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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032434
Receipt No. 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

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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
Institute Bell Land General Hospital
Institute
Department

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
URL(English) https://upload.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


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