e-Stroke: Neuroimaging in Acute Stroke

Sponsor

University Hospital Ostrava (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05864495

Collaborator

St. Anne's University Hospital Brno, Czech Republic (Other), Na Homolce Hospital (Other), General University Hospital, Prague (Other), Pardubice Hospital (Other), University Hospital Hradec Kralove (Other), University Hospital, Motol (Other), University Hospital Kralovske Vinohrady (Other), Hospital Pisek (Other), Vitkovice Hospital (Other), České Budějovice Hospital (Other), Jihlava Hospital (Other), Brno University Hospital (Other), Karvina Miners Hospital (Other), Regional Hospital Liberec (Other), Vyskov Hospital (Other), Thomayer University Hospital (Other), Municipal Hospital Ostrava (Other), Regional Hospital Mlada Boleslav (Other), Regional Hospital Pribram (Other)

500

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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 Thrombolitic Therapy and/or Mechanical Thrombectomy, or conservative treatment).

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute Stroke, Ischemic

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 NCCT and single-phase 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 the EVT or 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 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 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 analysed. 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. Therefor, the range of parameters assessed within this project will provide unique and potentially new information related to stroke that could impact on the provision of non-hospital care in the future.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Predictive Value of Brainomix Software CT Evaluation for Final Outcome in Patients With Acute Non-lacunar Stroke

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

May 1, 2025

Outcome Measures

Primary Outcome Measures

Modified Rankin Scale [3 months]
To find 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 (IVT and/or MT, or conservative therapy)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

Contacts and Locations

Locations

No locations specified.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Ostrava

ClinicalTrials.gov Identifier:

NCT05864495

Other Study ID Numbers:

STRO_2023/05

First Posted:

May 18, 2023

Last Update Posted:

May 18, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital Ostrava

Additional relevant MeSH terms:

Stroke

Ischemic Stroke

Study Results

No Results Posted as of May 18, 2023