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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name