UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032434
Receipt number R000036986
Scientific Title Bell Land General Hospital Myocardial Infarction Registry
Date of disclosure of the study information 2018/04/30
Last modified on 2018/04/30 18:25:57

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Basic information

Public title

Bell Land General Hospital Myocardial Infarction Registry

Acronym

BELAMI Registry

Scientific Title

Bell Land General Hospital Myocardial Infarction Registry

Scientific Title:Acronym

BELAMI Registry

Region

Japan


Condition

Condition

Completed

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate relationship between echocardiographic indices and prognosis in myocardial infarction patients.

Basic objectives2

Others

Basic objectives -Others

To investigate prognostic impact of clinical characteristics, medication and echocardiographic indices on prognosis in subgroup (myocardial infarction with reduced, mid-range or preserved ejection fraction; myocardial infarction with ischemic mitral regurgitation)

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Cardiac events defined as a composite of all-cause death and heart failure

Key secondary outcomes

All-cause death, cardiac-death, heart failure, sudden death


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

Patients after myocardial infarction who underwent echocardiographic examination at Bell Land General Hospital

Key exclusion criteria

Not applicable

Target sample size

953


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Okura

Organization

Bell Land General Hospital

Division name

Cardiology

Zip code


Address

500-3 Higashiyama, Naka-ku, Sakai-city 599-8247, Japan

TEL

072-234-2001

Email

hokura@fides.dti.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroyuki Okura

Organization

Nara Medical University

Division name

Cardiovascular Medicine

Zip code


Address

840 Shijo, Kashihara-city, Nara 634-8521,Japan

TEL

+81-744-22-3051

Homepage URL


Email

hokura@fides.dti.ne.jp


Sponsor or person

Institute

Bell Land General Hospital

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


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



Other administrative information

Date of disclosure of the study information

2018 Year 04 Month 30 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

http://heart.bmj.com/content/102/9/694.long

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

2001 Year 05 Month 17 Day

Date of IRB


Anticipated trial start date

2001 Year 05 Month 17 Day

Last follow-up date

2013 Year 04 Month 01 Day

Date of closure to data entry

2013 Year 04 Month 01 Day

Date trial data considered complete

2013 Year 04 Month 01 Day

Date analysis concluded

2017 Year 12 Month 31 Day


Other

Other related information

A total of 953 myocardial infarction was entered and followed.


Management information

Registered date

2018 Year 04 Month 30 Day

Last modified on

2018 Year 04 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036986


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name