UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical survey of acute ischemic stroke patients with hyperintense vessels on FLAIR images.
Title of the study (Brief title)	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	Kenichi Sakuta
Organization	Kawasaki Medical School
Division name	Department of Stroke Medicine
Address	577 Matsushima, Kurashiki, Okayama, Japan
TEL	086-462-1111
Email	kenichisakuta@yahoo.co.jp

Public contact
Name of contact person	Kenichi Sakuta
Organization	Kawasaki Medical School
Division name	Department of Stroke Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016082