Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke

PHASE4RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 17, 2022

Primary Completion Date

November 30, 2024

Study Completion Date

December 31, 2024

Conditions
Ischemic Stroke, AcuteDiabetes Mellitus, Type 2Blood Brain Barrier
Interventions
DRUG

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

PROCEDURE

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.

Trial Locations (1)

64020

RECRUITING

"Servicio de Neurología del Hospital Universitario Dr.José E. González", Nuevo León

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Ever Neuro Pharma GmbH

INDUSTRY

lead

Hospital Universitario Dr. Jose E. Gonzalez

OTHER

NCT06273020 - Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke | Biotech Hunter | Biotech Hunter