- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02988492
Acute Stroke Thrombectomy: Does CT Perfusion Accurately Predict Infarct on MRI After Recanalization
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 Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1Y 4E9
- The Ottawa Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: MRI perfusion imaging
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the sensitivity and specificity of CTP
Time Frame: Up to 24 months
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The primary outcome of our study is to evaluate the sensitivity and specificity of CTP in predicting infarct on 24 hour DWI---MRI.
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Up to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Correlate advanced imaging to clinical outcome
Time Frame: Up to 24 months
|
The secondary outcome of our study is to correlate advanced imaging to clinical outcome at 30 days.
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Up to 24 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Daniela Iancu, MD, The Ottawa Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MR-RETRIEVE Protocol
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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