Stroke, AcuteCTPNCT04105257
Evaluation of Diagnostic Performance of Cerebral Perfusion Scans in Pseudo-Stroke
A study testing All patients in people with Stroke, Acute, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
When a patient is received with the context of acute stroke, they undergo a fast neurological evaluation and obtain a basic appraisal composed of a non-contrast endovascular cerebral scan and an angiography scan of intracranial blood vessels and the neck. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- All patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 20 Oct 2019to 4 Oct 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission at CHUM for acute neurological deficit <4,5h (since the onset of symptoms)
- Potential candidate for an intravenous thrombolysis
- Cerebral angioscan performed at CHUM at the time of admission
- Age ≥ 18 years
- Observed period from September 2019 à June 2020
Who cannot join
- Contraindication to intravenous thrombolysis according to the doctor in charge of treatment;
- Indication of a thrombectomy;
- Incomplete exam or exam of insufficient technical quality for a reliable radiological interpretation;
- Contraindication against MRI .
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, QC - Québec, H2X0C1
About this study
Official title: Evaluation of Diagnostic Performance of Cerebral Perfusion Scans in Pseudo-Stroke: Exploratory Study of Diagnostic Performance
When a patient is received with the context of acute stroke, they undergo a fast neurological evaluation and obtain a basic appraisal composed of a non-contrast endovascular cerebral scan and an angiography scan of intracranial blood vessels and the neck. Once the structural lesion (hemorrhage, tumor, etc.) is absent, signs of early infracts and confirmed acute intracranial arterial occlusion, the possibility of a pseudo-stroke dwells in the differential diagnostic.
Certain characteristics of history and clinical evaluation create sufficient doubt to evoke the possibility of a pseudo-stroke. In fact, this population is mostly female and the cardiovascular risk factors are less prevalent in this group than for the group of stroke victims. It is on average the youngest and presents a less severe deficit. For the rest, medical antecedents often help to evoke a diagnosis of pseudo-stroke.
Read the detailed description
With this study, the investigators wish to evaluate the diagnostic value of two additional radiological examinations:
- Computed tomography perfusion (CTP) imaging to evaluate blood flow in the brain;
- Imaging by magnetic resonance (MRI) of the brain to detect lesions from a cerebral vascular accident (stroke) not visible on standard imaging of the brain.
The proposed additional examinations (CTP and MRI) are tests that are currently used at the CHUM. Those are not experimental tests. These tests are commonly used when doctors wants a further investigation to clarify the cause of the neurological symptoms. These tests are usually done in a semi-urgent or non-urgent situations. In the present study they will be done urgently. The investigators wish to determine if obtaining these additional tests in emergency will change the decision of whether to administer the drug (thrombolysis). The investigators want to determine whether one imaging test is sufficient or if both exams are needed to help clinical decision-making. Please note that urgent access to perfusion CT and brain MRI is not considered routine care, since the value of these additional tests has yet to be demonstrated.
- Conditions
- Stroke, Acute
- Being tested
- All patients
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All patientsDiagnostic test
Comparison of the results of the CTP with MRI
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | All patients seen at emergency with acute neurological deficit will be assessed if eligible to CTP/MRI Receives: Diagnostic Test: All patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensibility
proportion of patients that are correctly identified as having a pseudo-stroke
Measured: : Immediately after the procedure (CTP scan/MRI)
Specificity
proportion of patient that are correctly identified as not having a pseudo-stroke
Measured: Immediately after the procedure (CTP scan/MRI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start20 Oct 2019
- Primary completion4 Oct 2022
- Study completion4 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Guilbert, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)Laura Gioia, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105257
- Sponsor's protocol ID
- CE19.072
- Acronym
- CTP
- Status last verified
- Dec 2022
- First submitted
- 23 Sep 2019
- Last updated
- 12 Dec 2022
- 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 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Performance of Cerebral Perfusion Scans in Pseudo-Stroke: Exploratory Study of Diagnostic Performance
- ClinicalTrials.gov ID
- NCT04105257
- Acronym / sponsor ID
- CTP / CE19.072
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 26 Sep 2019 (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.
When a patient is received with the context of acute stroke, they undergo a fast neurological evaluation and obtain a basic appraisal composed of a non-contrast endovascular cerebral scan and an angiography scan of intracranial blood vessels and the neck. Once the structural lesion (hemorrhage, tumor, etc.) is absent, signs of early infracts and confirmed acute intracranial arterial occlusion, the possibility of a pseudo-stroke dwells in the differential diagnostic.
Certain characteristics of history and clinical evaluation create sufficient doubt to evoke the possibility of a pseudo-stroke. In fact, this population is mostly female and the cardiovascular risk factors are less prevalent in this group than for the group of stroke victims. It is on average the youngest and presents a less severe deficit. For the rest, medical antecedents often help to evoke a diagnosis of pseudo-stroke.
Detailed description
With this study, the investigators wish to evaluate the diagnostic value of two additional radiological examinations:
- Computed tomography perfusion (CTP) imaging to evaluate blood flow in the brain;
- Imaging by magnetic resonance (MRI) of the brain to detect lesions from a cerebral vascular accident (stroke) not visible on standard imaging of the brain.
The proposed additional examinations (CTP and MRI) are tests that are currently used at the CHUM. Those are not experimental tests. These tests are commonly used when doctors wants a further investigation to clarify the cause of the neurological symptoms. These tests are usually done in a semi-urgent or non-urgent situations. In the present study they will be done urgently. The investigators wish to determine if obtaining these additional tests in emergency will change the decision of whether to administer the drug (thrombolysis). The investigators want to determine whether one imaging test is sufficient or if both exams are needed to help clinical decision-making. Please note that urgent access to perfusion CT and brain MRI is not considered routine care, since the value of these additional tests has yet to be demonstrated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Diagnostic Test: All patientsAll patients seen at emergency with acute neurological deficit will be assessed if eligible to CTP/MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admission at CHUM for acute neurological deficit <4,5h (since the onset of symptoms)
- Potential candidate for an intravenous thrombolysis
- Cerebral angioscan performed at CHUM at the time of admission
- Age ≥ 18 years
- Observed period from September 2019 à June 2020
Key exclusion criteria (4 listed)
- Contraindication to intravenous thrombolysis according to the doctor in charge of treatment;
- Indication of a thrombectomy;
- Incomplete exam or exam of insufficient technical quality for a reliable radiological interpretation;
- Contraindication against MRI .
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 |
|---|---|---|
| All patientsComparison of the results of the CTP with MRI | Diagnostic test | All patients |
Primary outcome
Sensibility
Time frame: : Immediately after the procedure (CTP scan/MRI)
proportion of patients that are correctly identified as having a pseudo-stroke
Specificity
Time frame: Immediately after the procedure (CTP scan/MRI)
proportion of patient that are correctly identified as not having a pseudo-stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- 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.
Francois Guilbert, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Laura Gioia, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All patients in people with Stroke, Acute, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 12 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensibility (time frame: : Immediately after the procedure (CTP scan/MRI)). The study lists 2 primary outcomes in all. 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 12 Dec 2022.