UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035587 |
|---|---|
| Receipt number | R000040552 |
| Scientific Title | A prospective registry for the surveillance to improve the management of coronary artery disease: Juntendo Physicians Alliance for Clinical Trials (J-PACT) PCI database. |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2024/07/24 16:59:40 |
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Basic information
Public title
A prospective registry for the surveillance to improve the management of coronary artery disease: Juntendo Physicians Alliance for Clinical Trials (J-PACT) PCI database.
Acronym
J-PACT PCI registry
Scientific Title
A prospective registry for the surveillance to improve the management of coronary artery disease: Juntendo Physicians Alliance for Clinical Trials (J-PACT) PCI database.
Scientific Title:Acronym
J-PACT PCI registry
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Surveillance to improve the management of coronary artery disease
Basic objectives2
Others
Basic objectives -Others
To investigate the clinical outcomes in patients who underwent percutaneous coronary intervention
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year cumulative incidence of all-cause death in patients who underwent percutaneous coronary intervention
Key secondary outcomes
5-year cumulative incidence of major adverse cardiac and cerebrovascular events including non-fatal myocardial infarction, non-fatal stroke, and revascularization
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent coronary angiography or percutaneous coronary intervention
Key exclusion criteria
None
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Katsumi |
| Middle name | |
| Last name | Miyauchi |
Organization
Juntendo University, Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-0033
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
ktmmy@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Nishio |
Organization
Juntendo University, Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
1130033
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
r-nishio@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Graduate School of Medicine
Department of Cardiovascular Biology and Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo Hospital institutional review board
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-3111
kenkyu5858@juntendo.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
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
| 2027 | Year | 11 | Month | 24 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical characteristics, laboratory data, and medication data.
Clinical outcomes after percutaneous coronary intervention from medical chart or questionnaire
Management information
Registered date
| 2019 | Year | 01 | Month | 18 | Day |
Last modified on
| 2024 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040552
