin but they were not choose through randomization.
Patients with cerebrolysin without IVT
OTHERGroup 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
Interventions
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
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
You may qualify if:
- Age 18 - 80 years.
- Clinical and imaging criteria for ischemic stroke of the middle cerebral artery.
- Acute non-lacunar cerebral infarction.
- Cerebral infarction with a score on the NIH scale between 5 and 20 points.
- 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.
- mRs ≤ 1 before the qualifying stroke (functionally independent for all activities of daily living).
- The patient and/or legal representative or direct family member has signed the informed consent form.
You may not qualify if:
- Advanced disease or terminal with life expectancy \< 6 months.
- \- Over 80 years old
- Lacunar infarction or small vessel disease.
- 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).
- Pregnancy or lactation.
- Acute or chronic renal failure with creatinine clearance \<30 mL/min.
- Allergy or any condition that represents a contraindication for the administration of Cerebrolysin.
- Treatment with another investigational drug within the past 30 days that may interfere with the study drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Servicio de Neurología del Hospital Universitario "Dr.José E. González"
Nuevo León, Monterrey, 64020, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan F Góngora-Rivera, Ph.D.
Hospital Universitario Dr. Jose E. Gonzalez
Central Study Contacts
Servicio de Neurología del Hospital Universitario "Dr.José E. González"
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.med. Juan Fernando Góngora Rivera
Study Record Dates
First Submitted
February 15, 2024
First Posted
February 22, 2024
Study Start
November 17, 2022
Primary Completion
November 1, 2024
Study Completion
December 1, 2024
Last Updated
February 22, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Anytime after the publication of this trial in an indexed journal
- Access Criteria
- Design of meta-analysis When in doubt of the veracity of the data
The individual participant data would be shared upon reasonable request after the publication of this trial in an indexed journal