Ischemic StrokeNCT07299981
Quantitative Net Water Uptake as a Predictor of Functional Outcomes After Intravenous Thrombolysis in Acute Ischemic Stroke International Multicenter Observational Retrospective Study
An observational study of Ischemic Stroke and Thrombolysis, run by Sigmund Freud PrivatUniversitat at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Thrombolysis
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2026to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department of Neurology, St. John's Hospital, Vienna, Austria, Vienna, 1020
Vienna, 1020
Lisa Kaindl, Dr., 0043 21 211 3240, lisa.kaindl@bbwien.at
Marek Sykora, Prof.Dr., 0043 21 211 3240, marek.sykora@med.sfu.ac.at
About this 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.
- Conditions
- Ischemic Stroke, Thrombolysis
- Being tested
- No Interventions
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
Not applicable as this is an observational, retrospective study.
| Study group | Role | What they receive |
|---|---|---|
| patients with ischemic stroke receiving IVT | Not described Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 90 days
Secondary outcomes (3)
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).
Measured: 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.
Measured: at 24 hours
Mortality
Measured: at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Feb 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sigmund Freud PrivatUniversitat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299981
- Sponsor's protocol ID
- 17803148
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Net Water Uptake as a Predictor of Functional Outcomes After Intravenous Thrombolysis in Acute Ischemic Stroke International Multicenter Observational Retrospective Study
- ClinicalTrials.gov ID
- NCT07299981
- Acronym / sponsor ID
- 17803148
- Conditions
- Ischemic Stroke, Thrombolysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sigmund Freud PrivatUniversitatUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with ischemic stroke receiving IVT | – | Other: No Interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionsNot applicable as this is an observational, retrospective study. | Other | patients with ischemic stroke receiving IVT |
Primary outcome
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.
3 secondary outcomes
Number of participants with symptomatic intracerebral hemorrhage
Time frame: at 24 hours
Number of participants with intracerebral hemorrhage on follow-up brain imaging
Time frame: at 24 hours
Mortality
Time frame: at 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Thrombolysis, run by Sigmund Freud PrivatUniversitat at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marek Sykora (+431211215183, marek.sykora@med.sfu.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with functional independence (modified Rankin Scale score 0-1) (time frame: at 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.