Evaluation of Diagnostic Performance of Cerebral Perfusion Scans in Pseudo-Stroke (CTP)

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Acute
• Intervention / Treatment: Diagnostic test: All patients

Detailed Description

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

1. Computed tomography perfusion (CTP) imaging to evaluate blood flow in the brain;
2. 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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • QC - Québec
    • Montréal, QC - Québec, Canada, H2X0C1
      • Centre Hospitalier de l'Université de Montréal (CHUM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All patients; All patients seen at emergency with acute neurological deficit will be assessed if eligible to CTP/MRI	Diagnostic test: All patients; Comparison of the results of the CTP with MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensibility	proportion of patients that are correctly identified as having a pseudo-stroke	: Immediately after the procedure (CTP scan/MRI)
Specificity	proportion of patient that are correctly identified as not having a pseudo-stroke	Immediately after the procedure (CTP scan/MRI)

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Francois Guilbert, MD, Centre Hospitalier de l'Université de Montréal (CHUM); Principal Investigator: Laura Gioia, MD, Centre Hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2019
• Primary Completion (Actual): October 4, 2022
• Study Completion (Actual): October 4, 2022

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: CE19.072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No