UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024174 |
|---|---|
| Receipt number | R000027830 |
| Scientific Title | The context of the autonomic nervous and pathology in acute stroke |
| Date of disclosure of the study information | 2016/09/26 |
| Last modified on | 2022/04/02 16:48:16 |
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Basic information
Public title
The context of the autonomic nervous and pathology in acute stroke
Acronym
The context of the autonomic nervous system and stroke
Scientific Title
The context of the autonomic nervous and pathology in acute stroke
Scientific Title:Acronym
The context of the autonomic nervous system and stroke
Region
| Japan |
Condition
Condition
cerebral infarction, cerebral hemorrhage
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The reaction to light of acute stroke patients to evaluate the autonomic neuropathy by quantitative analysis, and analysis of the relevance of a medical condition, such as the severity and prognosis, consider the usefulness of the autonomic nerve function assessment in acute stroke to.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Background information: gender, age, disease type, the difference between right and left of the lesion
Physical findings: blood pressure, pulse rate, at the time of admission and at discharge NIHSS , at the time of admission and at discharge mRS
Laboratory findings: blood tests, ECG, image inspection, the light facing the program each parameter
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The period of intervention to the subject: up to the time of discharge from the time of admission
Test time: about 5 seconds, including a red light for one second lights, about 5 seconds, including a blue light for one second lighting
Number of times: 2 times
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
Acute stroke patients within-onset 1 week
Key exclusion criteria
If you agree to the research can not be obtained
Within the orbit, or if the laceration or edema are found in soft tissue
Patients with, glaucoma, age-related macular degeneration, the merger of retinal diseases such as retinitis pigmentosa
Patients after surgery, affecting the pupil
If the pupil to the taking-instilled affect drug (mydriatic: Mydrin P, Mydrin M, atropine, Pibarefurin, Neoshinejin, miotics: pilocarpine)
Patients & physician determines that not appropriate
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Doyu |
Organization
Aichi Medical University
Division name
Department of Neurology
Zip code
4801195
Address
Aichi Prefecture, Nagakute Yazakokarimata 1-1
TEL
0561-62-3311(ext.23510)
mdoyu@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Nakashima |
Organization
Aichi Medical University
Division name
Department of Neurology, Stroke Center
Zip code
4801195
Address
Aichi Prefecture, Nagakute Yazakokarimata 1-1
TEL
0561-62-3311(ext.23510)
Homepage URL
nakashima.kouji.295@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University Hospital Ethical Review Board
Address
Aichi Prefecture, Nagakute Yazakokarimata 1-1
Tel
0561-62-3311(ext.34744)
kanrika@aichi-med-u.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
| 2016 | Year | 09 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 26 | Day |
Last modified on
| 2022 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027830
