UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060259 |
|---|---|
| Receipt number | R000068926 |
| Scientific Title | Very long-term follow-up of ischemic heart disease after index PCI - cumulative events and secondary prevention |
| Date of disclosure of the study information | 2026/01/09 |
| Last modified on | 2026/01/05 15:31:53 |
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Basic information
Public title
Very long-term follow-up of ischemic heart disease after index PCI - cumulative events and secondary prevention
Acronym
Very long-term follow-up of ischemic heart disease after index PCI
Scientific Title
Very long-term follow-up of ischemic heart disease after index PCI - cumulative events and secondary prevention
Scientific Title:Acronym
Very long-term follow-up of ischemic heart disease after index PCI
Region
| Japan |
Condition
Condition
ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Shizuoka City has a limited number of medical institutions capable of performing primary PCI, and medical resources are limited, but it is relatively easy to track patients who have undergone intervention over the long term.
We will conduct ultra-long-term follow-up of PCI cases at our facility for more than 10 years to evaluate the effectiveness and characteristics of treatment. While the study will primarily be observational, some will involve continuous intervention in collaboration with hospitals and clinics, and fatal events will be avoided by optimal drug therapy based on the latest evidence and early testing to identify signs of disease recurrence.
In addition, we will use the overall observation of long-term prognosis to build a foundation for building evidence for better secondary prevention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major adverse cardiac and cerebrovascular events at the end of 2025 December
Key secondary outcomes
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
Established ischemic heart disease with index PCI procedure(s)
Key exclusion criteria
those who do not reach 1 year follow-up
Target sample size
3800
Research contact person
Name of lead principal investigator
| 1st name | Shigetaka |
| Middle name | |
| Last name | Kageyama |
Organization
Shizuoka City Shizuoka Hospital
Division name
Department of Cardiology
Zip code
4200883
Address
10-93 Ohtemachi Aoi-ku Shizuoka
TEL
054-253-3125
shigenewf@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shigetaka |
| Middle name | |
| Last name | Kageyama |
Organization
Shizuoka City Shizuoka Hospital
Division name
Department of Cardiology
Zip code
4200883
Address
10-93 Ohtemachi Aoi-ku Shizuoka
TEL
054-253-3125
Homepage URL
shigenewf@yahoo.co.jp
Sponsor or person
Institute
Shizuoka City Shizuoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka City Shizuoka Hospital
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
Shizuoka City Shizuoka Hospital
Address
10-93 Ohtemachi Aoi-ku Shizuoka
Tel
054-253-3125
chiken2@shizuokahospital.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
| 2026 | Year | 01 | Month | 09 | 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
3739
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 01 | Month | 05 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068926
