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Recruiting NCT07299981

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

— Observational Ischemic Stroke Thrombolysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Interventions.
Who it may be relevant to
Registry conditions: Ischemic Stroke, Thrombolysis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other No Interventions
    Not applicable as this is an observational, retrospective study.

Primary outcome measures

  • Number of participants with functional independence (modified Rankin Scale score 0-1) [Time frame: at 90 days]
Secondary outcome measures (3)
  • Number of participants with symptomatic intracerebral hemorrhage [Time frame: at 24 hours]
  • Number of participants with intracerebral hemorrhage on follow-up brain imaging [Time frame: at 24 hours]
  • Mortality [Time frame: at 90 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Austria · 1 center
  • Department of Neurology, St. John's Hospital, Vienna, Austria, Vienna, 1020 — Vienna

Identifiers

NCT: NCT07299981 · 17803148

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗