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Recruiting NCT06045455

Multimodal CT Examination in Stroke Mimics Diagnosis

— Observational Stroke Mimics

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multimodal brain CT, Magnetic resonance imaging (MRI).
Who it may be relevant to
Registry conditions: Stroke Mimics. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

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

Primary outcome measures

  • The difference of patients with SM [Time frame: up to 7 days]
Secondary outcome measures (1)
  • Pharmacoeconomic analysis [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Czechia · 3 centers
  • University of Ostrava — Ostrava
  • University Hospital Ostrava — Ostrava
  • Hospital České Budějovice — České Budějovice

Publications

  • Merino JG, Luby M, Benson RT, Davis LA, Hsia AW, Latour LL, Lynch JK, Warach S. Predictors of acute stroke mimics in 8187 patients referred to a stroke service. J Stroke Cerebrovasc Dis. 2013 Nov;22(8):e397-403. doi: 10.1016/j.jstrokecerebrovasdis.2013.04.018. Epub 2013 May 13. PMID 23680681
  • H Buck B, Akhtar N, Alrohimi A, Khan K, Shuaib A. Stroke mimics: incidence, aetiology, clinical features and treatment. Ann Med. 2021 Dec;53(1):420-436. doi: 10.1080/07853890.2021.1890205. PMID 33678099
  • Vilela P. Acute stroke differential diagnosis: Stroke mimics. Eur J Radiol. 2017 Nov;96:133-144. doi: 10.1016/j.ejrad.2017.05.008. Epub 2017 May 5. PMID 28551302
  • Siegler JE, Rosenberg J, Cristancho D, Olsen A, Pulst-Korenberg J, Raab L, Cucchiara B, Messe SR. Computed tomography perfusion in stroke mimics. Int J Stroke. 2020 Apr;15(3):299-307. doi: 10.1177/1747493019869702. Epub 2019 Aug 14. PMID 31409213
  • Smajlovic D, Sinanovic O. Sensitivity of the neuroimaging techniques in ischemic stroke. Med Arh. 2004;58(5):282-4. PMID 15628251
  • Austein F, Huhndorf M, Meyne J, Laufs H, Jansen O, Lindner T. Advanced CT for diagnosis of seizure-related stroke mimics. Eur Radiol. 2018 May;28(5):1791-1800. doi: 10.1007/s00330-017-5174-4. Epub 2017 Dec 7. PMID 29218615
  • Shelly S, Maggio N, Boxer M, Blatt I, Tanne D, Orion D. Computed Tomography Perfusion Maps Reveal Blood Flow Dynamics in Postictal Patients: A Novel Diagnostic Tool. Isr Med Assoc J. 2017 Sep;19(9):553-556. PMID 28971638
  • Ridolfi M, Granato A, Polverino P, Furlanis G, Ukmar M, Zorzenon I, Manganotti P. Migrainous aura as stroke-mimic: The role of perfusion-computed tomography. Clin Neurol Neurosurg. 2018 Mar;166:131-135. doi: 10.1016/j.clineuro.2018.01.032. Epub 2018 Jan 31. PMID 29414151

Identifiers

NCT: NCT06045455 · NU23-04-00336 · NU23-04-00336 · LM2023049

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗