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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003412
Receipt No. R000004133
Scientific Title Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Registry
Date of disclosure of the study information 2010/04/01
Last modified on 2010/03/31

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Basic information
Public title Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Registry
Acronym RESCUE-Japan Registry
Scientific Title Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Registry
Scientific Title:Acronym RESCUE-Japan Registry
Region
Japan

Condition
Condition acute cerebral ischemia
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify current treatment status and clinical results of acute cerebral ischemia in Japan, and also to obtain basic data to introduce and develop new treatments.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of mRS 0-2 at 90 days later
Key secondary outcomes (1) Recanalization of the target vessel (just after treatment and 24 hours later)
(2) Rate of mRS 0-1 at 90 days later
(3) NIHSS on admission and 7 days later
(4) Relationship between recanalization and prognosis
(5) symptomatic intracranial hemorrhage within 24 hours after onset
(6) Death within 90 days after onset
(7) Other adverse events

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) The patients admitted from July 1st 2010 to June 30th 2011.
2) The patients admitted within 24 hours after onset
3) The patients with major cerebral vessel occlusion
4) The patients whose agreement is obtained by the document.
Key exclusion criteria When the patient's participation is regarded as improper
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Yoshimura
Organization Gifu University
Division name Department of Neurosurgery
Zip code
Address 1-1 Yanagido, Gifu city, Gifu, Japan
TEL 058-230-6271
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yukiko Enomoto
Organization Graduate School of Medicine, Gifu University
Division name Department of Neurosurgery
Zip code
Address 1-1 Yanagido, Gifu city, Gifu, Japan
TEL 058-230-6271
Homepage URL http://www.rescue-japan.jp
Email nohgeka@gifu-u.ac.jp

Sponsor
Institute RESCUE-Japan Study Group
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2010 Year 04 Month 01 Day

Related information
URL releasing protocol http://www.rescue-japan.jp
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2010 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2011 Year 10 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 01 Month 01 Day
Date analysis concluded
2012 Year 03 Month 01 Day

Other
Other related information 1) NIH Stroke Scale
On admission, 1 hour after intravenous rt-PA injection, just after endovascular treatment, 24 hours after onset, 7 days later
2) modified Rankin Scale
before onset and 90 days later
3) Recanalization
Occlusion site before treatment and recanalized and occluded site after treatment

Management information
Registered date
2010 Year 03 Month 31 Day
Last modified on
2010 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004133

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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