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Clinical Trials/NCT07299981
NCT07299981
Not yet recruiting
Not Applicable

Quantitative Net Water Uptake as a Predictor of Functional Outcomes After Intravenous Thrombolysis in Acute Ischemic Stroke International Multicenter Observational Retrospective Study

Sigmund Freud PrivatUniversitat0 sites200 target enrollmentStarted: January 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Sigmund Freud PrivatUniversitat
Enrollment
200
Primary Endpoint
Functional independence

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

Outcomes

Primary Outcomes

Functional independence

Time Frame: at 90 days

modified Rankin Scale of 0-1

Secondary Outcomes

  • Intracerebral hemorrhage(at 24 hours)
  • Mortality(at 90 days)
  • Symptomatic intracerebral hemorrhage(at 24 hours)

Investigators

Sponsor
Sigmund Freud PrivatUniversitat
Sponsor Class
Other
Responsible Party
Sponsor

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