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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSigmund Freud PrivatUniversitat

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • No Interventions

    Other intervention

    Not applicable as this is an observational, retrospective study.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: patients with ischemic stroke receiving IVT1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
at 90 days

Secondary outcomes

1

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).

Time frame
at 24 hours
2

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.

Time frame
at 24 hours
3

Mortality

Time frame
at 90 days

Other outcomes

Sponsors and contacts

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