UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042266 |
|---|---|
| Receipt number | 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 | 2021/05/02 12:52:44 |
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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
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
kanesannsann@yahoo.co.jp
Sponsor or person
Institute
Kokura memorial hospital
Institute
Department
Personal name
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
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
| 2021 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
