StrokeNCT02988492
Acute Stroke Thrombectomy: Does CT Perfusion Accurately Predict Infarct on MRI After Recanalization
A study testing MRI perfusion imaging in people with Stroke, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The newest generation of stent---retrievers results in higher recanalization rates and faster recanalization time compared to older generation endovascular therapies for acute stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- MRI perfusion imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2018to 1 Oct 2020
- 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 NECT, CTA neck and COW or multi-phase CTA or CTP. Follow---up 24 hr DWI---MRI performed
- Endovascular therapy performed for acute anterior circulation stroke as per clinical practice.
- Patient with an angiographically documented ICA, M1 or M2 occlusion
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The newest generation of stent---retrievers results in higher recanalization rates and faster recanalization time compared to older generation endovascular therapies for acute stroke. Advanced neuroimaging can potentially improve the assessment of infarct core and inform decision---making in patients being considered for endovascular therapy. Evaluation of infarct core may be performed with NECT, CTASI or CT perfusion. In the past, evaluation of CTP in predicting core infarct in acute stroke has been limited because recanalization status was lacking. In addition, final infarct size may be underestimated on NECT compared with MRI. These two limitations can now be addressed: the new generation of stent---retrievers allows accurate determination recanalization time; evaluating the test characteristics of CTP using 24 hour DWI---MRI as the reference standard can be readily performed.
We aim to prospectively investigate the sensitivity and specificity of whole---brain CTP in predicting 24 hour DWI---MRI infarct in patients with acute proximal anterior circulation occlusions successfully recanalized with endovascular treatment.
- Conditions
- Stroke
- Being tested
- MRI perfusion imaging
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI perfusion imagingDevice
Evaluate the sensitivity and specificity of whole---brain CTP in predicting 24 hour DWI---MRI infarct in patients with acute proximal anterior circulation occlusions successfully recanalized with endovascular treatment.
| Study group | Role | What they receive |
|---|---|---|
| MRI perfusion imaging | Other | MRI screening will be performed as per standard-of-care by the MRI technologist staff. Imaging will be performed with 1.5 T or 3 T systems (Magnetom Vision; Siemens, Erlangen, Germany) using a multisection, single shot, spin echo, echo planer imaging sequence. Diffusion gradients will be applied in each of the x, y and z directions with three b values (0, 500 and 1000 s/mm2). Imaging parameters include a TE of 94 ms, field of view of 23 cm, matrix of 128 and section thickness of 5.5 mm for the 1.5 T system and a TE of 83 ms, field of view of 23 cm, matrix of 128 and section thickness of 3 mm for the 3 T system. Conventional spin echo imaging also will be performed at each examination under T1 and T2 weighted conditions, with a fluid attenuated inversion recovery sequence and Time-of-flight MRA of the Circle-of-Willis. Receives: Device: MRI perfusion imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the sensitivity and specificity of CTP
The primary outcome of our study is to evaluate the sensitivity and specificity of CTP in predicting infarct on 24 hour DWI---MRI.
Measured: Up to 24 months
Secondary outcomes (1)
Correlate advanced imaging to clinical outcome
The secondary outcome of our study is to correlate advanced imaging to clinical outcome at 30 days.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start1 Mar 2018
- Primary completion1 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniela Iancu, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988492
- Sponsor's protocol ID
- MR-RETRIEVE Protocol
- Status last verified
- Oct 2021
- First submitted
- 6 Dec 2016
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Stroke Thrombectomy: Does CT Perfusion Accurately Predict Infarct on MRI After Recanalization
- ClinicalTrials.gov ID
- NCT02988492
- Acronym / sponsor ID
- MR-RETRIEVE Protocol
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 9 Dec 2016 (estimated)
- 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.
The newest generation of stent---retrievers results in higher recanalization rates and faster recanalization time compared to older generation endovascular therapies for acute stroke. Advanced neuroimaging can potentially improve the assessment of infarct core and inform decision---making in patients being considered for endovascular therapy. Evaluation of infarct core may be performed with NECT, CTASI or CT perfusion. In the past, evaluation of CTP in predicting core infarct in acute stroke has been limited because recanalization status was lacking. In addition, final infarct size may be underestimated on NECT compared with MRI. These two limitations can now be addressed: the new generation of stent---retrievers allows accurate determination recanalization time; evaluating the test characteristics of CTP using 24 hour DWI---MRI as the reference standard can be readily performed.
We aim to prospectively investigate the sensitivity and specificity of whole---brain CTP in predicting 24 hour DWI---MRI infarct in patients with acute proximal anterior circulation occlusions successfully recanalized with endovascular treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI perfusion imaging | Other | Device: MRI perfusion imagingMRI screening will be performed as per standard-of-care by the MRI technologist staff. Imaging will be performed with 1.5 T or 3 T systems (Magnetom Vision; Siemens, Erlangen, Germany) using a multisection, single shot, spin echo, echo planer imaging sequence. Diffusion gradients will be applied in each of the x, y and z directions with three b values (0, 500 and 1000 s/mm2). Imaging parameters include a TE of 94 ms, field of view of 23 cm, matrix of 128 and section thickness of 5.5 mm for the 1.5 T system and a TE of 83 ms, field of view of 23 cm, matrix of 128 and section thickness of 3 mm for the 3 T system. Conventional spin echo imaging also will be performed at each examination under T1 and T2 weighted conditions, with a fluid attenuated inversion recovery sequence and Time-of-flight MRA of the Circle-of-Willis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admission NECT, CTA neck and COW or multi-phase CTA or CTP. Follow---up 24 hr DWI---MRI performed
- Endovascular therapy performed for acute anterior circulation stroke as per clinical practice.
- Patient with an angiographically documented ICA, M1 or M2 occlusion
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| MRI perfusion imagingEvaluate the sensitivity and specificity of whole---brain CTP in predicting 24 hour DWI---MRI infarct in patients with acute proximal anterior circulation occlusions successfully recanalized with endovascular treatment. | Device | MRI perfusion imaging |
Primary outcome
Evaluate the sensitivity and specificity of CTP
Time frame: Up to 24 months
The primary outcome of our study is to evaluate the sensitivity and specificity of CTP in predicting infarct on 24 hour DWI---MRI.
1 secondary outcome
Correlate advanced imaging to clinical outcome
Time frame: Up to 24 months
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 8 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
Daniela Iancu, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI perfusion imaging in people with Stroke, run by Ottawa Hospital Research Institute 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 3 inclusion and 1 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 8 Oct 2021. 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?
Evaluate the sensitivity and specificity of CTP (time frame: Up to 24 months). 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 8 Oct 2021.