Clinical trial NCT02668627: MR-based Collateral Imaging to Predict Response to Endovascular Treatment of Stroke (FAST-COLL Study)
Official title: MR-based Collateral Imaging to Predict Response to Endovascular Treatment of Stroke (FAST-COLL Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Stroke
Collateral status
Endovascular treatment
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute ischemic stroke, eligible for endovascular treatment within 12 hours of symptom onset

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 .


Eligibility criteria: 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

Primary outcomes:
measure: 90-days functional outcome
timeFrame: 90-days
Secondary outcomes:
measure: Early neurologic improvement
timeFrame: 24 hours
measure: Symptomatic hemorrhagic transformation
timeFrame: During initial admission
measure: Successful recanalization
timeFrame: within 24 hours of symptom onset
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University School of Medicine
Study officials:
affiliation: Samsung Medical Center
name: Oh Young Bang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu I, Bang OY, Chung JW, Kim YC, Choi EH, Seo WK, Kim GM, Menon BK, Demchuk AM, Goyal M, Hill MD. Admission Diffusion-Weighted Imaging Lesion Volume in Patients With Large Vessel Occlusion Stroke and Alberta Stroke Program Early CT Score of >/=6 Points: Serial Computed Tomography-Magnetic Resonance Imaging Collateral Measurements. Stroke. 2019 Nov;50(11):3115-3120. doi: 10.1161/STROKEAHA.119.026229. Epub 2019 Sep 26.