UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011127 |
|---|---|
| Receipt number | R000013036 |
| Scientific Title | Oita Acute Myocardial Infarction Registry |
| Date of disclosure of the study information | 2013/07/08 |
| Last modified on | 2014/02/05 11:51:47 |
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Basic information
Public title
Oita Acute Myocardial Infarction Registry
Acronym
Oita AMI Registry
Scientific Title
Oita Acute Myocardial Infarction Registry
Scientific Title:Acronym
Oita AMI Registry
Region
| Japan |
Condition
Condition
acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to elucidate the factors which may contribute to the decline the number of myocardial infarction patients and its mortality rate, by grasping the picture of the development, hospitalization, and the treatment in Oita Prefecture.
Basic objectives2
Others
Basic objectives -Others
And we will make the doctors and the inhabitants in Oita Prefecture know the study result for making use of it for the prevention of myocardial infarction and the improvement of its prognosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The characteristics of elderly patients with acute myocardial infarction (especially 75 years of age or older)
Key secondary outcomes
1)The characteristics of non-elderly patients with acute myocardial infarction (less than 65years old)
2)The relation between the elapsed time from the development and the prognosis of the patients
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who visit the hospitals in Oita Prefecture within a week after the development, and are hospitalized with the diagnosis of myocardial infarction.
Key exclusion criteria
The patients with myocardial infarction as a complication associated with percutaneous coronary intervention.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahide Hara |
Organization
Oita University, Faculty of Medicine
Division name
Department of Cardiology and Laboratory Medicine
Zip code
Address
1-banchi, 1-chome, idai-ga-oka, Hasama-machi, Yufu city, Oita Prefecture
TEL
097-586-6289
m-hara@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahide Hara |
Organization
Oita University, Faculty of Medicine
Division name
Cardiology and Laboratory Medicine
Zip code
Address
1-banchi, 1-chome, idai-ga-oka, Hasama-machi, Yufu city, Oita Prefecture
TEL
097-586-6289
Homepage URL
m-hara@oita-u.ac.jp
Sponsor or person
Institute
Oita University, Faculty of Medicine,
Department of Cardiology and Laboratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Oita Prefecture
Organization
Division
Category of Funding Organization
Local Government
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
あおぞら病院（大分県），臼杵市医師会立コスモス病院（大分県），大分医療センター（大分県），大分岡病院（大分県）大分県厚生連鶴見病院（大分県），大分県済生会日田病院（大分県），大分県立病院（大分県），大分循環器病院（大分県），大分赤十字病院（大分県），大分大学付属病院（大分県），大久保病院（大分県），杵築中央病院（大分県），健康保険南海病院（大分県），新別府病院（大分県），津久見中央病院（大分県），天心堂へつぎ病院（大分県），豊後大野市民病院（大分県），別府医療センター，村橋病院（大分県），湯布院厚生年金病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 08 | 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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 23 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 24 | Day |
Date analysis concluded
| 2014 | Year | 02 | Month | 10 | Day |
Other
Other related information
Written informed consent are obtained during acute phase hospitalization. Investigation items are patient background, physical findings, laboratory data, diagnostic imaging, treatment, and prognosis. Patient backgrounmd include date of birth, gender, development place, date of visit, way of visit, chest pain before development, and coronary risk factors. Laboratory data consist of TC, TG, HDL-C, LDL-C, BS, HbA1c, maxCK, BNP, NT-proBNP, elctrocardiogram, and ejection fraction. Diagnostic imaging are coronary
arteriogram revascularization therapy, complications, and device implantation. Prognostic item is in-hospital death. The investigation in chronic phase is done between 8 to 14 months after the onset regarding above-mentioned laboratory data, device implantation, and the chronic phase death.
Management information
Registered date
| 2013 | Year | 07 | Month | 05 | Day |
Last modified on
| 2014 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013036
