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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041852
Receipt No. 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 2020/09/21

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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
Email 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
Email nakanishi.nobuto@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

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
Email 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
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2020 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047776

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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