UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035941 |
|---|---|
| Receipt number | R000040929 |
| Scientific Title | FFR guided DecISion making in COronary reVascularization: Japanese multi-cEnteR retrospective RegistrY |
| Date of disclosure of the study information | 2019/02/20 |
| Last modified on | 2022/08/04 18:20:53 |
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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
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
yshiono@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040929
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| Registered date | File name |
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