Stroke, Acutee-StrokeNCT05864495
Neuroimaging in Acute Stroke
An observational study of Stroke, Acute and Stroke, Ischemic, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Stroke, Ischemic
- How many people
- 500 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2023to May 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Consecutively admitted patients with ischemic stroke over the age of 18.
Who may be able to join
- 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).
Who cannot join
- Pre-event modified Rankin Scale (mRS) score > 4 points.
- Acute haemorrhagia or other NCCT finding excluding dg. ischemic stroke.
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Michal Bar, Assoc.Prof.,MD,Ph.D.
About this study
Official title: Predictive Value of Brainomix Software CT Evaluation for Final Outcome in Patients With Acute Non-lacunar Stroke
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.
- Conditions
- Stroke, Acute, Stroke, Ischemic
- Keywords
- stroke, neuroimaging, e-ASPECTS, Brainomix
- Medical subject headings
- Stroke, Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 May 2023
- Primary completionDec 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic, Na Homolce Hospital, General University Hospital, Prague, Hospital Pardubice, University Hospital Hradec Kralove, University Hospital, Motol, Vascular surgery, University hospital Královské Vinohrady, Prague, 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
- Investigators
- Michal Bar, Assoc.Prof.,MD,Ph.D., Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864495
- Sponsor's protocol ID
- STRO_2023/05
- Acronym
- e-Stroke
- Status last verified
- Jul 2023
- First submitted
- 2 May 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Brainomix Software CT Evaluation for Final Outcome in Patients With Acute Non-lacunar Stroke
- ClinicalTrials.gov ID
- NCT05864495
- Acronym / sponsor ID
- e-Stroke / STRO_2023/05
- Conditions
- Stroke, Acute, Stroke, Ischemic
- Keywords
- stroke, neuroimaging, e-ASPECTS, Brainomix
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic, Na Homolce Hospital, General University Hospital, Prague, Hospital Pardubice, University Hospital Hradec Kralove, University Hospital, Motol, Vascular surgery, University hospital Královské Vinohrady, Prague, 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
- Study start
- 1 May 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 18 May 2023 (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.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutively admitted patients with ischemic stroke over the age of 18.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Pre-event modified Rankin Scale (mRS) score > 4 points.
- Acute haemorrhagia or other NCCT finding excluding dg. ischemic stroke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Rankin Scale
Time frame: 3 months
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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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. This study is not recruiting at the moment.
Michal Bar, Assoc.Prof.,MD,Ph.D. principal investigator
University Hospital Ostrava
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 Stroke, Acute and Stroke, Ischemic, run by University Hospital Ostrava at 1 site in Czechia.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Jul 2023. 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 Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (time frame: 3 months). 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 17 Jul 2023.