| Trial ID: | L1839 |
| Source ID: | NCT06273020
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| Associated Drug: |
Cerebrolysin
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| Title: |
Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke
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| Acronym: |
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| Status: |
RECRUITING
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| Study Results: |
NO
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| Results: |
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| Conditions: |
Ischemic Stroke, Acute|Diabetes Mellitus, Type 2|Blood Brain Barrier
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| Interventions: |
DRUG: Cerebrolysin|PROCEDURE: Brain-MRI with contrast after 10-14 days of cerebrolysin
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| Outcome Measures: |
Primary: 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: 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, 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, 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, fter 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge
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| Sponsor/Collaborators: |
Sponsor: Hospital Universitario Dr. Jose E. Gonzalez | Collaborators: Ever Neuro Pharma GmbH
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
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| Enrollment: |
60
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
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| Start Date: |
2022-11-17
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| Completion Date: |
2024-12
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| Results First Posted: |
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| Last Update Posted: |
2024-02-22
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| Locations: |
Servicio de Neurología del Hospital Universitario "Dr.José E. González", Nuevo León, Monterrey, 64020, Mexico
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| URL: |
https://clinicaltrials.gov/show/NCT06273020
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