Ischemic StrokeNCT03161691
Perfusion and Collaterals Imaging With C-arm CT
An observational study of Ischemic Stroke, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Percutaneous treatment of ischemic stroke
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 11 May 2017to 1 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with suspected or proven ischemic stroke or brain ischemia who require diagnostic and/or interventional imaging in the neuro-angiography suite.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital - University Health Network
Toronto, Ontario, M5T 2S8
Vitor Pereira, MD, (416) 603 5800 ext. 5564, vitor.pereira@uhn.ca
Alex Kostynskyy, MBBS, (416) 603 5800 ext. 4806, alex.kostynskyy@uhn.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Percutaneous treatment of ischemic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous treatment of ischemic strokeProcedure or surgery
An additional C-arm CT imaging scan will be done during neurovascular treatment to evaluate perfusion and collateral vessels in ischemic stroke patients.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Stroke | Percutaneous neurovascular treatment of acute ischemic stroke patients. Receives: Procedure: Percutaneous treatment of ischemic stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start11 May 2017
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Principal investigator, Vitor Pereira, University Health Network, Toronto
- Investigators
- Vitor Pereira, MD, Principal investigator, University Health Network - Toronto Western Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161691
- Sponsor's protocol ID
- TWH -Ver. 3.0 March 17 2017
- Status last verified
- Oct 2018
- First submitted
- 18 May 2017
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion and Collateral Imaging Using C-arm Computed Tomography in the Neuro-Angiography Suite
- ClinicalTrials.gov ID
- NCT03161691
- Acronym / sponsor ID
- TWH -Ver. 3.0 March 17 2017
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 11 May 2017 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ischemic Stroke | – | Procedure: Percutaneous treatment of ischemic strokePercutaneous neurovascular treatment of acute ischemic stroke patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected or proven ischemic stroke or brain ischemia who require diagnostic and/or interventional imaging in the neuro-angiography suite.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous treatment of ischemic strokeAn additional C-arm CT imaging scan will be done during neurovascular treatment to evaluate perfusion and collateral vessels in ischemic stroke patients. | Procedure or surgery | Ischemic Stroke |
Primary outcome
Number of participants with clinically valuable CACT perfusion images based on a 5-point Likert scale
Time frame: 1 year
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 secondary outcome
Number of participants with CACT perfusion images of comparable quality to standard imaging modalities based on a 5-point Likert scale
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vitor Pereira, MD principal investigator
University Health Network - Toronto Western Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vitor Pereira, MD ((416) 603 5800 ext. 5564, vitor.pereira@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with clinically valuable CACT perfusion images based on a 5-point Likert scale (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.