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

NCT06273020 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-02-22

No results posted yet for this study

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

Conditions

  • Ischemic Stroke, Acute
  • Diabetes Mellitus, Type 2
  • Blood 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.

Sponsors & Collaborators

  • Ever Neuro Pharma GmbH

    collaborator INDUSTRY

  • Hospital Universitario Dr. Jose E. Gonzalez

    lead OTHER

Principal Investigators

  • Juan F Góngora-Rivera, Ph.D. · Hospital Universitario Dr. Jose E. Gonzalez

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-17
Primary Completion
2024-11-30
Completion
2024-12-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06273020 on ClinicalTrials.gov