Multimodal CT Examination in Stroke Mimics Diagnosis

January 12, 2024 updated by: University Hospital Ostrava

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • Recruiting
        • University Hospital Ostrava
        • Contact:
        • Principal Investigator:
          • Michal Bar, prof.,MD,PhD
        • Sub-Investigator:
          • Ondřej Volný, Assoc.Prof.,MD,PhD
        • Sub-Investigator:
          • Kateřina Dvorníková, MD
        • Sub-Investigator:
          • Marcela Ely, Mgr.,PhD
        • Sub-Investigator:
          • Martin Čábal, MD
        • Sub-Investigator:
          • Linda Machová, MD,PhD
        • Sub-Investigator:
          • Adéla Kondé, Mgr.
      • Ostrava, Moravian-Silesian Region, Czechia, 70300
        • Recruiting
        • University of Ostrava
        • Contact:
        • Principal Investigator:
          • Pavel Eliáš, prof.,MD,CSc
        • Sub-Investigator:
          • Pavel Koscielnik, MD
        • Sub-Investigator:
          • Jaroslav Havelka, MD
        • Sub-Investigator:
          • Petr Novobilský, Ing.
        • Sub-Investigator:
          • Veronika Kunešová, PharmDr., PhD
    • South-Bohemian Region
      • České Budějovice, South-Bohemian Region, Czechia, 37001
        • Recruiting
        • Hospital Ceské Budejovice
        • Contact:
          • Svatopluk Ostrý, MD,PhD
          • Phone Number: 5801 0042038787
          • Email: ostry@nemcb.cz
        • Principal Investigator:
          • Svatopluk Ostrý, MD,PhD
        • Sub-Investigator:
          • Martin Reiser, MD
        • Sub-Investigator:
          • Markéta Pavlínová, MD
        • Sub-Investigator:
          • Lenka Bártová, Bc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference of patients with SM
Time Frame: up to 7 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacoeconomic analysis
Time Frame: 3 years

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).
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Collaborators

University of Ostrava
České Budějovice Hospital

Investigators

  • Principal Investigator: Michal Bar, prof.,MD,PhD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU23-04-00336 (Other Grant/Funding Number: Ministry of Health of the Czech Republic)
  • LM2023049 (Other Grant/Funding Number: STROCZECH, CZECRIN Large Research Infrastructure)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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