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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07299981
Enrollment
200
Registered
2025-12-23
Start date
2026-02-01
Completion date
2027-07-01
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke, Thrombolysis

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.

Interventions

OTHERNo Interventions

Not applicable as this is an observational, retrospective study.

Sponsors

Sigmund Freud PrivatUniversitat
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with functional independence (modified Rankin Scale score 0-1)at 90 daysFunctional independence defined as a modified Rankin Scale (mRS) score of 0-1 assessed at 90 days.

Secondary

MeasureTime frameDescription
Number of participants with symptomatic intracerebral hemorrhageat 24 hoursSymptomatic 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 imagingat 24 hoursIntracerebral hemorrhage detected on follow-up brain imaging performed within 24 hours after treatment.
Mortalityat 90 days

Countries

Austria

Contacts

CONTACTMarek Sykora
marek.sykora@med.sfu.ac.at+431211215183

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026