Multimodal CT Examination in Stroke Mimics Diagnosis

NCT06045455 | Recruiting

• 2 other identifiers: NU23-04-00336LM2023049
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Stroke Mimics

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pharmacoeconomic analysis

  3 years

Study Arms (1)

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.

Diagnostic Test: Multimodal brain CT; Diagnostic Test: Magnetic resonance imaging (MRI)

Interventions

Multimodal brain CT DIAGNOSTIC_TEST

Multimodal brain CT includes NCCT, CTP, and CTA

Patients with neurological deficits (stroke or SM)

Magnetic resonance imaging (MRI) DIAGNOSTIC_TEST

MRI examination will be performed between the 3rd and 7th day after the admission to the hospital

Patients with neurological deficits (stroke or SM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead
• University of Ostrava: collaborator
• České Budějovice Hospital: collaborator

Study Sites (3)

Hospital České Budějovice

České Budějovice, Jihočeský kraj, 37001, Czechia

RECRUITING

University of Ostrava

Ostrava, Moravian-Silesian Region, 70300, Czechia

RECRUITING

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

Related Publications (13)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Smajlovic D, Sinanovic O. Sensitivity of the neuroimaging techniques in ischemic stroke. Med Arh. 2004;58(5):282-4.

  PMID: 15628251 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 23355804 BACKGROUND

• 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.

  PMID: 28780236 BACKGROUND

• 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.

  PMID: 30333164 BACKGROUND

• 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.

  PMID: 34656244 BACKGROUND

• 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.

  PMID: 38895699 DERIVED

MeSH Terms

Conditions

Nervous System Diseases; Stroke; Brain Diseases

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Michal Bar, prof.,MD,PhD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3)