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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013796
Receipt No. R000016082
Scientific Title Clinical survey of acute ischemic stroke patients with hyperintense vessels on FLAIR images.
Date of disclosure of the study information 2014/04/23
Last modified on 2016/10/28

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Basic information
Public title Clinical survey of acute ischemic stroke patients with hyperintense vessels on FLAIR images.
Acronym Clinical survey of acute ischemic stroke patients with hyperintense vessels on FLAIR images.
Scientific Title Clinical survey of acute ischemic stroke patients with hyperintense vessels on FLAIR images.
Scientific Title:Acronym Clinical survey of acute ischemic stroke patients with hyperintense vessels on FLAIR images.
Region
Japan

Condition
Condition Cerebrovascular diseases
Classification by specialty
Medicine in general Neurology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigated the time course of hyperintense vessels using FLAIR imaging in patients who received tissue plasminogen activator (t-PA) therapy, and assessed clinical course and outcome.
Basic objectives2 Others
Basic objectives -Others To clarify the relationship between hyperintense vessels and infarct volumes.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Favorable outcome (modified Rankin Scale0-1)
Key secondary outcomes Relationship between hyperintense vessels and infarct volumes.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Consecutive acute ischemic stroke patients with FLAIR hyperintense vessels who were admitted to our hospital and were treated with intravenous t-PA between October 2005 and December 2013
Key exclusion criteria (1) patients with acute ischemic stroke in the territory of posterior circulation or isolated anterior cerebral artery, (2) patients who were treated with endovascular treatment, (3) patients without hyperintense vessels, and (4) patients with premorbid modified Rankin Scale (mRS) score >1
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Sakuta
Organization Kawasaki Medical School
Division name Department of Stroke Medicine
Zip code
Address 577 Matsushima, Kurashiki, Okayama, Japan
TEL 086-462-1111
Email kenichisakuta@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Sakuta
Organization Kawasaki Medical School
Division name Department of Stroke Medicine
Zip code
Address 577 Matsushima, Kurashiki, Okayama, Japan
TEL 086-462-1111
Homepage URL
Email kenichisakuta@yahoo.co.jp

Sponsor
Institute Department of Stroke Medicine, Kawasaki Medical School
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 川崎医科大学 (岡山県)

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 30 Day
Last follow-up date
2014 Year 05 Month 01 Day
Date of closure to data entry
2014 Year 05 Month 02 Day
Date trial data considered complete
2014 Year 05 Month 03 Day
Date analysis concluded
2015 Year 04 Month 30 Day

Other
Other related information Background: Hyperintense vessels (HV) detected in patients with acute ischemic stroke are considered as indicator of hypoperfusion. Therefore, the decrement of HV would be an indicator of reperfusion. We investigated the time course of HV using FLAIR imaging in patients who received tissue plasminogen activator (t-PA) therapy, and assessed clinical course and outcome.
Methods: Consecutive patients with acute ischemic stroke in middle cerebral artery (MCA) area who were treated with intravenous t-PA were included in this study. Patients were studied by MRI twice, on admission and 1 hour after t-PA infusion. Detected HV were assigned to the matching boundaries of the ASPECTS territories. Patients were divided into two groups according to the presence or absence of decrement of HV (DHV). Favorable outcome was defined as modified Rankin Scale score of 0 to 1.
Results:We analyzed 118 patients (73 men, 45 women; mean age, 76years, baseline NIHSS 13), and 52 patients had DHV. The median number of HV scores on admission was 5, and those of 1 hour after t-PA infusion was 4. Patients with DHV shows lower NIHSS time course (P<0.001), smaller infarct volumes time course (P<0.001), and increment of frequency of favorable outcome (56% versus 20%, P<0.001) compared with those without DHV. In a multivariable logistic regression model, DHV were independently associated with favorable outcome (OR 3.59, 95% CI 1.58-9.97, P<0.01) after adjusting age, sex, glucose, atrial fibrillation, ICA occlusion, baseline NIHSS, time from stroke onset to treatment, infarct volume on admission.
Conclusion: DHV in acute ischemic stroke patients in MCA area who were treated with t-PA was associated with milder clinical severity, smaller infarct volumes, and strongly predicts favorable outcome.

Management information
Registered date
2014 Year 04 Month 23 Day
Last modified on
2016 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016082

Research Plan
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Research case data specifications
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Research case data
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