UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022904 |
|---|---|
| Receipt number | R000026395 |
| Scientific Title | changes in the cerebral blood volume due to the posture change in acute ischemic stroke patients using a near-infrared time-resolved spectroscopy |
| Date of disclosure of the study information | 2016/06/27 |
| Last modified on | 2020/12/30 09:09:27 |
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Basic information
Public title
changes in the cerebral blood volume due to the posture change in acute ischemic stroke patients using a near-infrared time-resolved spectroscopy
Acronym
changes in the cerebral blood volume due to the posture change in acute ischemic stroke patients using a near-infrared time-resolved spectroscopy
Scientific Title
changes in the cerebral blood volume due to the posture change in acute ischemic stroke patients using a near-infrared time-resolved spectroscopy
Scientific Title:Acronym
changes in the cerebral blood volume due to the posture change in acute ischemic stroke patients using a near-infrared time-resolved spectroscopy
Region
| Japan |
Condition
Condition
Patients with first-ever stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare of the changes in fore head delta total hemoglobin in response to passive sitting (30 degree) measured within 72 hr and 7-10 days after onset
Basic objectives2
Others
Basic objectives -Others
diagnosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the changes in forehead delta total hemoglobin in response to passive sitting (30 degree) measured within 72 hr and 7-10 days after onset
Key secondary outcomes
1) Comparison of the changes in forehead delta oxy-hemoglobin in response to passive sitting (30 degree) measured within 72 hr and 7-10days after onset
2) Comparison of the changes in forehead delta deoxy-hemoglobin in response to passive sitting (30 degree) measured within 72 hr and 7-10days after onset
3) Comparison of the changes in forehead delta total-hemoglobin index (TOI) in response to passive sitting (30 degree) measured within 72 hr and 7-10 days after onset
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Forehead blood volume measurement obtained TRS-NIRS
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
1. First-ever stroke patient admitted to the hospital within 24 hours from onset
2. patients aged 20 y.o or more
3. Patients who gave written informed consent.
Key exclusion criteria
1. A history of stroke, brain contusion, and brain tumor
2. Unable to hold the 30-degree passive sitting position
3. Receive antihypertensive agents after hospitalization
4. Orthostatic hypotension
5. Skin disease (not suitable for application of the probe to forehead)
6. Patients cannot follow verbal instructions
7. Inappropriate patients due to other reasons
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Watanabe |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Pharmacology and Therapetics
Zip code
431-3192
Address
1-20-1, Hanadayama, Higashi-ku, Hamamatsu
TEL
053-435-2385
hwat@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Katayama |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Pharmacology and Therapetics
Zip code
4313192
Address
1-20-1, Hanadayama, Higashi-ku, Hamamatsu
TEL
053-435-2385
Homepage URL
katayama_20@yahoo.co.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
Tel
053-435-2850
rinri@hama-med.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 | 06 | Month | 27 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 28 | 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
Management information
Registered date
| 2016 | Year | 06 | Month | 27 | Day |
Last modified on
| 2020 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026395
