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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014473
Receipt No. R000016000
Scientific Title Long-term outcomes of Japanese patients with deferral of coronary intervention based on fractional flow reserve in multicenter registry
Date of disclosure of the study information 2014/07/07
Last modified on 2014/07/03

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Basic information
Public title Long-term outcomes of Japanese patients with deferral of coronary intervention based on fractional flow reserve in multicenter registry
Acronym J-CONFIRM Registry
Scientific Title Long-term outcomes of Japanese patients with deferral of coronary intervention based on fractional flow reserve in multicenter registry
Scientific Title:Acronym J-CONFIRM Registry
Region
Japan

Condition
Condition stable angina pectoris and unstable angina pectoris
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the long term event rate and risk factors that affect long term prognosis for clinical cases in Japan in which PCI was deferred based on an FFR >0.8 measurement (DEFER group). To perform a comparative investigation into the long term prognosis of the DEFER group, a control group in which PCI was performed in cases with an FFR>0.8 measurement (PCI group) will be enrolled. Additionally, cases that are deferred because it is judged that PCI will not produce a satisfactory clinical result despite an FFR ≤0.8 measurement will also be enrolled (Non-PCI group), and the respective event rate will be evaluated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Primary outcome is target vessel failure (TVF) at 2-year. TVFis defined as a composite of cardiac death related to target vessel, myocardial infarction, and clinically driven target vessel revascularization.
Key secondary outcomes 1) Annual TVF at 1, 2, 3, 4, and 5 years
2) Annual Major Adverse Cardiac and Cerebrovascular Events (MACCE) and in-stent thrombosis at 1, 2, 3, 4, and 5 years
3) Annual MACCE according to success of coronary risk factor management control via pharmacotherapy at 1, 2, 3, 4, and 5 years
4) Annual MACCE for dialysis cases at 1, 2, 3, 4, and 5 years
5) Annual MACCE for stented and non-stent (de novo) lesions at 1, 2, 3, 4, and 5 years
6) Annual MACCE for diabetes and non-diabetes cases at 1, 2, 3, 4, and 5 years
7) Factorial analysis of patient background of MACCE event group and non-event group
8) Sub-group analysis of Annual MACCE rates for PCI group, DEFER group and Non-PCI group at 1, 2, 3, 4, and 5 years
9) Annual MACCE sub-grouped by iFR measurement (optional measurement item) at 1, 2, 3, 4, and 5 years

*MACCE is defined as all mortality, non-fatal MI, stroke, and Clinically driven PCI or CABG.

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 (I) Patients were clinically suspected of angina pectoris and underwent coronary angiography.
(II) Coronary angiography showed more than 50% diameter stenosis by visual estimation and FFR examination was done.
(III) Patients fulfilled (I),(II) and any one of the following criteria: 1) defered PCI based on FFR >0.80; 2) underwent PCI regardless of FFR >0.80; and 3) defered PCI regardless of FFR ≤0.80.
Key exclusion criteria 1) ST and non-ST elevated myocardial infarction
2) emergent percutaneous coronary intervention
3) cardiogenic shock (Killip class IV)
4) lesion with chronic total occlusion
5) limited life expectancy due to cancer
6) inability to give informed consent
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiro Tanaka, Hiroyoshi Yokoi
Organization Tokyo Medical University, Fukuoka Sanno Hospital
Division name Cardiology
Zip code
Address 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo; 3-6-45 Momochihama, Sawara-ku, Fukuoka
TEL 092-832-1100
Email hiroyokoi@circus.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoichi Kuramitsu
Organization Kokura Memorial Hospital
Division name Cardiology
Zip code
Address 3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka
TEL 093-511-2000
Homepage URL
Email kuramitsu@circulation.jp

Sponsor
Institute Physiological PCI Live Demonstration Office
Institute
Department

Funding Source
Organization St.JUDE MEDICAL
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Volcano Japan corporation
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
2014 Year 07 Month 07 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
2013 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 09 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 Prospective observational study

Management information
Registered date
2014 Year 07 Month 03 Day
Last modified on
2014 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016000

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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