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

NCT ID: NCT02668627

Last Updated: 2017-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2018-05-31

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 .

Detailed Description

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Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Endovascular treatment

Endovascular mechanical thrombectomy or endovascular delivery of thrombolytic agent

Intervention Type PROCEDURE

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Oh Young Bang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oh Young Bang, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jong-Won Chung, MD

Role: CONTACT

82234103599

Yun Jeong Lim, RN

Role: CONTACT

82221489697

Facility Contacts

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Jong-Won Chung, MD

Role: primary

82234101895

References

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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.

Reference Type DERIVED
PMID: 31554502 (View on PubMed)

Other Identifiers

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SMC 2013-12-088

Identifier Type: -

Identifier Source: org_study_id

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