UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026641 |
|---|---|
| Receipt number | R000030593 |
| Scientific Title | The research about the significance of urinary titin in cardiomyopathy |
| Date of disclosure of the study information | 2017/03/22 |
| Last modified on | 2019/03/25 10:56:06 |
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Basic information
Public title
The research about the significance of urinary titin in cardiomyopathy
Acronym
Urinary titin in cardiomyopathy
Scientific Title
The research about the significance of urinary titin in cardiomyopathy
Scientific Title:Acronym
Urinary titin in cardiomyopathy
Region
| Japan |
Condition
Condition
cardiomyopathy
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the concentration of urinary titin of the patients with cardiomyopathy and the normal control.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to investigate in a cross-sectional way the correlation between the concentration of urinary titin in the patients with cardiomyopathy and normal control and the basic characteristics of participants, such as the types of cardiomyopathy, severity, and laboratory findings. This study is a preliminary research to acquire the data of urinary titin and design appropriately the future research for the feasibility to detect the cardiomyopathy using urinary titin, and is to be performed exploratorily.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The concentration of urinary titin
Key secondary outcomes
Diagnosis, sex, age, height, weight, family history, past illness, classification of NYHA, symptom, blood pressure, pulse rate, WBC, RBC, Hb, Plt, TP, Alb, AST, ALT, CK, Na, K, Cl, BUN, Cr, eGFR, BNP, urinary protein, urinary glucose, urinary RBC, %EF, IVST, PWT
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) The inpatients and outpatients of the department of cardiovascular medicine in Kobe university hospital, who have cardiomyopathy, such as dilated cardiomyopathy, hypertrophic cardiomyopathy, ischemic cardiomyopathy, congenital heart disease, and normal control.
(2) The participants with written consent.
Key exclusion criteria
The patients with myodegeneration diseases such as muscular dystrophy.
The patients after vigorous exercise or intramuscular injection such that the serum creatine kinase would be elevated .
The person who had a proposal of the cancellation about using samples for this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Seimi |
| Middle name | |
| Last name | Kobayashi |
Organization
Kobe university hospital
Division name
The department of cardiovascular medicine
Zip code
6500017
Address
7-5-2, Kusunoki-cho, Cyuo-ku, Kobe city, Hyogo
TEL
0783825846
seimik@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Matsumoto |
| Middle name | |
| Last name | Kensuke |
Organization
Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name
Division of cardiovascular medicine
Zip code
6500017
Address
7-5-2, Kusunoki-cho, Cyuo-ku, Kobe city, Hyogo
TEL
0783825846
Homepage URL
kenmatsu@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe university
Institute
Department
Personal name
Funding Source
Organization
Kobe university
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Agency for Medical Research and Deveopement
IRB Contact (For public release)
Organization
Division of cardiovascular medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Address
7-5-2, Kusunoki-cho, Cyuo-ku, Kobe city, Hyogo
Tel
0783825846
seimik@med.kobe-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
神戸大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 22 | 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
61
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
| 2017 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: preliminary exploratory research
Participants: the inpatients and outpatients of the department of cardiovascular medicine in Kobe university hospital from March 2017 to March 2018, with written consent and be coincident with a selection standard, and normal control(healthy volunteer), who are recruited by the poster.
Measurement items: diagnosis, sex, age, height, weight, family history, past illness, classification of NYHA, symptom, blood pressure, pulse rate, WBC, RBC, Hb, Plt, TP, Alb, AST, ALT, CK, Na, K, Cl, BUN, Cr, eGFR, BNP, urinary protein, urinary glucose, urinary RBC, %EF, IVST, PWT.
Management information
Registered date
| 2017 | Year | 03 | Month | 22 | Day |
Last modified on
| 2019 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030593
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