UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037253 |
|---|---|
| Receipt number | R000041087 |
| Scientific Title | Database research Utilizing National Claims Data in Japan:Retrospective Cohort Study of Mechanical Thrombectomy for Acute Ischemic Stroke |
| Date of disclosure of the study information | 2019/07/03 |
| Last modified on | 2021/07/08 20:32:15 |
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Basic information
Public title
Database research Utilizing National Claims Data in Japan:Retrospective Cohort Study of Mechanical Thrombectomy for Acute Ischemic Stroke
Acronym
Outcome of Mechanical Thrombectomy for Acute IschemicStroke by Japanese National Claims Database
Scientific Title
Database research Utilizing National Claims Data in Japan:Retrospective Cohort Study of Mechanical Thrombectomy for Acute Ischemic Stroke
Scientific Title:Acronym
Outcome of Mechanical Thrombectomy for Acute IschemicStroke by Japanese National Claims Database
Region
| Japan |
Condition
Condition
Acute ischemic stroke
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is two fold. The first is to evaluate the mid-term outcome of mechanical thrombectomy in Japanese real world. The second is to assess cost-effectiveness of the treatment in Japanese insurance system
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Hospitalized term (days) between index stroke and 2 years after it
2. Medical cost between index stroke and 2 years after it
Key secondary outcomes
1. All cause mortality
2. Recurrence of stroke
3. Duration of index hospitalization and destination after discharge
4. Rehabiliation
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
ICD-10, I630-639 or I650-653 or I660-I669
AND
Brain CT or MRI examination on the admission day or the day after that
AND
Japanese procedure code of rt-PA infusion
AND
use of alteplase
Key exclusion criteria
1) Patients who had other procedures which was not related with the index stroke
2) Patient who had the management of acute dissection or aortic aneurysm during study period
3) Patient who had AMI during the study period
4) Patients who had management of active malignancy during the study period
5) Patients who had radiation therapy for active malignant neoplasm during the study period
6) Patient who had mechanical circulatory support during the study period
7) Patients who had maintenance dialysis
8) Patients who had organ transplantation
9) Patient who had trauma
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Takura |
Organization
The University of Tokyo, Faculty of Medicine
Division name
Medical Economics
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, 113-8655, Tokyo, Japan
TEL
+817069363485
value-s@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Takura |
Organization
The University of Tokyo, Faculty of Medicine
Division name
Medical Economics
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, 113-8655, Tokyo, Japan
TEL
+817069363485
Homepage URL
value-s@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo, Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Pharmaceuticals and medical Devices Agency of Japan
Name of secondary funder(s)
Pharmaceuticals and medical Devices Agency of Japan
IRB Contact (For public release)
Organization
The University of Tokyo, Faculty of Medicine, Institutional Review Board
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
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
| 2019 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
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
| Delay expected |
Results Delay Reason
The analyses has not been finalized
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
Preinitiation
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 03 | Day |
Last modified on
| 2021 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041087
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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