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

NCT07299981 | Not Yet Recruiting DMC

• 1 other identifier: 17803148
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ischemic Stroke

Outcome Measures

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.

  at 90 days

Secondary Outcomes (3)

• Number of participants with symptomatic intracerebral hemorrhage

  at 24 hours

• Number of participants with intracerebral hemorrhage on follow-up brain imaging

  at 24 hours

• Mortality

  at 90 days

Study Arms (1)

patients with ischemic stroke receiving IVT

Other: No Interventions

Interventions

No Interventions OTHER

Not applicable as this is an observational, retrospective study.

patients with ischemic stroke receiving IVT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sigmund Freud PrivatUniversitat: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Marek Sykora

CONTACT

+431211215183; marek.sykora@med.sfu.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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