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

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ClinicalTrials.gov Identifier: NCT02668627
Recruitment Status : Unknown
Verified April 2017 by Oh Young Bang, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : January 29, 2016
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Oh Young Bang, 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 .

Condition or disease Intervention/treatment
Stroke Procedure: Endovascular treatment

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MR-based Collateral Imaging to Predict Response to Endovascular Treatment of Stroke (FAST-COLL Study)
Study Start Date : December 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : May 2018

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


Primary Outcome Measures :
  1. 90-days functional outcome [ Time Frame: 90-days ]
    90-days modified Rankin Scale ≤ 2


Secondary Outcome Measures :
  1. Early neurologic improvement [ Time Frame: 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.

  2. Symptomatic hemorrhagic transformation [ Time Frame: 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.

  3. Successful recanalization [ Time Frame: within 24 hours of symptom onset ]
    Defined as modified Thrombolysis in Cerebral Infarction (mTICI) ≥ 2b



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute ischemic stroke, eligible for endovascular treatment within 12 hours of symptom onset
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668627


Contacts
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Contact: Jong-Won Chung, MD 82234103599 neurocjw@gmail.com
Contact: Yun Jeong Lim, RN 82221489697 smcyunjeong@naver.com

Locations
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Korea, Republic of
Samsung Medical Center, Sungkyunkwan University School of Medicine Recruiting
Seoul, Korea, Republic of, 135710
Contact: Jong-Won Chung, MD    82234101895    neurocjw@gmail.com   
Principal Investigator: Oh Young Bang, MD         
Sub-Investigator: Kwang Ho Lee, MD         
Sub-Investigator: Chin-Sang Chung, MD         
Sub-Investigator: Gyeong-Moon Kim, MD         
Sub-Investigator: Jong-Won Chung, MD         
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Oh Young Bang, MD Samsung Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oh Young Bang, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02668627    
Other Study ID Numbers: SMC 2013-12-088
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Oh Young Bang, Samsung Medical Center:
Stroke
Collateral status
Endovascular treatment
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases