Clinical trial NCT05812846: Monitoring of the Ischemic Stroke Patient Through the Use of New Serum Biomarkers and MRI Imaging
Official title: Monitoring of the Ischemic Stroke Patient Through the Use of New Serum Biomarkers and MRI Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke
biomarkers
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with minor/moderate/severe stroke

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.

Detailed description: In current clinical practice, outcome's assessment after stroke and patients' monitoring during rehabilitation rely on scores in clinical scales and instrumental evaluations (electrophysiological evaluations and MRI imaging). This approach follows current guidelines but has some limitations:

* subjectivity of the patient's clinical evaluation and instrumental data's interpretation
* poor prognostic value of clinical scales;
* poor prognostic value of instrumental measurements;
* difficulty in standardizing and automating clinical/instrumental assessments;
* difficulty in evaluating medical services on a large scale due to the lack of discrete values of treatment efficacy.

The identification and validation of reliable and accessible biomarkers associated with patients' functional recovery could improve their care but still remains a clinical challenge.

Aim of this study will be to measure the levels of circulating biomarkers of brain damage and regeneration in patients affected by ischemic stroke, and to evaluate their prognostic relevance over a 6-month follow-up. Biomarkers' levels will be measured by ELISA and quantitative RT-PCR from the acute event (within 24h from symptoms onset) and in subsequent 4 time-points (7 days, 30 days, 90 days, 180 days post-stroke). Obtained data will be correlated with clinical scales used for patient evaluation and will be associated with MRI-DTI measurements performed in the post-acute (30 days) and post-discharge (180 days) phase.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Circulating/neuroimaging biomarkers and GCS
timeFrame: 54 months
measure: Circulating/neuroimaging biomarkers and NIHSS
timeFrame: 54 months
measure: Circulating/neuroimaging biomarkers and mRS
timeFrame: 54 months
measure: Circulating/neuroimaging biomarkers and Functional Ambulation Classification
timeFrame: 54 months
measure: Circulating/neuroimaging biomarkers and Ashworth scale
timeFrame: 54 months
measure: Circulating/neuroimaging biomarkers and MMSE
timeFrame: 54 months
Secondary outcomes:
measure: Biomarker curve trend
timeFrame: 54 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri SpA
state: Lombardia
Study officials:
References: