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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004736
Receipt No. R000005598
Scientific Title Japan Cardiovascular Database, Percutaneous Coronary Intervention Registry
Date of disclosure of the study information 2010/12/16
Last modified on 2017/02/27

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Basic information
Public title Japan Cardiovascular Database,
Percutaneous Coronary Intervention
Registry
Acronym JCD-PCI
Scientific Title Japan Cardiovascular Database,
Percutaneous Coronary Intervention
Registry
Scientific Title:Acronym JCD-PCI
Region
Japan North America

Condition
Condition Patient with coronary artery disease who underwent PCI
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To delineate the clinical characteristics of PCI patients, and compare the adjusted outcomes between participating institutions to secure the safety of the procedure.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Adjusted in-hospital mortality rate
Key secondary outcomes Adjusted in-hospital complication rate

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All the patients who underwent PCI.
Key exclusion criteria None
Target sample size 30000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shun Kohsaka
Organization Keio University School of Medicine
Division name Department of Cardiology
Zip code
Address 35 Shinanomachi Shinjuku Tokyo Japan
TEL 03-5363-3793
Email sk@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ikuko Ueda
Organization KICS Steering Committee
Division name Department of Cardiology, Keio University School of Medicine
Zip code
Address 35 Shinanomachi Shinjuku Tokyo Japan
TEL 03-3353-1211
Homepage URL
Email kicskeio@gmail.com

Sponsor
Institute Department of Cardiology, Keio University
Institute
Department

Funding Source
Organization Daiichi Sankyo Co Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

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
2010 Year 12 Month 16 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2008 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The calculated mortality and complication rate will be used for patient care and quality improvement of each hospital.

Management information
Registered date
2010 Year 12 Month 16 Day
Last modified on
2017 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005598

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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