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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||||
Condition | stroke | |||
Classification by specialty |
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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 | |
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Interventions/Control_6 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |