Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05864495 |
| Other study ID # |
STRO_2023/05 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2023 |
| Est. completion date |
May 2025 |
Study information
| Verified date |
July 2023 |
| Source |
University Hospital Ostrava |
| Contact |
Jirí Hyncica |
| Phone |
0042059737 |
| Email |
jiri.hyncica[@]fno.cz |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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 (Intravenous Thrombolytic Therapy and/or Mechanical
Thrombectomy, or conservative treatment).
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.
