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NCT Number: NCT07299981

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Thrombolysis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No interventions

Other

Not applicable as this is an observational, retrospective study.

Primary outcomes

  1. Number of participants with functional independence (modified Rankin Scale score 0-1)

    Time frame: at 90 days

    Functional independence defined as a modified Rankin Scale (mRS) score of 0-1 assessed at 90 days.

Secondary outcomes

  1. Number of participants with symptomatic intracerebral hemorrhage

    Time frame: at 24 hours

    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).

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

    Time frame: at 24 hours

    Intracerebral hemorrhage detected on follow-up brain imaging performed within 24 hours after treatment.

  3. Mortality

    Time frame: at 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Marek Sykora

CONTACT

[email protected]

+431211215183

Sponsors and collaborators

Lead sponsor

Sigmund Freud PrivatUniversitat

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 23, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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