UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036020 |
|---|---|
| Receipt number | R000041031 |
| Scientific Title | Mie Acute Coronary Syndrome Registry |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/08/28 14:25:55 |
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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
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
takasakiman@gmail.com
Sponsor or person
Institute
Mie University Hospital, CCU Network Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041031
