UMIN-CTR Clinical Trial

Basic information
Public title	FFR guided DecISion making in COronary reVascularization: Japanese multi-cEnteR retrospective RegistrY
Acronym	FFR DISCOVERY Japan
Scientific Title	FFR guided DecISion making in COronary reVascularization: Japanese multi-cEnteR retrospective RegistrY
Scientific Title:Acronym	FFR DISCOVERY Japan
Region	Japan

Condition
Condition	Coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1) To elucidate the prognosis of patients after fractional flow reserve assessments 2) To clarify the optimal cut-off value of FFR for coronary revascularization on the basis of clinical outcomes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	time to event for cardiac death, myocardial infarction, and target lesion 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 who underwent fractional flow reserve assessment in one or more coronary arteries
Key exclusion criteria	1) Infarct related artery 2) Bypass graft 3) Thrombolysis in myocardial infarction flow (TIMI) <3 4) Overt heart failure 5) Severe valvular disease or cardiomyopathy (Hypertrophic, dilated, or restrictive cardiomyopathy) 6) Limited life expectancy (less than 12 months) 7) If patients or their family elect to opt out of study participation
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Akasaka
Organization	Wakayama Medical University
Division name	Department of cardiovascular medicine
Zip code	641-8510
Address	811-1 Kimiidera Wakayama Japan
TEL	073-447-2300
Email	akasat@wakayama-med.acj.jp

Public contact
Name of contact person	1st name Yasutsugu Middle name Last name Shiono
Organization	Wakayama Medical University
Division name	Department of cardiovascular medicine
Zip code	641-8510
Address	811-1 Kimiidera Wakayama Japan
TEL	073-447-2300
Homepage URL
Email	yshiono@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Japan Heart Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Wakayama Medical University
Address	811-1 Kimiidera Wakayama Japan
Tel	073-447-2300
Email	wa-rinri@wakayama-med.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	和歌山県立医科大学　(和歌山県) 東京医科大学 (東京都) 東京医科大学八王子医療センター (東京都) 岐阜ハートセンター (岐阜県) 京都第二赤十字病院 (京都府) 愛知医科大学 (愛知県) 江戸川病院 (東京都)

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 20 Day

Related information
URL releasing protocol	NA
Publication of results	Unpublished

Result
URL related to results and publications	NA
Number of participants that the trial has enrolled	5007
Results	A total of 5004 patients who underwent FFR measurement between 2010 and 2016 were enrolled and were followed until March 2020. Of those, 2886 patients underwent revascularization after FFR measurements. During the follow up, 87 patients suffered from cardiac death and 59 patients suffered non-fatal myocardial infarction.
Results date posted	2022 Year 08 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Among the patients enrolled in this study, 3728 (74.5%) were men, the average age was 69.7, 3783(75.6%) had chronic coronary syndrome, 659 (13.2%) had prior myocardial infarction, 421 (8.4%) had unstable angina, 118 (2.4%) had ST-segment elevated myocardial infarction, and 23 (0.5%) had non-ST-segment elevated myocardial infarction. 4026 (80.5) patients had hypertension, 3354 (67%) had dyslipidemia, 2098 (41.9%) had diabetes mellitus, 1268 (25.3%) had prior myocardial infarction, 462 (9.2%) had chronic kidney disease, 340 were on hemodyalysis, 541 (10.8%) had peripheral artery disease, 499 (10.0%) had prior stroke, and 384 (7.7%) had atrial fibrillation.
Participant flow	Between January 2010 and December 2016, 5007 patients who underwent FFR evaluation were screened, 2 did not meet the inclusion criteria, and 1 met the exclusion criteria. In the end, 50004 patients were enrolled and were followed until March 2020.
Adverse events	No adverse event related to this study was observed due to the nature of the retrospective study.
Outcome measures	During the follow up, 87 patients suffered from cardiac death and 59 patients suffered non-fatal myocardial infarction. The cumulative incidence of cardiac death was 0.44% at 1 year, 1.27% at 3 year, and 2.3% at 5 year. With regard to non-fatal myocardial infarction, the cumulative incidence was 0.27% at 1 year, 0.8% at 3 year, and 1.54% at 5 year.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 20 Day
Date of IRB	2018 Year 03 Month 13 Day
Anticipated trial start date	2019 Year 03 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective cohort study

Management information
Registered date	2019 Year 02 Month 19 Day
Last modified on	2022 Year 08 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040929