NCT06045455

Multimodal CT Examination in Stroke Mimics Diagnosis

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Stroke Mimics

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-09-21
• Last updated: 2024-01-16

Locations

3 sites across 1 country: Czechia