NCT03161691

Brief Summary

Single-center, single-arm pilot study to evaluate the ability of C-arm computed tomography imaging to assess perfusion parameters, collateral vessels, recanalization and brain ischemia in patients with suspected or proven ischemic stroke or brain ischemia in the neuro-angiography suite.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

1.9 years

First QC Date

May 18, 2017

Last Update Submit

October 15, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with clinically valuable CACT perfusion images based on a 5-point Likert scale

    C-arm computed tomography acquisition perfusion/collateral protocols that provide sufficient image quality to be able to assess ischemic brain perfusion, recanalization and ischemic regions effectively. A 5-point Likert scale questionnaire will be used to evaluate image quality. Cerebral blood volume measurements will also be calculated by image processing software.

    1 year

Secondary Outcomes (1)

  • Number of participants with CACT perfusion images of comparable quality to standard imaging modalities based on a 5-point Likert scale

    1 year

Study Arms (1)

Ischemic Stroke

Percutaneous neurovascular treatment of acute ischemic stroke patients.

Procedure: Percutaneous treatment of ischemic stroke

Interventions

An additional C-arm CT imaging scan will be done during neurovascular treatment to evaluate perfusion and collateral vessels in ischemic stroke patients.

Ischemic Stroke

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected or proven ischemic stroke or brain ischemia who require diagnostic and/or interventional imaging in the neuro-angiography suite.

You may qualify if:

  • Subject has suspected or proven ischemic stroke or brain ischemia.
  • Subject requires diagnostic and/or interventional imaging in the neuro-angiography suite.
  • Subject or subject's legally authorized representative has signed an institutionally approved research informed consent form.
  • Subject ≥ 18 years old.

You may not qualify if:

  • Subject or subject's legally authorized representative is unable or unwilling to consent to the study.
  • Subject with documented contrast medium injection contraindication due to severe kidney disease or allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital - University Health Network

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Vitor Pereira, MD

    University Health Network - Toronto Western Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vitor Pereira, MD

CONTACT

Alex Kostynskyy, MBBS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Radiology and Surgery

Study Record Dates

First Submitted

May 18, 2017

First Posted

May 22, 2017

Study Start

May 11, 2017

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

October 16, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations