UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bell Land General Hospital Myocardial Infarction Registry
Title of the study (Brief title)	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	Hiroyuki Okura
Organization	Bell Land General Hospital
Division name	Cardiology
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	Hiroyuki Okura
Organization	Nara Medical University
Division name	Cardiovascular Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2001 Year 05 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://heart.bmj.com/content/102/9/694.long
Results
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