NCT02668627

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

4 years

First QC Date

January 21, 2016

Last Update Submit

April 24, 2017

Conditions

Stroke

Keywords

StrokeCollateral statusEndovascular treatment

Outcome Measures

Primary Outcomes (1)

  • 90-days functional outcome

    90-days modified Rankin Scale ≤ 2

    90-days

Secondary Outcomes (3)

  • Early neurologic improvement

    24 hours

  • Symptomatic hemorrhagic transformation

    During initial admission

  • Successful recanalization

    within 24 hours of symptom onset

Interventions

Endovascular treatmentPROCEDURE

Endovascular mechanical thrombectomy or endovascular delivery of thrombolytic agent

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute ischemic stroke, eligible for endovascular treatment within 12 hours of symptom onset

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, 135710, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31554502DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Oh Young Bang, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong-Won Chung, MD

CONTACT

82234103599neurocjw@gmail.com

Yun Jeong Lim, RN

CONTACT

82221489697smcyunjeong@naver.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 21, 2016

First Posted

January 29, 2016

Study Start

December 1, 2013

Primary Completion

December 1, 2017

Study Completion

May 1, 2018

Last Updated

April 26, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Locations

KR(1)