Multimodal CT Examination in Stroke Mimics Diagnosis

Study Overview
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Brief Summary
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The proposed project is a multicentre prospective observational clinical research focused on refining multimodal computer tomography (CT) diagnostics in stroke mimics. The main aim is to accurately identify SM in order to minimize the risk of receiving inappropriate treatment and possible development of complications, which can have a negative impact on the patient´s health. The project includes an analysis of pharmacoeconomic parameters. It will examine saved costs in the case of non-administration of unindicated treatment and it will compare the number of adverse events related to the administration of unindicated treatment in patients diagnosed with SM.

Detailed Description
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The project has been designed as a prospective multicentre observational clinical research with applied outcomes leading to an improved provision of healthcare and healthcare costs. All patients older than 18 years admitted with suspected stroke will be included in the project. The project will be implemented in 2 hospitals in the Czech Republic, namely the University Hospital in Ostrava and the Hospital in České Budějovice. The analyses will be performed at the University of Ostrava. The primary objective of the project is to refine hospital diagnostics through the use of multimodal brain imaging (non-contrast CT (NCCT), CT angiography (CTA), and CT perfusion (CTP)) at hospital admission. The expected difference is at least 10% more patients with SM in the group diagnosed by the multimodal CT examination when compared to the group diagnosed with NCCT or NCCT/CTA. The primary objective is to demonstrate the specificity and sensitivity of multimodal brain imaging (NCCT, CTA, and CTP) when compared to the use of NCCT or NCCT/CTA in the acute diagnostics of SM in patients with a sudden focal neurological deficit (minimum 1 point on the National Institutes of Health Stroke Scale - NIHSS) within 24 hours from the onset of symptoms. In addition to the importance of CTP in the diagnosis of stroke mimics, we will also analyze the significance of other clinical data. The secondary objective is to compare the economic indicators and costs that will be saved by not providing inadequate treatment to patients with SM.

Official Title
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The Importance of Multimodal CT Examination in Stroke Mimics Diagnosis: a Prospective Observational Multicenter Study

Conditions
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Stroke Mimics

Intervention / Treatment
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* Diagnostic Test: Multimodal brain CT
* Diagnostic Test: Magnetic resonance imaging (MRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - an acute focal neurological deficit (minimum 1 point on the National Institutes of Health Stroke Scale - NIHSS) within 24 hours from the onset of symptoms Exclusion Criteria: the last period of normality is unknown prior to multimodal CT examination the last period of normality is >24 hours prior to multimodal CT examination the diagnostic evaluation is incomplete a final neurologic diagnosis cannot be determined

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with neurological deficits (stroke or SM)<br>All patients with acute neurological deficits (stroke or SM) will undergo neuroimaging diagnostic procedures initial multimodal brain CT (NCCT, CTP, CTA); then the follow-up NCCT within 24-36 hours. All patients without a confirmed concordant hypoperfusion or cerebral ischemia on their previous CT scans will undergo a magnetic resonance imaging (MRI) examination between the 3rd and 7th day after the admission to the hospital in order to confirm the diagnosis of SM. | Diagnostic Test: Multimodal brain CT<br>* Multimodal brain CT includes NCCT, CTP, and CTA<br>Diagnostic Test: Magnetic resonance imaging (MRI)<br>* MRI examination will be performed between the 3rd and 7th day after the admission to the hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of patients with SM | The primary objective is to demonstrate the specificity and sensitivity of multimodal brain imaging (NCCT, CTA and CTP) when compared to the use of NCCT or NCCT/CTA in the acute diagnostics of SM in patients with a sudden focal neurological deficit (minimum 1 point on the National Institutes of Health Stroke Scale - NIHSS) within 24 hours from the onset of symptoms. The difference will be measured in per cent (%) | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacoeconomic analysis | The pharmacoeconomic analysis will include a Health Technology Assessment (HTA) in order to calculate the potential value of an innovation at an early stage, analysing not only the quality of life of patients, but also the costs associated with the treatment of stroke and SM. The calculation of costs is based on the average cost of thrombolysis and its associated treatment, representing the incremental cost (IC). Economic evaluation is organised as a test of dominance of improved results (meaning less complications associated with the administration of thrombolysis) and lower costs. In order to calculate the overall benefit, the value of the Quality of Life and the specific parameter of the Quality Adjusted Life Year (QALY) set for the Czech Republic will be used. The results will be reported as expected incremental costs (IC) and effects (E) expressed in quality-adjusted years of life (QALY). | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke mimics, neurological disorders, cerebrovascular accident, brain disorders, computer tomography, CT angiography, non-contrast head computed tomography, intravenous thrombolysis, National Institutes of Health Stroke Scale