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RecruitingNCT05864495e-StrokeUpdated Jul 17, 2023

Neuroimaging in Acute Stroke

An observational study in Stroke, Acute and Stroke, Ischemic, sponsored by University Hospital Ostrava. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-17.

Sponsored by University Hospital Ostrava · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

The main aim of this study is to identify the predictive value of CT parameters (e-ASPECTS, CTP, collateral vessel status, volume, and location of ischemic lesion volume) at a 3-month functional outcome defined by the modified Rankin scale (mRS) in patients with non-lacunar stroke after recanalization treatment (Intravenous Thrombolytic Therapy and/or Mechanical Thrombectomy, or conservative treatment).

Read the detailed description

This is a multicenter observational study of patients with acute ischemic non-lacunar stroke and premorbid mRS ≤ 4, who are treated with intravenous thrombolysis and/or endovascular thrombectomy (EVT) or conservatively in stroke centers that are part of the National Stroke Research Network (STROCZECH).

All patients with suspected acute stroke routinely undergo baseline non-contrast computer tomography (NCCT) and single-phase CT-angiography (CTA) from the aortic arch to the vertex. Follow-up neuroimaging includes NCCT (a standard of care in the Czech Republic) up to 36 hours after endovascular therapy (EVT) or intravenous thrombolysis (IVT) treatment. The optimal timing of follow-up imaging > 24 hours is chosen since it represents the earliest time point for accurate delineation of acute ischemia volume.

NCCT will be performed on a multi-detector spiral 64 series CT machine. The NCCT examination is followed by CTA using 50-100 ml of iodine conjugate (Visipaque, GE Healthcare, Piscataway, NJ, USA), which is administered at a rate of 4 ml/s. The range of CTA is from the aortic arch to the distal intracranial artery. The width of the basic CT sections for further reconstruction is 0.75 mm.

Automated processing of NCCT, CTA, and CT perfusion (CTP) will be performed using the latest CE-marked version of e-Stroke software (Brainomix, Oxford, UK) at baseline, and follow-up imaging will be processed using algorithms in development by Brainomix.

The e-Stroke image processing algorithms follow an artificial intelligence (AI) approach with a combination of traditional 3D graphics and statistical methods, and machine learning classification techniques. The algorithms have been trained on a large dataset (> 10000 images) containing a wide range of real-world CT scans from stroke patients and negative controls with ground-truth data from additional imaging data such as MRI acquired within 1-2 hours of the CT scan, along with other modalities and clinical information. This dataset contains examples of CT scans captured with scanners from all major manufacturers, from a wide range of countries worldwide. Within e-Stroke NCCT, CTA and CTP will be processed using e-ASPECTS, e-CTA, and e-CTP modules respectively. It must be noted that e-Stroke is intended to be used as a decision support tool. Results are designed to be interpreted in the clinical context and radiological interpretation of the user.

Standardly acquired non-contrast CT, CTA, and CTP will be processed.

Within this project, imaging data from the e-STROKE system and clinical data stored in the RES-Q registry (REgistry of Stroke Care Quality) will be fused and subsequently analyzed. The RES-Q registry collects information related to hospital care for stroke patients, especially in the acute phase. Since 2021, the Ministry of Health of the Czech Republic has included RES-Q in the national policy as one of the indicators of stroke care. Therefore, the range of parameters assessed within this project will provide unique and potentially new information related to stroke that could impact the provision of non-hospital care in the future.

02

Conditions studied

  • Stroke, Acute
  • Stroke, Ischemic

Keywords

  • stroke
  • neuroimaging
  • e-ASPECTS
  • Brainomix
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 500 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University Hospital Ostrava is the lead sponsor of 146 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutively admitted patients with ischemic stroke over the age of 18.

Inclusion criteria

  • Acute ischemic stroke within 12 hours of onset, treated with intravenous thrombolysis and/or mechanical thrombectomy or conservatively.
  • Unknown time of onset of ischemic stroke.
  • Wake-up stroke (with symptoms of stroke since awakening).

Exclusion criteria

Exclusion Criteria:

  • Pre-event modified Rankin Scale (mRS) score > 4 points.
  • Acute haemorrhagia or other NCCT finding excluding dg. ischemic stroke.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Modified Rankin Scale

    To find the predictive value of CT parameters (e-ASPECTS, CTP (CTP provides absolute and relative information about brain perfusion parameters, namely cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT), and time to peak (TTP). MTT is the time between the arterial inflow and the venous outflow), collateral vessel status, volume and location of ischemic lesion volume) at a 3 month functional outcome defined by the modified Rankin scale (mRS) in patients with non-lacunar stroke after recanalization treatment (IVT and/or MT, or conservative therapy)

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • University Hospital Ostrava
    Ostrava, Moravian-Silesian Region 70852, Czechia
    • Jiří Hynčica · Contact · jiri.hyncica@fno.cz · 0042059737
    • Michal Bar, Assoc.Prof.,MD,Ph.D. · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — There is no plan to make individual participant data available to other researchers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05864495
Lead sponsor
University Hospital Ostrava
Collaborators
St. Anne's University Hospital Brno, Czech Republic, Na Homolce Hospital, General University Hospital, Prague, Pardubice Hospital, University Hospital Hradec Kralove, University Hospital, Motol, University Hospital Kralovske Vinohrady, Hospital Pisek, Vitkovice Hospital, České Budějovice Hospital, Jihlava Hospital, Brno University Hospital, Karvina Miners Hospital, Regional Hospital Liberec, Vyskov Hospital, Thomayer University Hospital, Municipal Hospital Ostrava, Regional Hospital Mlada Boleslav, Regional Hospital Pribram
Responsible party
Sponsor
First posted
May 18, 2023
Start date
May 1, 2023
Primary completion
Dec 2024 (estimated)
Completion
May 2025 (estimated)
Last update
Jul 17, 2023

Study contacts

Jiří Hynčica
Contact
jiri.hyncica@fno.cz
0042059737 ext. 2587
Michal Bar, Assoc.Prof.,MD,Ph.D.
principal investigator · University Hospital Ostrava

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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