Quantitative Net Water Uptake as a Predictor of Functional Outcomes After Intravenous Thrombolysis in Acute Ischemic Stroke International Multicenter Observational Retrospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Functional independence
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •ASPECTS available
Exclusion Criteria
- •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
- •Severe white matter lesions precluding radiological measurements
- •No ASPECTS
Arms & Interventions
patients with ischemic stroke receiving IVT
Intervention: No Interventions (Other)
Outcomes
Primary Outcomes
Functional independence
Time Frame: at 90 days
modified Rankin Scale of 0-1
Number of participants with functional independence (modified Rankin Scale score 0-1)
Time Frame: at 90 days
Functional independence defined as a modified Rankin Scale (mRS) score of 0-1 assessed at 90 days.
Secondary Outcomes
- Intracerebral hemorrhage(at 24 hours)
- Mortality(at 90 days)
- Symptomatic intracerebral hemorrhage(at 24 hours)
- Number of participants with symptomatic intracerebral hemorrhage(at 24 hours)
- Number of participants with intracerebral hemorrhage on follow-up brain imaging(at 24 hours)