About this trial
While the effectiveness of intravenous thrombolysis (IVT) decreases over time, patients show considerable variability in how quickly their ischemic core progresses. Quantitative net water uptake (NWU) has emerged as a biomarker indicating blood-brain barrier disruption and may better reflect the "tissue clock" than time alone. Low NWU is associated with favorable outcomes, whereas high NWU predicts poor outcomes and futile recanalization. The study aims to determine whether NWU measured on initial non-contrast CT is a treatment effect modifier for the IVT therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Acute ischemic stroke treated with intravenous thrombolysis
Imaging with non-contrast cranial CT on admission
Follow-up imaging with non-contrast cranial CT or MRI 12-24 hours after IVT
Final Infarct volume > 5ml
Disqualifiers
Known use of oral anticoagulation (OAC) on admission
Preexisting ischemic infarction on admission non-contrast cranial CT
Patients with large vessel occlusion AIS who underwent mechanical thrombectomy
Low imaging quality precluding radiological measurements
Trial population
Patients aged over 18 years with acute ischemic stroke, symptom onset within 24 hours prior to admission and treatment in one of the stroke units of the participating institutions between 2018 and 2025 treated using IVT and fullfilling inclusion criteria
Trial design
Cohort
Retrospective
Treatments tested in this trial
No Interventions
Other interventionNot applicable as this is an observational, retrospective study.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with functional independence (modified Rankin Scale score 0-1)
Functional independence defined as a modified Rankin Scale (mRS) score of 0-1 assessed at 90 days.
Secondary outcomes
Number of participants with symptomatic intracerebral hemorrhage
Symptomatic intracerebral hemorrhage (sICH) as defined by the European Cooperative Acute Stroke Study (ECASS) III criteria (i.e., an ICH associated with an increase of ≥4 points on the NIHSS or death where intracranial hemorrhage is the predominant cause of neurological deterioration).
Number of participants with intracerebral hemorrhage on follow-up brain imaging
Intracerebral hemorrhage detected on follow-up brain imaging performed within 24 hours after treatment.
Mortality
Sponsors and contacts
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