UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038922 |
|---|---|
| Receipt number | R000044373 |
| Scientific Title | Clinical research aimed at shortening time to the start of endovascular therapy for large vessel occlusion acute ischemic stroke |
| Date of disclosure of the study information | 2019/12/18 |
| Last modified on | 2019/12/18 12:59:38 |
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Basic information
Public title
Clinical research aimed at shortening time to the start of endovascular therapy for large vessel occlusion acute ischemic stroke
Acronym
startEVT
Scientific Title
Clinical research aimed at shortening time to the start of endovascular therapy for large vessel occlusion acute ischemic stroke
Scientific Title:Acronym
startEVT
Region
| Japan |
Condition
Condition
acute ischemic stroke
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the time to the start of endovascular therapy for anterior circulation cerebral large vessel occlusion within 24 hours after onset. Identify factors that are effective in shortening time to treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time from arrival to start endovascular therapy
Key secondary outcomes
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
| 110 | years-old | > |
Gender
Male and Female
Key inclusion criteria
acute cerebral ischemic stroke(anterior circulation(ICA,M1,M2)
start endovascular therapy within 24hours after onset
Key exclusion criteria
Acute aortic dissection
Pregnant or possibility of pregnancy
Cases where imaging tests cannot be performed due to contrast media allergy or severe renal dysfunction
Cases transported after examination and treatment from another hospital
expression of withdrawal of consent
Cases where participation in this study is deemed inappropriate
Target sample size
850
Research contact person
Name of lead principal investigator
| 1st name | Kawakami |
| Middle name | |
| Last name | Osamu |
Organization
National hospital organization kyoto medical center
Division name
Department of Neurosurgery
Zip code
6128555
Address
Kyoto-city fushimi-ku fukakusa mukaihata-cho 1-1
TEL
0756419161
kawakami-nsu@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kawakami |
| Middle name | |
| Last name | Osamu |
Organization
National hospital organization kyoto medical center
Division name
Department of Neurosurgery
Zip code
6128555
Address
Kyoto-city fushimi-ku fukakusa mukaihata-cho 1-1
TEL
0756419161
Homepage URL
kawakami-nsu@umin.ac.jp
Sponsor or person
Institute
National hospital organization kyoto medical center
Institute
Department
Personal name
Funding Source
Organization
National hospital organization
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
National hospital organization
Address
Tokyo-to meguro-ku higashigaoka 2-5-21
Tel
03-5712-5050
700-kenkyu@mail.hosp.go.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 | 12 | Month | 18 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Time from arrival to start endovascular therapy
mRS(90 days after onset)
Management information
Registered date
| 2019 | Year | 12 | Month | 18 | Day |
Last modified on
| 2019 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044373
