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)

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 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)

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name