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

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 Overview

• Status: Not yet recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Other: No Interventions

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Marek Sykora; Phone Number: +431211215183; Email: marek.sykora@med.sfu.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with ischemic stroke receiving IVT	Other: No Interventions; Not applicable as this is an observational, retrospective study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		at 90 days
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).	at 24 hours
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.	at 24 hours

Collaborators and Investigators

• Sponsor: Sigmund Freud PrivatUniversitat

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Estimated): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 17803148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results after deidentification
• IPD Sharing Access Criteria: Data that support the findings of this study will be available from the corresponding author after academic board review and upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No