Clinical trial NCT03161691: Perfusion and Collaterals Imaging With C-arm CT
Official title: Perfusion and Collateral Imaging Using C-arm Computed Tomography in the Neuro-Angiography Suite
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2017-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with clinically valuable CACT perfusion images based on a 5-point Likert scale
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with CACT perfusion images of comparable quality to standard imaging modalities based on a 5-point Likert scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital - University Health Network
state: Ontario
Study officials:
affiliation: University Health Network - Toronto Western Hospital
name: Vitor Pereira, MD
role: PRINCIPAL_INVESTIGATOR
References: