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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042266
Receipt No. R000048170
Scientific Title A retrospective observational study of prognostic factors and clinical outcomes in patients who underwent percutaneous coronary intervention
Date of disclosure of the study information 2020/11/15
Last modified on 2020/10/28

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Basic information
Public title A retrospective observational study of prognostic factors and clinical outcomes in patients who underwent percutaneous coronary intervention
Acronym Kokura PCI Registry
Scientific Title A retrospective observational study of prognostic factors and clinical outcomes in patients who underwent percutaneous coronary intervention
Scientific Title:Acronym Kokura PCI Registry
Region
Japan

Condition
Condition Ischemic heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the current status of treatment and clinical outcomes and to survey the prognostic factors in patients with PCI
Basic objectives2 Others
Basic objectives -Others retrospective cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Composite of cardiovascular death, bleeding, myocardial infarction, stroke, stent thrombosis
all-cause death
bleeding events
Key secondary outcomes cardiovascular death
noncardiovascular death
ischemic or embolic events

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 Patients underwent their PCI
Key exclusion criteria Age < 18
Target sample size 4800

Research contact person
Name of lead principal investigator
1st name Yamaji
Middle name
Last name Kyohei
Organization Kokura memorial hospital
Division name cardiology
Zip code 8028555
Address Asano3-2-1, Kokurakita-ku, Kitakyusyu-shi
TEL 093-511-2000
Email kyohei@yamaji.info

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Kanenawa
Organization Kokura memorial hospital
Division name cardiology
Zip code 8028555
Address Asano3-2-1, Kokurakita-ku, Kitakyusyu-shi
TEL 093-511-2000
Homepage URL
Email kanesannsann@yahoo.co.jp

Sponsor
Institute Kokura memorial hospital
Institute
Department

Funding Source
Organization Not applicable
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 linical research center,Kokura Memorial Hospital
Address 3-2-1 Asano, Kokura kita-ku,Kitakyushu-city,
Tel 0935112000
Email crc@kokurakinen.or.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
2020 Year 11 Month 15 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 4800
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
2020 Year 10 Month 15 Day
Date of IRB
2020 Year 10 Month 23 Day
Anticipated trial start date
2020 Year 10 Month 23 Day
Last follow-up date
2021 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective cohort study

Management information
Registered date
2020 Year 10 Month 28 Day
Last modified on
2020 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048170

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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