UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028652 |
|---|---|
| Receipt number | R000032793 |
| Scientific Title | Kumamoto University Malignancy and Atheroscrelosis study |
| Date of disclosure of the study information | 2017/08/20 |
| Last modified on | 2018/02/12 08:06:55 |
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Basic information
Public title
Kumamoto University Malignancy and Atheroscrelosis study
Acronym
KUMA study
Scientific Title
Kumamoto University Malignancy and Atheroscrelosis study
Scientific Title:Acronym
KUMA study
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
With progress in medical technology, cardiovascular events in cancer survivors are attracting attention.
Basic objectives2
Others
Basic objectives -Others
We sought to examine whether the differential incidence of cardiovascular events after percutaneous coronary intervention with or without malignant diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
target lesion revascularization(TLR) within 1-year
Key secondary outcomes
total cardiovascular event (cardiovascular death, nonfatal myocardial infarction, unstable angina pectoris, TLR, non TLR revascularization and hospitalization for heart failure decompensation).
All-cause death
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
Those who received percutaneous coronary intervention in our department.
Key exclusion criteria
none
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Sueta |
Organization
Kumamoto University
Division name
Cardiovacular Medicine
Zip code
Address
1-1-1 Honjo
TEL
096-373-5175
sueta-d@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Sueta |
Organization
Kumamoto University
Division name
Cardiovacular Medicine
Zip code
Address
1-1-1 Honjo
TEL
096-373-5175
Homepage URL
sueta-d@kumamoto-u.ac.jp
Sponsor or person
Institute
Cardiovacular Medicine, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Address
Tel
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
| 2017 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
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
Main results already published
Date of protocol fixation
| 2007 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 08 | Month | 13 | Day |
Last modified on
| 2018 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032793
