An observational study in Stroke, sponsored by Istituti Clinici Scientifici Maugeri SpA. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-21.
Sponsored by Istituti Clinici Scientifici Maugeri SpA · Observational
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.
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:
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 135 is below the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →Istituti Clinici Scientifici Maugeri SpA is the lead sponsor of 113 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with minor/moderate/severe stroke
Exclusion Criteria:
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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 54 months
Biomarker curve trend
Estimation of the impact of rehabilitation treatment on the trend of the biomarker curve in patients with ischemic stroke, i.e. how GFAP changes in time after treatment (comparison of GFAP levels between times)
Time frame: 54 months
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Istituti Clinici Scientifici Maugeri SpA