Multimodal CT Examination in Stroke Mimics Diagnosis

ConditionStroke Mimics

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity Hospital Ostrava

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial population

All consecutive adult patients \>18 years of age with 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 will be enrolled to the study.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Multimodal brain CT
Diagnostic test
Multimodal brain CT includes NCCT, CTP, and CTA
Magnetic resonance imaging (MRI)
Diagnostic test
MRI examination will be performed between the 3rd and 7th day after the admission to the hospital

Treatment groups

3,000 Participants

are divided into 1 treatment group

Group A: Patients with neurological deficits (stroke or SM)2 interventions

Trial outcomes

Primary outcomes

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 (%)

Time frame

up to 7 days

Secondary outcomes

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).

Time frame

3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Ostrava

Lead sponsor

University of Ostrava

Collaborator

České Budějovice Hospital