BACKGROUND: Follow-up infarct volume (FIV) is a proposed surrogate endpoint for proof-of-concept clinical studies in acute ischemic stroke (AIS). This study aimed to provide clinical validation of an automated FIV algorithm, demonstrating the association of imaging biomarkers with clinical outcomes to support the use of these imaging endpoints in clinical trials. METHODS: Data were gathered for adult AIS patients undergoing mechanical thrombectomy with follow-up imaging 12-96 h from initial assessment. Non-contrast computed tomography was used to quantify infarct volume. Image processing used the AI-powered software Brainomix 360 Stroke (Brainomix Ltd., Oxford, United Kingdom) and Brainomix core lab research software. Measures included total FIV and components-ischemic injury corrected FIV (cFIV), hemorrhagic transformation (HT), anatomical distortion (AD; a marker of edema) and infarct growth (IG). The primary clinical endpoint was modified Rankin Scale (mRS) at 90 days; secondary clinical endpoint was NIH Stroke Scale (NIHSS) score at 24 h. RESULTS: Of 986 patients, 843 (85.5%; median age 72 years, 56.7% male) had complete data and were included in the study analysis. Median baseline NIHSS score was 17 (IQR: 12-21). Median imaging follow-up time was 24 h (IQR 20-28). Median 24 h NIHSS score was 11 (5-17); 34% of patients had mRS 0-2 at 90 days. Median FIV was 30.2 mL (12.5-120.8 mL). FIV was significantly associated with 90-day mRS (concordance = 0.819, p < 0.001) and NIHSS at 24 h (concordance = 0.722, p < 0.001). cFIV, HT, AD, and IG were also significantly associated with good clinical outcomes in both 90-day mRS (concordance = 0.702, p < 0.001; 0.660, p < 0.001; 0.591, p = 0.002; and 0.663, p < 0.001, respectively) and NIHSS at 24 h (0.774, p < 0.001; 0.652, p = 0.004 L; 0.694, p < 0.001; and 0.716, p < 0.001, respectively). In multivariate analysis, FIV remained strongly associated with 90-day mRS. FIV showed a bimodal distribution consistent with success/failure of recanalization during thrombectomy. CONCLUSION: Of the algorithm outputs assessed, FIV was most strongly associated with clinical outcomes. Ischemic injury, HT, edema and IG were also independently significantly associated with clinical outcome. This study validates the prognostic significance of automated FIV and its composites as mechanistic endpoints to improve early-stage trials of therapeutics in AIS.

• Klíčová slova
• artificial intelligence, follow-up studies, imaging, ischemic stroke, neuroimaging, thrombectomy,
• Publikační typ
• časopisecké články MeSH

Introduction: The e-STROKE study is a prospective, multicenter observational study designed to assess the impact of various CT parameters (including e-ASPECT, CT perfusion (CTP), collateral flow status, and the size and location of the ischemic lesion) on the clinical outcomes of patients with ischemic stroke, as evaluated by the modified Rankins Scale (mRS) three months post-stroke. This study also aims to investigate whether the use of multimodal CT imaging increases the number of patients eligible for recanalization therapy. The analysis will integrate data from the RES-Q registry and radiological data from the e-STROKE system provided by Brainomix Ltd. Aims: The primary aim is to determine the predictive value of CT parameters (e-ASPECTS, CTP, collateral vessel status, and ischemic lesion volume and location) on three-month functional outcomes, as defined by the mRS, in patients with non-lacunar stroke following recanalization treatment (IVT and/or MT). The secondary aim is to evaluate whether multimodal CT examination leads to an increase in the number of patients eligible for recanalization therapy. Additionally, this study seeks to assess the specificity and sensitivity of multimodal CT in distinguishing stroke mimics from actual strokes. Methods: This multicenter observational study involves patients with suspected acute ischemic stroke and a premorbid mRS ≤ 4, who are treated with endovascular thrombectomy (EVT), intravenous thrombolysis (IVT), or managed conservatively in stroke centers within the Czech Stroke Research Network (STROCZECH), which is part of the Czech Clinical Research Infrastructure Network (CZECRIN). Data collection includes demographic, clinical, and imaging data variables such as age, sex, ethnicity, risk factors, treatment times (OTT, DNT, and OGT), TICI scores, post-treatment hemorrhage (ECAS II), mRS outcome, stroke etiology, e-ASPECTS, acute ischemic volume (AIV), thrombus length on NCCT, CTA collateral score and collateral vessel density, location of large vessel occlusion, ischemic core, hypoperfusion volume, mismatch ratio and volume, final infarct volume, hemorrhage volume, and MRI in case of negative follow-up NCCT. Conclusions: We anticipate collecting robust clinical and radiological data from approximately 2000 patients across 22 centers over a 12-month period. The results are expected to enhance the precision of diagnostic and prognostic radiological markers in managing acute stroke.

• Klíčová slova
• CT imaging, CT perfusion, multimodal CT, predictive value, stroke, stroke mimics,
• Publikační typ
• časopisecké články MeSH