UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005679 |
|---|---|
| Receipt number | R000006718 |
| Scientific Title | The relation between the medical parameters and short- or long-term clinical outcome in patients with percutaneous coronary intervention (PCI) |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2020/02/13 13:05:18 |
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Basic information
Public title
The relation between the medical parameters and short- or long-term clinical outcome in patients with percutaneous coronary intervention (PCI)
Acronym
FU-Registry
Scientific Title
The relation between the medical parameters and short- or long-term clinical outcome in patients with percutaneous coronary intervention (PCI)
Scientific Title:Acronym
FU-Registry
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The relation between the medical parameters and short- or long-term clinical outcome in patients with percutaneous coronary intervention (PCI)
Basic objectives2
Others
Basic objectives -Others
Cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of parameters related to clinical events (death from all causes, cardiac infarction, cerebral infarction, or target lesion revascularization (TLR)) for 9 months after percutaneous coronary intervention (PCI)
Key secondary outcomes
Analysis of parameters related to evaluation of coronary angiography (instent restenosis, late loss, stent length, calcifications, % diameter stenosis, etc) at 9 months after coronary intervention as assessed by quantitative coronary angiography (QCT). Data from Intravascular ultrasound (IVUS) are also assessed.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergone coronary intervention in Fukuoka Unversity Hospital, Fukuoka Unversity Chikusshi Hospital, and Hakujyuji Hospital
Key exclusion criteria
nothing
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | keijiro |
| Middle name | |
| Last name | Saku |
Organization
Fukuoka University Schoolof Medicine
Division name
Department of Cardiology
Zip code
8148722
Address
7-45-1 Nanakuma Jonan-ku, Fukuoka, Japan
TEL
0928011011
saku-k@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Amane |
| Middle name | |
| Last name | Ike |
Organization
Fukuoka University Schoolof Medicine
Division name
Department of Cardiology
Zip code
8148722
Address
7-45-1 Nanakuma Jonan-ku, Fukuoka, Japan
TEL
092-801-1011
Homepage URL
ikeamane@yahoo.co.jp
Sponsor or person
Institute
Department of Cardiology, Fukuoka University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Fukuoka University Medical Ethics Committee
Address
7-45-1 Nanakuma Jonan-ku, Fukuoka, Japan
Tel
092-801-1011
fumed-ethics@fukuoka-u.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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2009 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The relation between the medical parameters and short- or long-term clinical outcome (death from all causes, cardiac infarction, cerebral infarction, or target lesion revascularization (TLR) etc)in patients with percutaneous coronary intervention (PCI)
Management information
Registered date
| 2011 | Year | 05 | Month | 31 | Day |
Last modified on
| 2020 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006718
