Automatically quantified follow-up imaging biomarkers predict clinical outcomes after acute ischemic stroke

Area of Science:

• Neurology
• Radiology
• Medical Imaging

Background:

• Follow-up infarct volume (FIV) is a proposed surrogate endpoint for acute ischemic stroke (AIS) clinical studies.
• Clinical validation of an automated FIV algorithm is crucial for its adoption in trials.

Purpose of the Study:

• To clinically validate an automated FIV algorithm for acute ischemic stroke (AIS).
• To demonstrate the association between imaging biomarkers and clinical outcomes in AIS patients.
• To support the use of imaging endpoints in clinical trials for AIS.

Main Methods:

• Adult AIS patients undergoing mechanical thrombectomy were included.
• Follow-up imaging was performed 12-96 hours post-assessment.
• Automated software quantified total FIV and components: cFIV, hemorrhagic transformation (HT), anatomical distortion (AD), and infarct growth (IG).
• Clinical outcomes assessed were modified Rankin Scale (mRS) at 90 days and NIH Stroke Scale (NIHSS) at 24 hours.

Main Results:

• 843 patients were analyzed; median age 72 years.
• FIV was significantly associated with 90-day mRS (concordance=0.819) and 24-hour NIHSS (concordance=0.722).
• cFIV, HT, AD, and IG also showed significant associations with clinical outcomes.
• Multivariate analysis confirmed FIV's strong association with 90-day mRS.

Conclusions:

• Automated FIV is strongly associated with clinical outcomes in AIS patients.
• FIV and its components (ischemic injury, HT, edema, IG) serve as significant prognostic imaging biomarkers.
• This study validates FIV as a mechanistic endpoint for early-stage AIS therapeutic trials.