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
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). 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
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.
Servicio de Neurología del Hospital Universitario "Dr.José E. González"
Nuevo León, Monterrey, Mexico
RECRUITINGBlood-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.
Time frame: After 10-14 days of cerebrolysin
Comparison of clinical severity, using NIH Stroke Scale in patients with and withouth cerebrolysin
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
Time frame: 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
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
Time frame: 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
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
Servicio de Neurología del Hospital Universitario "Dr.José E. González"
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Time frame: fter 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge