UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004736 |
|---|---|
| Receipt number | R000005598 |
| Scientific Title | Japan Cardiovascular Database, Percutaneous Coronary Intervention Registry |
| Date of disclosure of the study information | 2010/12/16 |
| Last modified on | 2024/05/10 15:24:40 |
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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
Quality Indicator (QI) items, short-term and long-term cardiovascular events
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
36000
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Kohsaka |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku Tokyo Japan
TEL
03-5363-3793
sk@keio.jp
Public contact
Name of contact person
| 1st name | Ikuko |
| Middle name | |
| Last name | Ueda |
Organization
KICS Steering Committee
Division name
Department of Cardiology, Keio University School of Medicine
Zip code
160-8582
Address
35 Shinanomachi Shinjuku Tokyo Japan
TEL
03-3353-1211
Homepage URL
kicskeio@gmail.com
Sponsor or person
Institute
Department of Cardiology, Keio University
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Co Ltd, Japan Society for Promotion of Science
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
IRB, Keio University, School of Medicine
Address
35 Shinanomachi Shinjuku Tokyo Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
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
| 2008 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
PCI-related complications and short- and long-term outcomes will be corrected for severity and presented. 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
| 2024 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005598
