Study Results
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Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2023-10-01
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients with neurological deficits (stroke or SM)
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.
Multimodal brain CT
Multimodal brain CT includes NCCT, CTP, and CTA
Magnetic resonance imaging (MRI)
MRI examination will be performed between the 3rd and 7th day after the admission to the hospital
Interventions
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Multimodal brain CT
Multimodal brain CT includes NCCT, CTP, and CTA
Magnetic resonance imaging (MRI)
MRI examination will be performed between the 3rd and 7th day after the admission to the hospital
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Ostrava
OTHER
České Budějovice Hospital
OTHER
University Hospital Ostrava
OTHER
Responsible Party
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Principal Investigators
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Michal Bar, prof.,MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
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Hospital České Budějovice
České Budějovice, Jihočeský kraj, Czechia
University of Ostrava
Ostrava, Moravian-Silesian Region, Czechia
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Smajlovic D, Sinanovic O. Sensitivity of the neuroimaging techniques in ischemic stroke. Med Arh. 2004;58(5):282-4.
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.
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.
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.
Campbell BC, Weir L, Desmond PM, Tu HT, Hand PJ, Yan B, Donnan GA, Parsons MW, Davis SM. CT perfusion improves diagnostic accuracy and confidence in acute ischaemic stroke. J Neurol Neurosurg Psychiatry. 2013 Jun;84(6):613-8. doi: 10.1136/jnnp-2012-303752. Epub 2013 Jan 25.
Logallo N, Novotny V, Assmus J, Kvistad CE, Alteheld L, Ronning OM, Thommessen B, Amthor KF, Ihle-Hansen H, Kurz M, Tobro H, Kaur K, Stankiewicz M, Carlsson M, Morsund A, Idicula T, Aamodt AH, Lund C, Naess H, Waje-Andreassen U, Thomassen L. Tenecteplase versus alteplase for management of acute ischaemic stroke (NOR-TEST): a phase 3, randomised, open-label, blinded endpoint trial. Lancet Neurol. 2017 Oct;16(10):781-788. doi: 10.1016/S1474-4422(17)30253-3. Epub 2017 Aug 2.
Van Cauwenberge MGA, Dekeyzer S, Nikoubashman O, Dafotakis M, Wiesmann M. Can perfusion CT unmask postictal stroke mimics? A case-control study of 133 patients. Neurology. 2018 Nov 13;91(20):e1918-e1927. doi: 10.1212/WNL.0000000000006501. Epub 2018 Oct 17.
Pohl M, Hesszenberger D, Kapus K, Meszaros J, Feher A, Varadi I, Pusch G, Fejes E, Tibold A, Feher G. Ischemic stroke mimics: A comprehensive review. J Clin Neurosci. 2021 Nov;93:174-182. doi: 10.1016/j.jocn.2021.09.025. Epub 2021 Sep 20.
Dvornikova K, Kunesova V, Ely M, Ostry S, Cabal M, Reiser M, Machova L, Pavlinova M, Konde A, Elias P, Jonszta T, Havelka J, Volny O, Bar M. The importance of multimodal CT examination in stroke mimics diagnosis: design of prospective observational multicentre study. Front Neurol. 2024 Jun 4;15:1365986. doi: 10.3389/fneur.2024.1365986. eCollection 2024.
Other Identifiers
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NU23-04-00336
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
LM2023049
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NU23-04-00336
Identifier Type: -
Identifier Source: org_study_id
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