UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013914 |
|---|---|
| Receipt number | R000016225 |
| Scientific Title | Investigation of the risk factors of cardiovascular disease in total health check(THC) |
| Date of disclosure of the study information | 2014/05/09 |
| Last modified on | 2014/08/07 19:03:32 |
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Basic information
Public title
Investigation of the risk factors of cardiovascular disease in total health check(THC)
Acronym
Investigation of the risk factors of cardiovascular disease in total health check(THC)
Scientific Title
Investigation of the risk factors of cardiovascular disease in total health check(THC)
Scientific Title:Acronym
Investigation of the risk factors of cardiovascular disease in total health check(THC)
Region
| Japan |
Condition
Condition
cardiovascular disease, metabolic syndrome, hypertension, diabetes mellitus, dyslipidemia
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
| Pneumology | Endocrinology and Metabolism | Nephrology |
| Neurology | Geriatrics | Ophthalmology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate which risk factor is the caused of the cardiovascular disease in the healthy subjects
Basic objectives2
Others
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of cardiovascular disease
Key secondary outcomes
The abnormal data obtained from echocardiography, electrocardiogram, chest computed tomography, carotid ultrasonography, and head magnetic resonance imaging
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The healthy subject underwent a thorough physical examination including tissue Doppler echocardiography
Key exclusion criteria
diabetes mellitus, systolic dysfunction, or other heart diseases
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Kawana |
Organization
Aoyama Hospital, Tokyo Women's Medical university
Division name
Cardiology
Zip code
Address
2-7-13 Kita-Aoyama, Minato-ku, Tokyo, Japan
TEL
+81-35411-8111
mkawana@hij.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruki Sekiguchi |
Organization
Tokyo Women's Medical University
Division name
Cardiology
Zip code
Address
8-1 Kawada-cho, Shinjyuku, Tokyo, Japan
TEL
+81-33353-8111
Homepage URL
sekiguchi.haruki@twmu.ac.jp
Sponsor or person
Institute
Aoyama Hospital, Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Aoyama Hospital, Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
| 2012 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective cohort study
Management information
Registered date
| 2014 | Year | 05 | Month | 09 | Day |
Last modified on
| 2014 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016225
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
