NCT05812846

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 135 (actual)
• Sponsor: Istituti Clinici Scientifici Maugeri SpA · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Timeline

• Start date: 2018-12-04
• Primary completion: 2023-06-03
• Completion: 2023-06-03
• First posted: 2023-04-14
• Last updated: 2023-07-21

Locations

1 site across 1 country: Italy