Perfusion and Collaterals Imaging With C-arm CT

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03161691
• Other study ID #: TWH -Ver. 3.0 March 17 2017
• Status: Recruiting
• Start date: May 11, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: October 2018
• Source: University Health Network, Toronto
• Contact: Vitor Pereira, MD
• Phone: (416) 603 5800
• Email: vitor.pereira[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital - University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Philips Healthcare

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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