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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005679
Receipt No. 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

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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
Email 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
Email ikeamane@yahoo.co.jp

Sponsor
Institute Department of Cardiology, Fukuoka University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006718

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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