UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047776