UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009635 |
|---|---|
| Receipt number | R000010380 |
| Scientific Title | The study of the effect of amino acid metabolism on coronary artery disease |
| Date of disclosure of the study information | 2013/01/01 |
| Last modified on | 2016/01/07 12:14:41 |
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Basic information
Public title
The study of the effect of amino acid metabolism on coronary artery disease
Acronym
The study of the effect of amino acid metabolism on coronary artery disease
Scientific Title
The study of the effect of amino acid metabolism on coronary artery disease
Scientific Title:Acronym
The study of the effect of amino acid metabolism on coronary artery disease
Region
| Japan |
Condition
Condition
coronary artery disease, and other cardiac disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We asses the serum levels of NO-related amino acids including arginine, homocysteine, dimethylarginine and its association with plevalance or svererity of coronary aretry disease. Moreover, we also assese the prognostic values.
Basic objectives2
Others
Basic objectives -Others
Oxidative stress markers are also investigated.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence of coronary artery disease.
Key secondary outcomes
Severeity, number of diseased vessels, carcificatoin score of coronary artery disease, and other results of cardiovascular physiological examinations.
The prognosis and cardiac events after long follow up.
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
Patients reffered to coronary angiography or coronary CT for diagnosis of coronary artery disease.
Key exclusion criteria
Patients less than 20 years old are exculded.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Adachi |
Organization
National Defence Medical College
Division name
Department of cardiology
Zip code
Address
3-2Namiki Tokorozawa
TEL
0429-95-1511
con320@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Masaki |
Organization
National Defence Medical College
Division name
Department of cardiology
Zip code
Address
3-2 Namiki Tokorozawa Saitama Japan
TEL
0429-95-1511
Homepage URL
con320@ndmc.ac.jp
Sponsor or person
Institute
National Defence Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defence Medical College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
| 2013 | Year | 01 | 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
Results
Now,registrating patients
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | 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
Now,registrating patients
Management information
Registered date
| 2012 | Year | 12 | Month | 26 | Day |
Last modified on
| 2016 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010380
| 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 |
