NCT04105257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

October 20, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2022

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

3 years

First QC Date

September 23, 2019

Last Update Submit

December 8, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

Study Arms (1)

All patients

OTHER

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

Diagnostic Test: All patients

Interventions

All patientsDIAGNOSTIC_TEST

Comparison of the results of the CTP with MRI

All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, QC - Québec, H2X0C1, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Francois Guilbert, MD

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR
  • Laura Gioia, MD

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 26, 2019

Study Start

October 20, 2019

Primary Completion

October 4, 2022

Study Completion

October 4, 2022

Last Updated

December 12, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations