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

• Conditions: Stroke

• Registration Number: NCT02668627
• Lead Sponsor: Samsung Medical Center

Brief Summary

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 .

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26
• Primary Completion: 2017-12
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
90-days functional outcome	90-days	90-days modified Rankin Scale ≤ 2

Secondary Outcome Measures

Name	Time	Method
Early neurologic improvement	24 hours	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.
Symptomatic hemorrhagic transformation	During initial admission	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.
Successful recanalization	within 24 hours of symptom onset	Defined as modified Thrombolysis in Cerebral Infarction (mTICI) ≥ 2b

Trial Locations

Locations (1)

Samsung Medical Center, Sungkyunkwan University School of Medicine; 🇰🇷 Seoul, Korea, Republic of