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OpenTrials
Completed

NCT Number: NCT04105257

Evaluation of Diagnostic Performance of Cerebral Perfusion Scans in Pseudo-Stroke

When a patient is received with the context of acute stroke, they undergo a fast neurological evaluation and obtain a basic appraisal composed of a non-contrast endovascular cerebral scan and an angiography scan of intracranial blood vessels and the neck. Once the structural lesion (hemorrhage, tumor, etc.) is absent, signs of early infracts and confirmed acute intracranial arterial occlusion, the possibility of a pseudo-stroke dwells in the differential diagnostic.

Certain characteristics of history and clinical evaluation create sufficient doubt to evoke the possibility of a pseudo-stroke. In fact, this population is mostly female and the cardiovascular risk factors are less prevalent in this group than for the group of stroke victims. It is on average the youngest and presents a less severe deficit. For the rest, medical antecedents often help to evoke a diagnosis of pseudo-stroke.

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, QC - Québec, H2X0C1, Canada

About this study

With this study, the investigators wish to evaluate the diagnostic value of two additional radiological examinations:

  • Computed tomography perfusion (CTP) imaging to evaluate blood flow in the brain;
  • Imaging by magnetic resonance (MRI) of the brain to detect lesions from a cerebral vascular accident (stroke) not visible on standard imaging of the brain.

The proposed additional examinations (CTP and MRI) are tests that are currently used at the CHUM. Those are not experimental tests. These tests are commonly used when doctors wants a further investigation to clarify the cause of the neurological symptoms. These tests are usually done in a semi-urgent or non-urgent situations. In the present study they will be done urgently. The investigators wish to determine if obtaining these additional tests in emergency will change the decision of whether to administer the drug (thrombolysis). The investigators want to determine whether one imaging test is sufficient or if both exams are needed to help clinical decision-making. Please note that urgent access to perfusion CT and brain MRI is not considered routine care, since the value of these additional tests has yet to be demonstrated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Admission at CHUM for acute neurological deficit <4,5h (since the onset of symptoms)
  • Potential candidate for an intravenous thrombolysis
  • Cerebral angioscan performed at CHUM at the time of admission
  • Age ≥ 18 years
  • Observed period from September 2019 à June 2020

Exclusion criteria

  • Contraindication to intravenous thrombolysis according to the doctor in charge of treatment;
  • Indication of a thrombectomy;
  • Incomplete exam or exam of insufficient technical quality for a reliable radiological interpretation;
  • Contraindication against MRI .

Treatment and study plan

All patients

Diagnostic Test

Comparison of the results of the CTP with MRI

Primary outcomes

  1. Sensibility

    Time frame: : Immediately after the procedure (CTP scan/MRI)

    proportion of patients that are correctly identified as having a pseudo-stroke

  2. Specificity

    Time frame: Immediately after the procedure (CTP scan/MRI)

    proportion of patient that are correctly identified as not having a pseudo-stroke

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

Evaluation of Diagnostic Performance of Cerebral Perfusion Scans in Pseudo-Stroke: Exploratory Study of Diagnostic Performance

Acronym: CTP

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 26, 2019
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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