UMIN-CTR Clinical Trial

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

stable angina pectoris and unstable angina pectoris

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Physiological PCI Live Demonstration Office

Institute

Department

Personal name

Organization

St.JUDE MEDICAL

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Volcano Japan corporation

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

07

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Prospective observational study

Registered date

2014

Year

07

Month

03

Day

Last modified on

2014

Year

07

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016000