Acute Stroke Thrombectomy: Does CT Perfusion Accurately Predict Infarct on MRI After Recanalization
1 other identifier
interventional
40
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Mar 2018
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2016
CompletedFirst Posted
Study publicly available on registry
December 9, 2016
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedOctober 8, 2021
October 1, 2021
2.5 years
December 6, 2016
October 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 24 months
Secondary Outcomes (1)
Correlate advanced imaging to clinical outcome
Up to 24 months
Study Arms (1)
MRI perfusion imaging
OTHERMRI 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela Iancu, MD
The Ottawa Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2016
First Posted
December 9, 2016
Study Start
March 1, 2018
Primary Completion
September 1, 2020
Study Completion
October 1, 2020
Last Updated
October 8, 2021
Record last verified: 2021-10