UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013796 |
|---|---|
| Receipt number | 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 05:01:10 |
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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
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
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
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
kenichisakuta@yahoo.co.jp
Sponsor or person
Institute
Department of Stroke Medicine, Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016082
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