UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000779 |
|---|---|
| Receipt number | R000000887 |
| Scientific Title | Assessment study on validity of the Intervention Therapies for coronary artery disease in Japan |
| Date of disclosure of the study information | 2007/09/01 |
| Last modified on | 2007/07/26 16:25:24 |
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Basic information
Public title
Assessment study on validity of the Intervention Therapies for coronary artery disease in Japan
Acronym
Assessment study on validity of the Intervention Therapies for coronary artery disease in Japan<AVIT-J>
Scientific Title
Assessment study on validity of the Intervention Therapies for coronary artery disease in Japan
Scientific Title:Acronym
Assessment study on validity of the Intervention Therapies for coronary artery disease in Japan<AVIT-J>
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the effect of drug-eluting stent by archiving coronary artery disease cases treated in National Hospital Organization institutions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Symptoms at firstyear,second year and third year follow-up.
Key secondary outcomes
Incidence of Major Adverse Cardiac Evevts at first year,second year and third year 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 with coronary artery disease.
Key exclusion criteria
1.Patients with acute myocardial infarction treated by only thrombolytic therapy.
2.Under 20 years old.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Hiyamuta |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Cardiology
Zip code
Address
1-8-1Jigyouhama,chuo-ku,Fukuoka city,Fukuoka
TEL
092-852-0700
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saiko Umeno |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Cardiology
Zip code
Address
1-8-1Jigyouhama,chuo-ku,Fukuoka city,Fukuoka
TEL
092-852-0700
Homepage URL
saiko@kyumed.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2007 | Year | 09 | 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
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
Date of protocol fixation
| 2007 | Year | 07 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Prospective observational study.
Management information
Registered date
| 2007 | Year | 07 | Month | 26 | Day |
Last modified on
| 2007 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000887
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
