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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006979
Receipt No. R000008236
Scientific Title Significance of FFR measurements just after DES implantation for the prediction of prognosis
Date of disclosure of the study information 2012/01/01
Last modified on 2017/03/01

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Basic information
Public title Significance of FFR measurements just after DES implantation for the prediction of prognosis
Acronym The prediction of prognosis just after DES implantation
Scientific Title Significance of FFR measurements just after DES implantation for the prediction of prognosis
Scientific Title:Acronym The prediction of prognosis just after DES implantation
Region
Japan

Condition
Condition stable angina pectoris, unstable angina pectoris, acute myocardial infarction, old myocardial infarction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the significance of FFR measurements just after DES implantation for the prediction of prognosis
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes death, myocardial infarction, cerebrovascular accident, target vessel revascularization
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients, whose FFR and pull-back intracoronary pressure were measured just after DES implantation
Key exclusion criteria 1) Patients, with DES implantation for vessels receiving collateral perfusion
2) Patients treated with 2-stents-stratery for bifurcate lesion
3) Patients, treated for same vessels that have been already implanted DES in
4) Patients, planned PCI for other vessels than DES implanted
5) Patients, post CABG
6) Patients, apparantly having cardiomyopathy
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiro Tanaka
Organization Tokyo Medical University Hospital
Division name Department of Cardiology
Zip code
Address 6-7-1Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL 03-3342-6111
Email n-tanaka@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yohe Hokama
Organization Tokyo Medical University Hospital
Division name Department of Cardiology
Zip code
Address 6-7-1Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL 03-3342-6111
Homepage URL
Email y-hokama@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University Hospital
Institute
Department

Funding Source
Organization Tokyo Medical University Hospital
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
Email

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
2012 Year 01 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
2012 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2012 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
2011 Year 12 Month 28 Day
Last modified on
2017 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008236

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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