UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041852 |
|---|---|
| Receipt number | R000047776 |
| Scientific Title | Elevated urinary titin and its associated functional outcomes after acute stroke |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2021/09/21 10:19:39 |
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Basic information
Public title
Elevated urinary titin and its associated functional outcomes after acute stroke
Acronym
Elevated urinary titin and its associated functional outcomes after acute stroke
Scientific Title
Elevated urinary titin and its associated functional outcomes after acute stroke
Scientific Title:Acronym
Elevated urinary titin and its associated functional outcomes after acute stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Neurosurgery | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We prospectively investigated whether urinary titin levels were associated with outcome in stroke patients.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Our primary outcome of our study was to investigate the time course of urinary titin in patients after stroke
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
adult patients admitted in the stroke care unit.
Key exclusion criteria
not independent living before the admission (modified Rankin Scale score >= 2), > 24 hours from the onset, and other conditions to increase muscle breakdown, such as surgery or seizure.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nakanishi |
| Middle name | |
| Last name | Nobuto |
Organization
Tokushima University
Division name
Emergency and Critical Care Medicine
Zip code
770-8503
Address
2-50-1 Kuramoto, Tokushima
TEL
81-88-631-7151
nakanishi.nobuto@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Nakanishi |
| Middle name | |
| Last name | Nobuto |
Organization
Tokushima Unversity
Division name
Emergency and Critical Care Medicine
Zip code
770-8503
Address
2-50-1 Kuramoto, Tokushima
TEL
81-88-631-7151
Homepage URL
nakanishi.nobuto@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Tokushima Unversity
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
Tokushima University
Address
2-50-1 Kuramoto, Tokushima
Tel
2-50-1 Kuramoto, Tokushima
first-ec@tokushima-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
| 2020 | Year | 10 | Month | 01 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
urine of stroke patients is collected at admission, on days 3, 5 and 7, and urinary titin concentration is measured.
The outcome of stroke patients is evaluated by NIHSS, mRS, and Barthel index at discharge.
Management information
Registered date
| 2020 | Year | 09 | Month | 20 | Day |
Last modified on
| 2021 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047776
