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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024174
Receipt No. 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 2019/04/02

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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)
Email 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
Email nakashima.kouji.295@mail.aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

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)
Email 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 Enrolling by invitation
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
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027830

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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