UMIN-CTR Clinical Trial

Basic information
Public title	Mie Acute Coronary Syndrome Registry
Acronym	Mie ACS Registry
Scientific Title	Mie Acute Coronary Syndrome Registry
Scientific Title:Acronym	Mie ACS Registry
Region	Japan

Condition
Condition	Acute Coronary Syndrome
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the treatment situation from the onset to acute, chronic phase and clinical practice related to prognosis in patients with acute coronary syndrome in Mie prefecture. And to analyze the problems and trends in whole prefecture and each medical region.
Basic objectives2	Others
Basic objectives -Others	all cause mortality, ischemic event
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	all cause mortality until 2 years from onset
Key secondary outcomes	cardiovascular death, non cardiovascular death, nonfatal myocardial infarction, re-hospitalization due to heart failure, re-vascularization, nonfatal cerebrovascular disease until 2 years from onset.

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	patient diagnosed as acute coronary syndrome
Key exclusion criteria	not appricable
Target sample size	6000

Research contact person
Name of lead principal investigator	1st name Masaaki Middle name Last name Ito
Organization	Mie University Hospital
Division name	Department of Cardiology
Zip code	514-8507
Address	2-174 edobashi, Tsu, Mie
TEL	059-232-1111
Email	mitoka@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	1st name Akihiro Middle name Last name Takasaki
Organization	CCU Network Center
Division name	CCU Network Center
Zip code	514-8507
Address	2-174 edobashi, Tsu, Mie
TEL	059-232-1111
Homepage URL
Email	takasakiman@gmail.com

Sponsor
Institute	Mie University Hospital, CCU Network Center
Institute
Department

Funding Source
Organization	not appricable English name
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Mie University Hospital
Address	2-174 edobashi, Tsu, Mie
Tel	059-232-1111
Email	takasakiman@gmail.com

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	2019 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Open public recruiting
Date of protocol fixation	2012 Year 06 Month 01 Day
Date of IRB	2015 Year 03 Month 13 Day
Anticipated trial start date	2013 Year 01 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study Multi-Center study

Management information
Registered date	2019 Year 02 Month 26 Day
Last modified on	2019 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041031