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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014706
Receipt No. R000017094
Scientific Title Assessing Optimal percutaneous coronary Intervention for LMCA Registry
Date of disclosure of the study information 2014/07/30
Last modified on 2016/01/31

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Basic information
Public title Assessing Optimal percutaneous coronary Intervention for LMCA Registry
Acronym AOI LMCA registry
Scientific Title Assessing Optimal percutaneous coronary Intervention for LMCA Registry
Scientific Title:Acronym AOI LMCA registry
Region
Japan

Condition
Condition Left main coronary artery stenosis including myocardial infarction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the safety and efficacy of percutaneous coronary artery intervention treatment for unprotected left main coronary artery disease by analysis of cardiovascular severe adverse events.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes All-cause death
Cardiovascular death
Key secondary outcomes Target lesion revascularization
etc.

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
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients who have left main coronary artery disease
Key exclusion criteria no exclusion
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimura Takeshi
Organization Graduate School of Medicine, Kyoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoin Kawaharacho Sakyo-ku Kyoto 606-8507 Japan
TEL 075-751-4254
Email taketaka@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Higami Hirooki
Organization Graduate School of Medicine, Kyoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoin Kawaharacho Sakyo-ku Kyoto 606-8507 Japan
TEL 075-751-4255
Homepage URL
Email hhigami@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization None
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
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
2014 Year 07 Month 30 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 Preinitiation
Date of protocol fixation
2014 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Investigation for patients' background, lesion characteristics, cardiovascular severe adverse events, and all-cause death.

Management information
Registered date
2014 Year 07 Month 30 Day
Last modified on
2016 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017094

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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