MR-based Collateral Imaging to Predict Response to Endovascular Treatment of Stroke (FAST-COLL Study)

Study Overview
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Brief Summary
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Based on the results of recent randomized controlled trials, current international guidelines recommend the initiation of endovascular treatment within 6 hours of symptom onset for acute ischemic stroke. Endovascular treatment may be beneficial in selected patients beyond 6 hour time window. In particular, treatment response to endovascular therapy may be greatly influenced by pretreatment collateral status. The aim of this study is to evaluate whether MRI-based collateral imaging (the Fast Analysis SysTem for COLLaterals, 'FAST-COLL') is feasible and can predict the response to endovascular treatment in a wide range of patients with acute ischemic stroke .

Official Title
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MR-based Collateral Imaging to Predict Response to Endovascular Treatment of Stroke (FAST-COLL Study)

Conditions
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Stroke

Intervention / Treatment
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* Procedure: Endovascular treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute ischemic stroke Age 20 years and older Disabling stroke defined as a baseline NIHSS > 5 at the time of arrival Onset (last-seen-well) time to endovascular treatment time < 12 hours Confirmed symptomatic intracranial occlusion, based on CT or MR angiography, at one or more of the following locations: Carotid T/L, M1 MCA, or M1-MCA equivalent (2 or more M2-MCAs) Signed informed consent or appropriate signed deferral of consent where approved Exclusion Criteria: Baseline non-contrast CT reveals a moderate/large core defined as extensive early ischemic changes of ASPECTS 0-5 in the territory of symptomatic intracranial occlusion. Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic Unable to undergo MRI (contraindicated or poor cooperation) Patient has a severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient Pregnant females as determined by positive urine hCG test or lactating females

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endovascular treatment|Endovascular mechanical thrombectomy or endovascular delivery of thrombolytic agent|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-days functional outcome | 90-days modified Rankin Scale ≤ 2 | 90-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early neurologic improvement | An 8-point or more improvement on the NIH score when comparing the baseline score or a NIHSS score of 0-1, at 24 hours. | 24 hours | 
| Symptomatic hemorrhagic transformation | Occurrence of an increase in the National Institutes of Health Stroke Scale (NIHSS) score of 4 or more points in the setting of local or remote parenchymal hematoma. | During initial admission | 
| Successful recanalization | Defined as modified Thrombolysis in Cerebral Infarction (mTICI) ≥ 2b | within 24 hours of symptom onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Collateral status, Endovascular treatment