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

Primary Purpose

Stroke, Acute

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
All patients
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

  • Centre hospitalier de l'Université de Montréal (CHUM)

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All patients

Arm Description

All patients seen at emergency with acute neurological deficit will be assessed if eligible to CTP/MRI

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 23, 2019
Last Updated
December 8, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT04105257
Brief Title
Evaluation of Diagnostic Performance of Cerebral Perfusion Scans in Pseudo-Stroke
Acronym
CTP
Official Title
Evaluation of Diagnostic Performance of Cerebral Perfusion Scans in Pseudo-Stroke: Exploratory Study of Diagnostic Performance
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 20, 2019 (Actual)
Primary Completion Date
October 4, 2022 (Actual)
Study Completion Date
October 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All patients
Arm Type
Other
Arm Description
All patients seen at emergency with acute neurological deficit will be assessed if eligible to CTP/MRI
Intervention Type
Diagnostic Test
Intervention Name(s)
All patients
Intervention Description
Comparison of the results of the CTP with MRI
Primary Outcome Measure Information:
Title
Sensibility
Description
proportion of patients that are correctly identified as having a pseudo-stroke
Time Frame
: Immediately after the procedure (CTP scan/MRI)
Title
Specificity
Description
proportion of patient that are correctly identified as not having a pseudo-stroke
Time Frame
Immediately after the procedure (CTP scan/MRI)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Guilbert, MD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Gioia, MD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier de l'Université de Montréal (CHUM)
City
Montréal
State/Province
QC - Québec
ZIP/Postal Code
H2X0C1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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