UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003412 |
|---|---|
| Receipt number | 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 01:39:19 |
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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
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
nohgeka@gifu-u.ac.jp
Sponsor or person
Institute
RESCUE-Japan Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004133
