Monitoring of the Ischemic Stroke Patient Through the Use of New Serum Biomarkers and MRI Imaging

NCT05812846 | Completed

• 1 other identifier: 2250
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this study will be the evaluation (by ELISA quantification and quantitative RT-PCR) of circulating biomarkers of damage and regeneration in patients affected by ischemic stroke. The biomarker levels will be measured from the acute event (48h) and in subsequent 4 times (7 days, 30 days, 90 days, 180 days) following hospitalization, up to 6 months after the acute event. These data will then be correlated for all five times with the clinical scales normally used for patient evaluation and will also be associated with MRI-DTI measurements performed in the post-acute (30 days) and post-discharge (180 days) phase.

Conditions

Stroke

Keywords

stroke; biomarkers

Outcome Measures

Primary Outcomes (6)

• Circulating/neuroimaging biomarkers and GCS

  Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by Glasgow Coma Scale (GCS)

  54 months

• Circulating/neuroimaging biomarkers and NIHSS

  Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by NIHSS scale

  54 months

• Circulating/neuroimaging biomarkers and mRS

  Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by modified Rankin Scale (mRS)

  54 months

• Circulating/neuroimaging biomarkers and Functional Ambulation Classification

  Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by Functional Ambulation Classification

  54 months

• Circulating/neuroimaging biomarkers and Ashworth scale

  Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by Ashworth scale

  54 months

• Circulating/neuroimaging biomarkers and MMSE

  Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by MMSE scale

  54 months

Secondary Outcomes (1)

• Biomarker curve trend

  54 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with minor/moderate/severe stroke

You may qualify if:

• First occurrence of brain injury, confirmed on CT imaging, determined by ischemic stroke
• Patient able to sign an informed consent, alternatively legal representative or relative

You may not qualify if:

• Previous ischemic events
• Previous head trauma of any entity
• New onset of acute events during the study
• Previous illness, diagnosis or suspicion of current illness with central nervous system involvement
• Diagnosis of cognitive impairment prior to the acute event (MMSE \< 24)
• Need for walking assistance prior to the acute event
• Diagnosis of autoimmune diseases
• Diagnosis of haematological or oncological disease
• Diagnosis of a psychiatric condition: bipolar disorder, psychosis, schizophrenia or suicidal ideation
• Subjects with relative and absolute contraindications to magnetic resonance imaging.
• Life expectancy less than 1 year
• Dependence or abuse of alcohol, drugs or psychotropics prior to the acute event
• Pregnancy in progress
• Severe renal or hepatic insufficiency (Renal disease \> II stage, Child-Plugh score \>5)

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 14, 2023
• Study Start: December 4, 2018
• Primary Completion: June 3, 2023
• Study Completion: June 3, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-03

Locations

IT (1)