Perfusion and Collaterals Imaging With C-arm CT

Perfusion and Collateral Imaging Using C-arm Computed Tomography in the Neuro-Angiography Suite

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic Stroke
• Intervention / Treatment: Procedure: Percutaneous treatment of ischemic stroke

Detailed Description

In neurovascular disease, and stroke in particular, physicians often want to be able to detect regions of ischemia in the brain and the recanalization status of cerebral blood vessels. Perfusion and collateral vessel imaging is a possible approach for doing this. These imaging techniques are able to differentiate ischemic core in parenchymal tissue in the brain versus salvageable penumbra tissue around the core. Also the recanalization status of blood vessels can be evaluated using this technique. This study wishes to investigate if the x-ray C-arm in the treatment room can generate perfusion and collateral images of clinical value during treatment, using a technique known as C-arm computed tomography. If this study shows that to be the case, then it might be feasible in the future to bypass CT or MR perfusion/collateral imaging for some patients when they arrive at the hospital, since all this imaging can be done in the treatment room. In the future, this imaging approach may have the potential to simplify and improve patient workflows and reduce the time between hospital arrival and treatment for these patients and could also potentially compensate for missing imaging information.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • Toronto Western Hospital - University Health Network
      • Contact: Vitor Pereira, MD; Phone Number: 5564 (416) 603 5800; Email: vitor.pereira@uhn.ca
      • Contact: Alex Kostynskyy, MBBS; Phone Number: 4806 (416) 603 5800; Email: alex.kostynskyy@uhn.ca

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ischemic Stroke; Percutaneous neurovascular treatment of acute ischemic stroke patients.	Procedure: Percutaneous treatment of ischemic stroke; An additional C-arm CT imaging scan will be done during neurovascular treatment to evaluate perfusion and collateral vessels in ischemic stroke patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with CACT perfusion images of comparable quality to standard imaging modalities based on a 5-point Likert scale	CACT perfusion imaging and collateral vessel imaging protocols that are comparable in quality to other standard-of-care imaging modalities (such as CT) that are used for these purposes. A 5-point Likert scale questionnaire will be used to compare the imaging modalities. Cerebral blood volume measurements will also be evaluated based on image processing software calculations.	1 year

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Philips Healthcare
• Investigators: Principal Investigator: Vitor Pereira, MD, University Health Network - Toronto Western Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2017
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

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; Ischemic Stroke
• Other Study ID Numbers: TWH -Ver. 3.0 March 17 2017

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
• product manufactured in and exported from the U.S.: No