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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02668627
• Other study ID #: SMC 2013-12-088
• Status: Recruiting
• Phase: N/A
• First received: January 21, 2016
• Last updated: April 24, 2017
• Start date: December 2013
• Est. completion date: May 2018

Study information

• Verified date: April 2017
• Source: Samsung Medical Center
• Contact: Jong-Won Chung, MD
• Phone: 82234103599
• Email: neurocjw[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• Endovascular treatment
Endovascular mechanical thrombectomy or endovascular delivery of thrombolytic agent

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center, Sungkyunkwan University School of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-days functional outcome	90-days modified Rankin Scale = 2	90-days
Secondary	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
Secondary	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
Secondary	Successful recanalization	Defined as modified Thrombolysis in Cerebral Infarction (mTICI) = 2b	within 24 hours of symptom onset